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I234Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol
Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol

Complexity Level: 1

Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients must consent to undergo genomic screening. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed.

Objectives: Primary Objective - To centrally genotype cfDNA from patients with mCRPC progressing after a "next-generation" AR-pathway inhibitor in order to facilitate accrual to targeted therapy trials and then to assess the clinical benefit rate (CBR), of each Study Drug. Secondary Objectives - To determine the effect of each Study Drug on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of each Study Drug in mCRPC patients. Tertiary Objectives - To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Planned
I234AA Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastiatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
A Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastiatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients without history of hypersensitivity to AZD1775 or any of its excipients or who have not received treatment with drugs with a similar mechanism of action. Patients witout any factors that increase the risk of QTc prolongation or risk of arrhythmic events or mean resting corrected QT interval (QTc) <= 470 msec. Patients on drugs with a narrow therapeutic index which are substrates of BRCP, PGP, CYP2C19 or CYP1A2, inhibitors of PGP, and which cannot be discontinued or changed to alternative drugs are not eligible.

Objectives: To determine the effect of AZD1775 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of AZD1775 in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Michael Kolinsky, Cross Cancer Institute, (780) 432-8762


Planned
I234BA Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
A Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234.Men of childbearing potential must have agreed to use a highly effective contraceptive method during Study Drug treatment and for 6 months after stopping treatment and should not father a child or donate sperm during this period. Patients with significantly abnormal liver diseases including viral/other hepatitis, current alcohol abuse or cirrhosis are not eligible. Patients in whom strong inducers or inhibitors of CYP3A4 and strong inhibitors of CYP1A2 cannot be discontinued within 2 weeks before the first dose of savolitinib (3 weeks for St John's Wort) are not eligible..

Objectives: To determine the effect of savolitinib on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of savolitinib in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Som Mukherjee, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


Planned
I234CA Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234
A Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Serum potassium within normal limits. Prior abiraterone acetate or enzalutamide but not both. No prior cytotoxic systemic chemotherapy in the CRPC setting.

Objectives: To determine the effect of darolutamide on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of darolutamide in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Michael Ong, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 75051


Planned
I214A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients with Incurable Advanced/Metastatic MAGE-A3-Expressing Solid Tumours
A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients with Incurable Advanced/Metastatic MAGE-A3-Expressing Solid Tumours

Complexity Level: 1

Eligibility: Patients with histologically confirmed, unresectable locally advanced/metastatic solid tumour (Phase I - Esophogeal/GEJ/gastric, NSCLC and breast, fallopian tube, bladder, adenocystic, anal, melanoma, periampullary, renal, liver, vulvar and ovarian). Tumour must be MAGE-A3 positive. Patient must have have at least one additional tumour mass amenable to core or excisional biopsy and must consent and be willing to undergo at least 2 core biopsies. Patients must have had a least one prior standard first line therapy for advanced/metastatic disease with adequate wash-out period since last dose. Patients must have measurable disease per RECIST 1.1 and adequate organ function. At least 4 weeks since major surgery or radiation therapy. ECOG 0-1. Age >= 18 years.

Objectives: Phase I-To determine the recommended phase II dose/schedule and maximum tolerated dose of MG1MA3 alone, AdMA3 alone and in combination. To determine the safety, tolerability, pharmacokinetics (PK) including viral shedding, viral delivery and replication in the tumour cells and anti-tumour activity. Phase II-To assess the anti-tumour activity as evidenced by response rates and further explore the safety profile, PK, cellular and immune response, changes in tumour biomarkers and evaluate overall survival, time to progression by tumour type.

NCT Registration ID (from clinicaltrials.gov): NCT02285816
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 31, 2014

Chair: (Canada) Dr. Derek Jonker, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70168


Open to Accrual
I217 (TOPAZ)A Phase I and Enrichment Study of Low-Dose Metronomic Topotecan and Pazopanib in Pediatric Patients with Recurrent or Refractory Solid Tumours Including CNS Tumours.
A Phase I and Enrichment Study of Low-Dose Metronomic Topotecan and Pazopanib in Pediatric Patients with Recurrent or Refractory Solid Tumours Including CNS Tumours.

Complexity Level: 1

Eligibility: Part 1: Patients must have recurrent or refractory solid tumours, excluding CNS tumours tumours. Part 2: Patients must have neuroblastoma or rhabdomyosarcoma. All patients must have histologic verification of malignancy, adequate bone marrow, renal, cardiac and liver function, measurable or evaluable disease and must meet all other eligibility criteria as defined in Protocol Section 4.

Objectives: Primary Objective: To determine the recommended phase II dose and maximum tolerated dose of LDM topotecan in combination with pazopanib. Secondary Objectives: Anti-tumour activity in solid tumours and specifically in neuroblastoma and rhabdomyosarcoma. Characterize the pharmacokinetic profile as well as drug-drug interactions, and assess the anti-angiogenic activity.

NCT Registration ID (from clinicaltrials.gov): NCT02303028
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: November 03, 2014

Chair: (Canada) Dr. Jim Whitlock, Hospital for Sick Children, (416) 813-8885


Open to Accrual
I222A Phase I/II Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme
A Phase I/II Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme

Complexity Level: 1

Eligibility: Histologically confirmed glioblastoma multiforme that is recurrent after primary treatment, phase II must have measurable disease according to RANO criteria. ECOG 0-1. Radiation completed >= 4 weeks prior registration; surgery within 21 days (excluding resection). No clinically significant cardiac disease in last 12 months such as (coronary artery bypass graft, angioplasty, vascular stent, MI, congestive heart failure NYHA Grade 2, ventricular arrhythmias requiring continuous therapy, uncontrolled arrhythmias including atrial fibrillation, hemorrhagic or thrombotic stroke). No hepatitis B, hepatitis C, HIV or a prior history of tuberculosis, or diabetes type I or uncontrolled type II. No interstitial lung disease. No GI disease, meningeal or extracranial GBM involvement. No known QT/QTc-prolonging drugs. Stable or decreasing dose of corticosteroids. No enzyme inducing anticonvulsants. No medications that are metabolized by CYP3A4/5 5 and CYP2C8, Pgp (MDR1) and BCRP

Objectives: Primary:To determine the recommended phase II dose (RP2D) of AZD2014 in patients receiving standard temozolomide treatment. To estimate the 6 month PFS rate in patients receiving AZD2014 in addition to their standard temozolomide treatment Secondary:To evaluate the plasma levels of AZD2014 alone at the time of resection. To assess the safety and toxicity profile of AZD2014 in patients receiving standard temozolomide treatment. To evaluate potential biomarkers such as PTEN, PI3KCA and other mutations, as well as evidence of pharmacodynamic effects in resected and archival tumour tissue.

NCT Registration ID (from clinicaltrials.gov): NCT02619864
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: January 13, 2016

Chair: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277


Open to Accrual
I223A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer
A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer

Complexity Level: 1

Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients will be pre-screened for CCDN1 amplification and RB1 status. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed. Potent/strong CYP3A inhibitors/inducers not allowed.

Objectives: PRIMARY - To assess the clinical benefit rate (CBR) of palbociclib in patients with metastatic, castration-resistant prostate cancer (mCRPC). SECONDARY - (1) To determine the effect of palbociclib on PSA decline and time to PSA progression; (2) To determine objective response as determined by RECIST 1.1 criteria; (3) To evaluate the safety and toxicity profile of palbociclib in mCRPC patients. EXPLORATORY - (1) To determine whether CCND1 gain/amplification in plasma cell-free DNA (cfDNA) (+/-RB1 wild type) is predictive of CBR to palbociclib; (2) To evaluate gene copy number variation and mutation profile of cfDNA in patients with mCRPC before and after treatment with palbociclib; (3) To identify potential predictive and prognostic blood-based RNA markers.

NCT Registration ID (from clinicaltrials.gov): NCT02905318
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: February 09, 2017

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Open to Accrual
I224A Phase II Study of Concurrent Dabrafenib and Trametinib with Stereotactic Radiation in the Management of Patients with BRAF Mutation-Positive Malignant Melanoma and Brain Metastases
A Phase II Study of Concurrent Dabrafenib and Trametinib with Stereotactic Radiation in the Management of Patients with BRAF Mutation-Positive Malignant Melanoma and Brain Metastases

Complexity Level: 2

Eligibility: Histologically confirmed melanoma metastatic to brain and determined to be BRAF V600 mutation-positive. Presence of measurable disease (with at least one measurable CNS lesion per RECIST 1.1). Presence of 1-10 brain metastases as confirmed on a thin slice axial T1 post-gadolinium MRI sequence. Maximum diameter of a single brain lesion should be <=4 cm. All CNS metastases amenable to single fraction SRS and/or fractionated SRS. ECOG 0-1. No prior treatment with a BRAF inhibitor or MEK inhibitor. No history of malignancy with confirmed activating RAS mutation at any time. No history of HEP B or HEP C virus and no history of interstitial lung disease or active pneumonitis. No prior whole brain radiation or brainstem metastases. No contraindications to MRI and/or Gadolinium contrast or stereotactic brain radiation therapy. No history or current evidence/risk of retinal vein occlusion or central serous retinopathy.

Objectives: Primary Objective: To determine intracranial objective response rate; Secondary objectives: extra-cranial objective response rate and overall ORR; duration of response; intracranial and overall progression free survival; overall survival and to evaluate the safety and tolerability of the regimen using CTCAE v. 4.

NCT Registration ID (from clinicaltrials.gov): NCT02974803
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: November 23, 2016

Chair: (Canada) Dr. Arjun Sahgal, Odette Cancer Centre, (416) 480-4834, (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Open to Accrual
I225A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker
A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker

Complexity Level: 2

Eligibility: Histologically confirmed melanoma that is recurrent/metastatic and not amenable to potentially curative surgery. Clinically and/or radiologically documented disease. ECOG 0-1. No prior systemic therapy for metatatic melanoma. No known history of HIV. Patients with active autoimmune disease that requires systemic steroids or immunosuppressive agents are not eligible. Patients with a history of malignancy within 5 years prior to first study drug administration are not eligible. Patients with an allergy to iodinated contrast media used for CT and patients with known history of active TB are not eligible.

Objectives: Primary Objective: to determine if tumour texture measures derived from CT correlates with response. Secondary Objectives: to determine if tumour texture measures derived from CT correlated with time to disease progression; to assess duration of response; to assess overall response rate; to assess overall survival; to compare QALY between pembrolizumab and dacarbazine; to compare QALY between pembrolizumab and ipilimumab; toxicity using CTCAE v4.

NCT Registration ID (from clinicaltrials.gov): NCT02740920
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: May 12, 2016

Chair: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Open to Accrual
I227A Phase II Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma
A Phase II Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma

Complexity Level: 1

Eligibility: Patients must have histologically confirmed unresectable advanced and/or metastatic malignant pleural mesothelioma with available tumour block. No prior chemotherapy for advanced/metastatic disease. Prior (neo) adjuvant cisplatin-based systemic chemotherapy allowed if last dose > 12 months before registration. No prior targeted small molecule therapy, immunotherapies and viral therapies, biologic therapies and angiogenesis inhibitors for advanced/metastatic disease, or any prior immunotherapy for any stage of disease. Prior radiation therapy is permitted (< 30% BM), measurable disease outside the previously irradiated area is required. No diagnosis of immunodeficiency or is receiving systemic steroid therapy (doses > 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment. No active autoimmune disease requiring systemic treatment < 3 years. No live attenuated vaccines within 30 days.

Objectives: Primary - To evaluate whether pembrolizumab, alone or given to patients receiving standard chemotherapy, improves progression free survival in malignant pleural mesothelioma (MPM) compared to standard chemotherapy. Secondary - To evaluate the tolerability of pembrolizumab, alone or given to patients receiving standard chemotherapy; To assess antitumour activity of pembrolizumab, alone or given to patients receiving standard chemotherapy including response rate and overall survival; To evaluate quality of life effects of pembrolizumab, alone or given to patients receiving standard chemotherapy. Exploratory - To explore the predictive and prognostic value of PD-L1 expression and presence of T cell subsets within the tumour microenvironment and other exploratory blood based biomarkers.

NCT Registration ID (from clinicaltrials.gov): NCT02784171
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 07, 2016

Chair: (Italy) Dr. Francesco Perrone, National Cancer Institute of Naples, (81) 590-3571, (Canada) Dr. Quincy Chu, Cross Cancer Institute, (780) 432-8248


Open to Accrual
I228A Phase II Study of Durvalumab and Tremelimumab in Patients with Advanced Rare Tumours
A Phase II Study of Durvalumab and Tremelimumab in Patients with Advanced Rare Tumours

Complexity Level: 2

Eligibility: Clinically and/or radiologically documented disease, with at least one measurable lesion as defined by RECIST 1.1; >=16 years of age; ECOG 0 or 1; no limit on number of prior chemo; No therapy with PD-1/PD-L1 or CTLA-4 inhibitors. No prior autoimmune or inflammatory disorders ie inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome , etc., within the past 3 years prior to the start of treatment. No history of primary immunodeficiency, allogenic organ transplant that requires therapeutic use of IO agents within 28 days. No attenuated vaccination administered within 30 days. No untreated symptomatic brain mets or in whom radiation or surgery is indicated. NO pts with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.

Objectives: To evaluate the objective response rate of the combination of durvalumab and tremelimumab given by IV every 4 weeks in patients with rare tumours. To explore the correlation between anti-tumour activity and PD-L1 expression, presence of tumour infiltrating lymphocytes (TILs) and T cell subsets within the tumour. To explore the correlation between anti-tumour activity and genomic alterations in tumour. To assess the consistency of histopathological diagnosis of rare tumours through central review of pathology specimens. To explore the correlation between anti-tumour activity and toxicity with blood based biomarkers. To evaluate the tolerability and safety of durvalumab and tremelimumab combination. To evaluate the effect of durvalumab and tremelimumab combination including time to progression, progression free survival and response duration.

NCT Registration ID (from clinicaltrials.gov): NCT02879162
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 19, 2016

Chair: (Canada) Dr. Abha Gupta, Hospital for Sick Children, (416) 946-2252


Open to Accrual
I231A Phase I/II Study of CX5461
A Phase I/II Study of CX5461

Complexity Level: 1

Eligibility: All patients: Age >=18 years. ECOG 0, 1, or 2. Must have an available tissue block. Adequate organ function. Patients must not have known photosensitivity disorders, and must agree to use adequate sun protection and avoid tanning booths. No active infections or untreated/uncontrolled cardiovascular conditions. Phase I: Patients with histologically and/or cytologically confirmed solid malignancy. No limit to the number of prior cytotoxic or other systemic therapy regimens. Phase II: Patients must have triple negative breast cancer or must have BRCA1/2 or HRD germline or somatic aberrations (known, or documented during pre-enrolment screening). Must provide consent for a whole blood sample. At least 6 patients in each cohort must provide consent for a tumour and skin biopsy prior to and on treatment. Must have received at least one but no more than 3 prior cytotoxic therapy regimens. No limit to the number of prior other systemic therapy regimens, but prior PARP inhibtors not allowed.

Objectives: Phase I: Primary - To determine the recommended phase II dose (RP2D) and schedule of CX5461 in patients with solid tumours. Secondary - To establish the safety and tolerability of CX5461 given intravenously to patients with solid tumours; To determine the pharmacokinetics of CX5461 given intravenously in patients with solid tumours. Exploratory - To explore the relationship between germline HRD aberrations and outcomes of CX5461. Phase II: Primary - To evaluate anti-tumour activity assessed by response rate (RR) in each cohort. Secondary - To estimate the progression free survival (PFS) rate at 6 months in each cohort; To assess the safety and toxicity profile of CX5461. Exploratory - To evaluate predictive biomarkers of response to CX5461; To evaluate pharmacodynamic biomarkers of response to CX5461 using ctDNA (all patients) and paired biopsies (selected patients); To explore the relationship between germline HRD aberrations and outcomes of CX5461.

NCT Registration ID (from clinicaltrials.gov): NCT02719977
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: May 16, 2016

Chair: (Canada) Dr. John Hilton, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70179, (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Open to Accrual
I232A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer
A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer

Complexity Level: 2

Eligibility: Patients with histologically confirmed adenocarcinoma of the prostate that is castrate resistant. Must have disease progression either PSA, objective or both as well as surgical or medical castration with testosterone levels <50mg/dL. An available tissue block from primary or metastatic tumour as well as accessible disease suitable for fresh biopsy and consent to biopsy prior to treatment is required. Patients must have measurable disease per RECIST 1.1. Patients may have received prior treatment with docetaxel chemotherapy, tyrosine kinase or other targeted agents. Failure/progression on abiraterone and/or enzalutamide is required. Antiandrogens must have been discontinued for < 4 weeks prior to study entry (6 weeks for bicalutamide). No prior immunotherapy or vaccines, treatment with oncolytics viruses is permissible. No prior history of immunodeficiency, or use or immunosuppressive agents within 28 days of randomization.

Objectives: Primary - To determine the objective response rate (RECIST 1.1 and irRECIST) in patients with metastatic castration resistant prostate cancer (mCRPC) treated with durvalumab alone or in combination with tremelimumab. Secondary - To determine the prostate-specific antigen (PSA) response rate as time to PSA progression; To evaluate time to objective disease progression; To evaluate the toxicity and tolerability of durvalumab alone or in combination with tremelimumab. Exploratory - To explore the utility of tissue and blood based biomarkers to select patients for treatment with durvalumab alone or in combination with tremelimumab.

NCT Registration ID (from clinicaltrials.gov): NCT02788773
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: On Hold
Activation Date: August 18, 2016

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261, (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


On Hold
I206A Phase II Study of Sunitinib or Temsirolimus in Patients with Advanced Rare Tumours.
A Phase II Study of Sunitinib or Temsirolimus in Patients with Advanced Rare Tumours.

Complexity Level: 2

Eligibility: Patients with recurrent, unresectable, locally advanced or metastatic rare tumours: vascular sarcomas (non-pediatric); clear cell carcinomas of ovary, endometrium; medullary thyroid carcinoma; non-pancreatic neuroendocrine tumours: pheochromocytoma, paragangliomas; adrenocortical carcinoma; thymic carcinoma; fibrolamellar hepatocellular carcinoma; rare tumours with somatic mutations in VEGFR, PDGFR, KIT, RET; rare tumours arising from known/suspected germline mutations in PTEN, TS, LKB1, NF1/2. Unidimensionally measurable disease. Archival tissue or fresh biopsy required at study entry. No limit on prior chemotherapy or radiation therapy, although no prior treatment with mTOR inhibitor (for temsirolimus) or VEGFR, PDGFR, RET or KIT inhibitor (for sunitinib) permitted. No uncontrolled hypertension, therapeutic doses of coumadin-derivative anticoagulants, or certain CYP3A4 inhibitors/inducers permitted on sunitinib arm.

Objectives: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 weeks every 6 weeks and temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent rare tumours. To assess the adverse events, time to progression and response duration of sunitinib orally and temsirolimus given IV weekly in patients with rare tumours. To assess time to first and second progression for patients who receive sunitinib and temsirolimus in sequence. To explore the relationship between genetic alterations in the genome in archival and/or fresh tumour tissue and blood samples from patients on this trial and their objective response to therapy. To assess the consistency of diagnosis of rare tumours through central review of pathology specimens.

NCT Registration ID (from clinicaltrials.gov): NCT01396408
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: July 14, 2011 Closing Date: February 05, 2015

Chair: (Canada) Dr. Hal Hirte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Closed to Accrual
I208Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination with Panitumumab in Patients with Metastatic or Advanced RAS-Wild Type Colorectal Cancer.
Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination with Panitumumab in Patients with Metastatic or Advanced RAS-Wild Type Colorectal Cancer.

Complexity Level: 1

Eligibility: Patients with histologic proof of a primary colorectal cancer which is recurrent or metastatic. Tumour must be K-Ras wild type by means of mutation analysis and patient must have a representative sample of tumour tissue available. Patient must have failed, or have been unable to receive prior irinotecan, oxaliplatin and thymidylate synthase inhibitor therapy. Phase I-patients may have measureable or non-measurable disease. Phase II-patients must have measureable disease. At least 4 weeks since major surgery, chemotherapy, investigational agent or radiation therapy. ECOG 0-2. Age > 18 years.

Objectives: Phase I-To determine the recommended phase II dose of BKM120 in combination with standard panitumumab therapy and determine the safety, tolerability, toxicity profile and dose limiting toxicities. Phase II-To assess the anti-tumour activity as evidenced by response rates and early progression and investigate the correlation, if any, between response and molecular biomarkers in archival FFPE tumour.

NCT Registration ID (from clinicaltrials.gov): NCT01591421
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: May 01, 2012 Closing Date: July 14, 2015

Chair: (Canada) Dr. Derek Jonker, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70168


Closed to Accrual
I210A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer.
A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer.

Complexity Level: 2

Eligibility: Patients with a histological diagnosis of metastatic colorectal adenocarcinoma. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. No prior chemotherapy for metastatic disease. Prior adjuvant fluropyrimidine based therapy is permitted >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function. No neuropathy > grade1

Objectives: 1. To evaluate the effect of reolysin in combination with standard FOLFOX6 chemotherapy of the progression free survival of patients with advanced or metastatic colorectal cancer. 2a. To determine the tolerability and toxicity of reolysin and FOLFOX6/Bevacizumab when given in combination. 2b. To investigate additional potential measures of efficacy including:change in CEA levels; objective response rate; evaluate the effect of both treatments on overall survival (OS) 2c.To explore potential molecular factors that may be prognostic or predictive of response by assessment of archival tumour tissue and serial blood samples 2d.To explore the Quality of Life (as measured by the EORTC QLQC30)

NCT Registration ID (from clinicaltrials.gov): NCT01622543
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: June 11, 2012 Closing Date: February 12, 2015

Chair: (Canada) Dr. Derek Jonker, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70168, (Canada) Dr. Patricia Tang, Tom Baker Cancer Centre, (403) 521-3490


Closed to Accrual
I211A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.
A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.

Complexity Level: 2

Eligibility: Patients with a histological or cytological diagnosis of non small cell lung cancer, that is advanced and/or metastatic, for which systemic treatment with docetaxel or pemetrexed is indicated. Tumour block available. Patients must have measureable disease as defined by RECIST 1.1. Must have received one prior regimen of pallative first line chemotherapy (must be platinum containing combination unless patient >70 years), which may not have contained docetaxel. Patients who have had concurrent platinum based chemoradiotherapy for stage 3 disease and have relapsed within 1 year of treatment may be considered to have had one prior platinum containing regimen. Prior pemetrexed first line but not maintenance therapy is permissible and prior adjuvant chemotherapy is permitted if completed at least one year prior to relapse/recurrance. ECOG 0 or 1. No neuropathy >=2.

Objectives: Primary Objective: To evaluate the effect of reolysin in combination with either docetaxel or pemetrexed on the progression free survival of patients with advanced or metastatic non small cell lung cancer. Secondary Objectives: a) To determine the tolerability and toxicity of reolysin and docetaxel or pemetrexed when given in combination. b) To investigate additional potential measures of efficacy including: progression at 3 months, objective response rate and overall survival. c) To explore potential molecular factors predictive of response by assessment of archival tumour tissue and serial blood samples, including KRAS and EGFR status.

NCT Registration ID (from clinicaltrials.gov): NCT01708993
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: October 15, 2012 Closing Date: August 06, 2015

Chair: (Canada) Dr. Donald G. Morris, Tom Baker Cancer Centre, (403) 521-3347


Closed to Accrual
I213A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer
A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer

Complexity Level: 2

Eligibility: Patients with histoligical/cytological diagnosis of metastatic breast cancer, that is advanced and/or metastatic, with no curative therapy and for which systemic therapy is indicated. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. Patients must have received at least one prior chemotherapy regimen for advanced or metastatic disease, unless they have relapsed within 6 months of completion of adjuvant chemotherapy or they have received taxane and/or anthracycline containing adjuvant chemotherapy. ECOG 0-2. No neuropathy > grade 1.

Objectives: Primary Objective: To evaluate the effect of reolysin in combination with standard paclitaxel chemotherapy on the progression free survival of patients with advanced or metastatic breast cancer Secondary Objectives: a) to determine the tolerability and toxicity of reolysin and paclitaxel when given in combination. b) to investigate additional potential measures of efficacy including: objective response rate, overall survival, CTC counts c) to explore potential molecular factors predictive of response by assessment of archival tumour tissue and CTCs, including EGFR and KRAS status.

NCT Registration ID (from clinicaltrials.gov): NCT01656538
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: July 30, 2012 Closing Date: April 20, 2016

Chair: (Canada) Dr. Susan Ellard, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 686657, (Canada) Dr. Vanessa Bernstein, BCCA - Vancouver Island Centre, (250) 519-5571


Closed to Accrual
I215A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.
A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.

Complexity Level: 1

Eligibility: Patients with histologic and/or cytologic confirmed non-small cell lung cancer that is metastatic or unresectable and for which standard curative measures do not exist. Patients accrued to the pemetrexed single agent cohort as well as those accrued to the RP2D expansion cohorts must have documented KRAS mutation, as well as at least one site of disease which is unidimensionally measurable. Patient must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour). At least 14 days since major surgery, 4 weeks since radiation therapy. ECOG 0-1. Age > 18 years. No prior MEK inhibitors or any other tyrosine kinase inhibitor.

Objectives: Primary Objective: To determine the recommended phase II dose (RP2D) and safety profile of selumetinib in patients with advanced/metastatic NSCLC in combination with: pemetrexed; pemetrexed and cisplatin; paclitaxel and carboplatin. Secondary Objectives: 1) to obtain pharmacokinetic (PK) profiles of selumetinib when given daily continuously in combination with chemotherapy; 2) to explore gene expression signatures/profiles and/or KRAS codon subtypes in tumour and/or tumour derived material that may influence response; the use of plasma as a potential source of circulating free tumour DNA (cfDNA) for the analysis of KRAS mutation status; and serum exploratory markers that may predict response to selumetinib; 3) preliminary assessment of efficacy in all patients and in an expansion cohort of up to 10 patients with KRAS positive NSCLC.

NCT Registration ID (from clinicaltrials.gov): NCT01783197
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: January 30, 2013 Closing Date: October 16, 2015

Chair: (Canada) Dr. Garth Nicholas, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70178, (Canada) Dr. John Goffin, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Closed to Accrual
I216Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia
Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia

Complexity Level: 2

Eligibility: Patients with previously documented CLL that is recurrent or relapsed after previous therapy and that requires treatment. Patient must have at least one of the following: lymphocyte count >or= 10 x 10/9/L OR at least one pathologically enlarged lymph node (>or= 2 x 2 cm) by CT scan. Patients must have received at least 1 prior systemic treatment regimen (single agent or combination therapy) and recovered from all reversible toxicity related to prior chemotherapy and have adequate washout period. ECOG 0-2. At least 14 days since major surgery and 21 days since prior radiation therapy.

Objectives: To determine the overall response rate (complete + partial response). To evaluate the safety and tolerability of buparlisib. To evaluate additional measures of efficacy including duration of response rate and progression free survival. To explore potential molecular factors which may be prognostic or predictive of response or of relapse including: correlation between clinical response and MTT assay in B-CLL exposed ex-vivo to buparlisib; correlation between response to buparlisib and western blot and flow cytometry analysis of key proteins involved in the PI3K pathway; identification of mechanisms of resistance among patients who relapse after therapy with buparlisib; to prospectively validate a survival prediction scale.

NCT Registration ID (from clinicaltrials.gov): NCT02340780
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: January 30, 2015 Closing Date: January 24, 2017

Chair: (Canada) Dr. Sarit Assouline, The Jewish General Hospital, (514) 340-8207


Closed to Accrual
I218A Study of Vinblastine and Temsirolimus in Pediatric Patients with Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours
A Study of Vinblastine and Temsirolimus in Pediatric Patients with Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours

Complexity Level: 1

Eligibility: Pediatric patients (age >= 1 year and <=18 years) with histologically confirmed, relapsed/refractory solid tumour, CNS/localized brainstem tumour or Lymphoma (Phase II - low-grade glioma). Patients must have had a least one prior treatment regimen and have adequate washout. Prior therapy with vinblastine and mTOR inhibitors (e.g. temsirolimus or sirolimus) permitted. Prior surgery and radiation permitted provided adequate time has elapsed form last dose. Adequate organ function. No untreated brain metastases, untreated spinal cord compression or meningeal metastases for patients with lymphoma or solid tumours except primary CNS tumours.

Objectives: PRIMARY - To determine the recommended phase II dose (RP2D) of the combination of vinblastine and temsirolimus (administered as a weekly intravenous dose) in children with recurrent or refractory solid tumours including central nervous system (CNS) tumours and lymphoma and to describe the associated toxicities in children. SECONDARY - (1) To assess the anti-tumour activity of vinblastine in combination with temsirolimus in pediatric solid tumours; (2) To characterize the pharmacokinetics of temsirolimus in whole blood (including its principal metabolite sirolimus) when administered in combination with vinblastine; (3) To assess the pharmacodynamics of this regimen by evaluating change in plasma cytokines and angiogenic factors (CAF) and mTOR inhibition in peripheral mononuclear cells as a biomarker of target inhibition.

NCT Registration ID (from clinicaltrials.gov): NCT02343718
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: June 02, 2015 Closing Date: March 31, 2017

Chair: (Canada) Dr. Rebecca Deyell, Children's & Women's Health Centre of BC Branch, (604) 875-2345 Ext. 4815


Closed to Accrual
I219A Randomized Phase II Trial of Selumetinib in Patients Receiving Standard Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous Non-Small Cell Lung Cancer
A Randomized Phase II Trial of Selumetinib in Patients Receiving Standard Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous Non-Small Cell Lung Cancer

Complexity Level: 2

Eligibility: Patients with histologically and/or cytologically confirmed stage IIIB/IV non-squamous, KRAS wildtype or unknown, NSCLC that is metastatic or unresectable and for which standard curative measures do not exist. All patients must have formalin fixed paraffin embedded tissue block available for correlative studies. Must have at least one site of disease that is unidimensionally measurable. ECOG 0-1. No prior MEK inhibitors or tyrosine kinase inhibitor (including EGFR inhibitors of any kind). Prior adjuvant platinum-based chemotherapy or combined chemoradiation with curative intent is permissible if completed > 1 yr prior to enrolment. No prior cytotoxic chemotherapy for advanced/metastatic disease. No significant cardiac disease or gastrointestinal disease. No untreated brain or meningeal metastases (untreated or treated). No potent inhibitors/inducers of CYP3A4/5,CYP2C19/CYP1A2. No central serous retinopathy, retinal vein occlusion, high intraocular pressure or uncontrolled glaucoma.

Objectives: Primary Objective: To determine the efficacy, as determined by objective response rate, of selumetinib (intermittent or continuous) in patients with NSCLC not known to have KRAS mutation receiving standard pemetrexed and cisplatin chemotherapy compared to chemotherapy alone. Secondary Objectives: To assess the tolerability of selumetinib in patients receiving pemetrexed and cisplatin, to explore the progression free survival of patients receiving selumetinib with pemetrexed and cisplatin to those receiving pemetrexed and cisplatin or carboplatin alone and to explore whether KRAS mutation, other common mutations, or tumour based molecular signatures are predictive of selumetinib effect.

NCT Registration ID (from clinicaltrials.gov): NCT02337530
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: February 05, 2015 Closing Date: May 08, 2017

Chair: (Canada) Dr. Barbara Lynn Melosky, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2017, (Canada) Dr. Penelope A. Bradbury, University Health Network, (416) 946-4501 Ext. 3544


Closed to Accrual
I221A Dose-Ranging Study of IPH2201 in Patients with Gynecologic Malignancies
A Dose-Ranging Study of IPH2201 in Patients with Gynecologic Malignancies

Complexity Level: 1

Eligibility: Patients with histologically and/or cytologically confirmed high-grade serous ovarian/fallopian tube or peritoneal carcinoma. Patients must have received prior cytotoxic chemotherapy (at least one regimen must have been platinum-containing) and may be either platinum sensitive or platinum resistant. Patients must have measurable disease per RECIST 1.1 and adequate organ function. Age >=18 years. ECOG 0, 1, or 2. Must have an available formalin fixed paraffin embedded tissue block from primary or metastatic tumour. For Part 2, must be willing to undergo a tumour biopsy prior to registration. Prior surgery and radiation permitted provided adequate time has elapsed form last dose. No active immune-mediated diseases including known HIV infection or hepatitis B/C. No systemic corticosteroid therapy at doses higher than 5 mg/day.

Objectives: PRIMARY - To confirm the recommended phase II dose (RP2D) of single agent IPH2201 in patients with advanced/metastatic/recurrent platinum sensitive or resistant high-grade serous carcinoma (HGSC) of ovarian, fallopian tube or peritoneal origin. SECONDARY - (1) To characterize the pharmacokinetics of IPH2201 when administered as a single agent; (2) To assess the pharmacodynamic effects of single agent IPH2201; (3) To assess the safety and toxicity profile of single agent IPH2201; (4) To explore the efficacy of IPH2201 in platinum resistant or sensitive HGSC; (5) To characterize the immunogenicity of IPH2201 when administered as a single agent.

NCT Registration ID (from clinicaltrials.gov): NCT02459301
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: August 24, 2015 Closing Date: April 20, 2017

Chair: (Canada) Dr. Anna Tinker, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707, (Canada) Dr. Hal Hirte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Closed to Accrual
I226A Phase IB Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Incurable Solid Malignancies Given with or without Standard Chemotherapy Regimens
A Phase IB Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Incurable Solid Malignancies Given with or without Standard Chemotherapy Regimens

Complexity Level: 1

NCT Registration ID (from clinicaltrials.gov): NCT02537418
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: October 01, 2015 Closing Date: September 06, 2017

Chair: (Canada) Dr. Desiree Hao, Tom Baker Cancer Centre, (403) 521-3706, (Canada) Dr. Rosalyn Anne Juergens, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9711 Ext. 64604


Closed to Accrual
I229A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab
A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab

Complexity Level: 1

Eligibility: Patients with histologically and/or cytologically confirmed HER-2 positive metastatic breast cancer. Must have an available formalin fixed paraffin embedded tissue block from primary or metastatic tumour. Patients enrolled to the RP2D / expansion cohort must have accessible disease suitable for biopsy and have consented to biopsy prior to treatment and at the end of cycle 1 (paired biopsies are recommended in all patients). Patients must have measurable disease per RECIST 1.1 and adequate organ function. Age >=18 years. ECOG 0, 1, or 2. Must have had prior exposure to a taxane, trastuzumab and pertuzumab and preferably also prior exposure to TDM-1 (no limit to number of prior regimens). Prior surgery and radiation permitted provided adequate time has elapsed form last dose. No active or prior autoimmune or inflammatory disorders, or history of primary immunodeficiency. No live attenuated vaccination on treatment or within 30 days of either registration or last dose.

Objectives: PRIMARY - To determine the recommended phase II dose of durvalumab given to patients with advanced/recurrent HER-2 positive metastatic breast cancer (MBC) who are receiving treatment with trastuzumab. SECONDARY - (1) To describe the toxicities of durvalumab in patients receiving trastuzumab; (2) To evaluate the response rate and clinical benefit rate of durvalumab (measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab; (3) To assess PD-L1 expression in paired biopsies pre and post treatment with durvalumab as a marker of response/benefit. EXPLORATORY - (1) To perform whole exome sequencing and RNAseq in paired biopsies (pre and post treatment) to explore biological correlates relative to PD-1/PD-L1 and trastuzumab and durvalumab exposure (minimum of 6 patients with paired biopsies); (2) To collect ctDNA as an exploratory marker; (3) To assess T cell and other immune cell subsets in paired biopsies pre and post treatment.

NCT Registration ID (from clinicaltrials.gov): NCT02649686
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: April 21, 2016 Closing Date: April 20, 2017

Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752


Closed to Accrual
I100NCIC CTG Phase II Combination Trial of Topotecan and Etoposide in Patients with AML
NCIC CTG Phase II Combination Trial of Topotecan and Etoposide in Patients with AML

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 09, 1996 Closing Date: May 13, 1998

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
I101NCIC CTG Phase I Dose Finding Study of RPR 109881A Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumours
NCIC CTG Phase I Dose Finding Study of RPR 109881A Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumours

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 23, 1996 Closing Date: March 13, 1998

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Permanently Closed
I102NCIC CTG Phase II Study of BMS-182751 (JM-216) in Patients With Advanced and/or Recurrent Squamous Cell Carcinoma of the Cervix
NCIC CTG Phase II Study of BMS-182751 (JM-216) in Patients With Advanced and/or Recurrent Squamous Cell Carcinoma of the Cervix

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 27, 1997 Closing Date: February 16, 1999

Chair: (Canada) Dr. Gavin Stuart, University of British Columbia, (604) 822-5767, (Canada) Dr. Marc G. Trudeau, The Medicine Cancer Centre, (403) 529-8817


Permanently Closed
I103NCIC CTG Phase I Study of BCH-4556 Given as a 30 Minute Infusion Every 3 Weeks
NCIC CTG Phase I Study of BCH-4556 Given as a 30 Minute Infusion Every 3 Weeks

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 27, 1997 Closing Date: March 02, 1999

Chair: (Canada) Dr. Karl Belanger, CHUM - Hopital Notre-Dame, (514) 890-8000 Ext. 25381


Permanently Closed
I104NCIC CTG Randomized Phase II Study of Two Schedules of Bryostatin 1 (NSC 339555) in Patients With Advanced Malignant Melanoma
NCIC CTG Randomized Phase II Study of Two Schedules of Bryostatin 1 (NSC 339555) in Patients With Advanced Malignant Melanoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 05, 1997 Closing Date: October 26, 1998

Chair: (Canada) Dr. Karl Belanger, CHUM - Hopital Notre-Dame, (514) 890-8000 Ext. 25381


Permanently Closed
I105NCIC CTG Phase II Study of 776C85 Plus 5FU in Head and Neck Cancer
NCIC CTG Phase II Study of 776C85 Plus 5FU in Head and Neck Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 10, 1997 Closing Date: February 22, 1999

Chair: (Canada) Dr. Meg Knowling, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 672017


Permanently Closed
I106NCIC CTG Phase II Study of Topotecan/Cisplatin/Paclitaxel as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer
NCIC CTG Phase II Study of Topotecan/Cisplatin/Paclitaxel as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 10, 1997 Closing Date: May 07, 1998

Chair: (Canada) Dr. Paul J. Hoskins, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2365


Permanently Closed
I106BPhase II Study of Topotecan/Cisplatin Followed by Paclitaxel/Carboplatin as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer
Phase II Study of Topotecan/Cisplatin Followed by Paclitaxel/Carboplatin as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 27, 1999 Closing Date: December 16, 1999

Chair: (Canada) Dr. Paul J. Hoskins, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2365


Permanently Closed
I107NCIC CTG Phase I Study of BAY 12-9566 in Patients With Advanced Cancer
NCIC CTG Phase I Study of BAY 12-9566 in Patients With Advanced Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 27, 1997 Closing Date: December 10, 1997

Chair: (Canada) Dr. Hal Hirte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495, (Canada) Dr. Rakesh Goel, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70171


Permanently Closed
I108A Phase II Study of Topotecan and Etoposide in Patients With Intermediate Grade Non-Hodgkin's Lymphoma
A Phase II Study of Topotecan and Etoposide in Patients With Intermediate Grade Non-Hodgkin's Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 05, 1997 Closing Date: May 07, 1998

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
I109NCIC CTG Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma
NCIC CTG Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma

NCT Registration ID (from clinicaltrials.gov): NCT00003372
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 08, 1997 Closing Date: April 20, 2000

Chair: (Canada) Dr. Karl Belanger, CHUM - Hopital Notre-Dame, (514) 890-8000 Ext. 25381


Permanently Closed
I11NCIC CTG Phase II Study of TCAR in Lung
NCIC CTG Phase II Study of TCAR in Lung

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 1985 Closing Date: March 01, 1987

Permanently Closed
I110NCIC CTG Phase II Study of Multi-Targeted Anti-Folate (MTA) LY231514 in Combination With Cisplatin in Patients With Advanced Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of Multi-Targeted Anti-Folate (MTA) LY231514 in Combination With Cisplatin in Patients With Advanced Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 15, 1998 Closing Date: June 07, 1999

Chair: (Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4522


Permanently Closed
I111A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer
A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 12, 1998 Closing Date: January 22, 1999

Permanently Closed
I112NCIC CTG Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Locally Advanced or Metastatic Colorectal Cancer
NCIC CTG Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Locally Advanced or Metastatic Colorectal Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 11, 1998 Closing Date: September 29, 1999

Chair: (Canada) Dr. Christine Cripps, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70176


Permanently Closed
I113NCIC CTG Phase I Interaction Study Between BAY 12-9566 and Modulated Dose Intensive Fluorouracil (Arm A) or Doxorubicin (Arm B) in Cancer Patients
NCIC CTG Phase I Interaction Study Between BAY 12-9566 and Modulated Dose Intensive Fluorouracil (Arm A) or Doxorubicin (Arm B) in Cancer Patients

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 10, 1998 Closing Date: September 20, 1999

Chair: (Canada) Dr. Edmond Chouinard, Cambridge Memorial Hospital, (519) 621-2333 Ext. 2594, (Canada) Dr. Rakesh Goel, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70171


Permanently Closed
I114NCIC CTG Phase II Study of Vasopression Receptor Type 1-A Antagonist SR49059 in Patients With Previously Treated Small Cell Lung Cancer
NCIC CTG Phase II Study of Vasopression Receptor Type 1-A Antagonist SR49059 in Patients With Previously Treated Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 05, 1999 Closing Date: October 20, 2000

Permanently Closed
I115A Phase I Study of Aplidine Given as a 1 Hour IV Infusion Daily x 5 Days Every 3 Weeks in Patients with Solid Tumours or Low or Intermediate Grade Non-Hodgkin's Lymphoma Refractory to Standard Curative Therapy
A Phase I Study of Aplidine Given as a 1 Hour IV Infusion Daily x 5 Days Every 3 Weeks in Patients with Solid Tumours or Low or Intermediate Grade Non-Hodgkin's Lymphoma Refractory to Standard Curative Therapy

Eligibility: Histologically or cytologically documented advanced and/or metastatic solid tumours or refractory low/intermediate grade NHL. Prior chemotherapy and radiotherapy permitted. No patients with pre-existing neuropathies permitted.

Objectives: To determine the maximum tolerated dose (MTD) of aplidine given as a 1 hour infusion daily x 5 every 3 weeks. To determine safety, toxicity profile and pharmacokinetics of aplidine given in this schedule. To examine efficacy of aplidine given in this schedule.

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 15, 1999 Closing Date: February 07, 2002

Permanently Closed
I116NCIC CTG Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer
NCIC CTG Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer

NCT Registration ID (from clinicaltrials.gov): NCT00003892
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 01, 1999 Closing Date: May 05, 2000

Chair: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2818


Permanently Closed
I119A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma
A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 16, 1999 Closing Date: March 21, 2000

Permanently Closed
I12NCIC CTG Phase II Study of CBDCA in Ovary
NCIC CTG Phase II Study of CBDCA in Ovary

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 01, 1984 Closing Date: February 21, 1985

Permanently Closed
I120A Phase II Study of Troxacitabine in Patients With Advanced Non-Small Cell Lung Cancer
A Phase II Study of Troxacitabine in Patients With Advanced Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCt
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 16, 1999 Closing Date: May 30, 2000

Chair: (Canada) Dr. Susan Dent, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70167


Permanently Closed
I121A Phase I Study of LY335979 Administered in Combination With Vinorelbine in Patients With Solid Cancers
A Phase I Study of LY335979 Administered in Combination With Vinorelbine in Patients With Solid Cancers

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 01, 1999 Closing Date: November 06, 2000

Permanently Closed
I122A Phase I Study of Oral ZD1839 Given Daily in Patients With Solid Tumours
A Phase I Study of Oral ZD1839 Given Daily in Patients With Solid Tumours

Eligibility: Advanced and/or metastatic solid tumours, expected to have epidermal growth factor receptor (EGFR) mutation/over-expression and tissue accessible for needle biopsy. Prior chemotherapy permissible.

Objectives: To determine the biologically active dose range (BADR) as evidence of target effect in a number of clinical correlative studies and MTD (if BADR is not defined prior to MTD) of oral ZD1839 when given daily. To determine safety/toxicity profile, dose limiting toxicities and pharmacokinetics of oral ZD1839.

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 14, 1999 Closing Date: June 28, 2001

Chair: (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955


Permanently Closed
I123A Phase I Study of NX-211 Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients with Solid Tumours
A Phase I Study of NX-211 Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients with Solid Tumours

NCT Registration ID (from clinicaltrials.gov): NCT00003891
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 25, 1999 Closing Date: June 09, 2000

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Permanently Closed
I124A Phase I Study of MG98 Given as a 21 Day Continuous IV Infusion in Patients With Advanced Cancer
A Phase I Study of MG98 Given as a 21 Day Continuous IV Infusion in Patients With Advanced Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 11, 1999 Closing Date: May 12, 2000

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032, (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911


Permanently Closed
I125A Phase I Study Of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
A Phase I Study Of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

NCT Registration ID (from clinicaltrials.gov): NCT00003890
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 22, 1999 Closing Date: March 08, 2001

Chair: (USA) Dr. Ross Donehower, The Sidney Kimmel Comprehensive, (410) 955-8974


Permanently Closed
I126A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer
A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer

NCT Registration ID (from clinicaltrials.gov): NCT00004251
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 19, 2000 Closing Date: May 16, 2001

Chair: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2818, (Canada) Dr. Anthony Fyles, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-6522


Permanently Closed
I127A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

Eligibility: Histologically or cytologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or with no prior therapy. Pathology must be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility BEFORE patient registration if questionable. Presence of clinically and/or radiologically documented disease. 0-2 prior chemotherapy regimens permitted. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

Objectives: To assess the efficacy of flavopiridol, given as a 3 day bolus every 21 days. To assess the toxicity of flavopiridol when administered on this schedule in the patient group.

NCT Registration ID (from clinicaltrials.gov): NCT00005074
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 24, 2000 Closing Date: October 10, 2001

Chair: (Canada) Dr. Joseph M. Connors, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I128NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy
NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 03, 1999 Closing Date: May 01, 2001

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261


Permanently Closed
I129A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer
A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 14, 2000 Closing Date: March 02, 2001

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Permanently Closed
I13NCIC CTG Phase II Study of N-methylformamide in Glioma
NCIC CTG Phase II Study of N-methylformamide in Glioma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 01, 1984 Closing Date: April 29, 1985

Permanently Closed
I130A Phase I Study of T900607 Given Once Every Three Weeks in Patients With Advanced Refractory Cancer
A Phase I Study of T900607 Given Once Every Three Weeks in Patients With Advanced Refractory Cancer

Eligibility: Patients with advanced refractory cancer. Unidimensionally measurable disease. Prior chemotherapy radiation (< 25 % hematopoietic bone marrow), immunotherapy and surgery permitted.

Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of T900607 when given as a 60 minute infusion every 21 days. To evaluate the safety and dose-limiting toxicities (DLT), determine the pharmacokinetics parameters and pharmacodynamic effects. Document preliminary efficacy information and correlate expression of drug resistance markers with response.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 07, 2000 Closing Date: December 19, 2002

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032, (Canada) Dr. Karl Belanger, CHUM - Hopital Notre-Dame, (514) 890-8000 Ext. 25381


Permanently Closed
I131A Phase I Study of ZD0473 and Docetaxel Given Once Every Three Weeks in Patients With Advanced Refractory Cancer
A Phase I Study of ZD0473 and Docetaxel Given Once Every Three Weeks in Patients With Advanced Refractory Cancer

Eligibility: Histologially documented advanced and/or metastatic solid tumours refractory to standard curative therapy or for which no curative therapy exists. Up to two prior chemotherapy regimens permitted.

Objectives: To determine the maximum tolerated doses and recommended doses of ZD0473 and docetaxel when given in combination to patients with advanced cancer.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 04, 2000 Closing Date: February 08, 2002

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Permanently Closed
I132A Phase II Study of Temozolomide Given in a 7 Days On, 7 Days Off Oral Schedule Every 4 Weeks to Patients with Advanced Breast Cancer
A Phase II Study of Temozolomide Given in a 7 Days On, 7 Days Off Oral Schedule Every 4 Weeks to Patients with Advanced Breast Cancer

Eligibility: Women with histologically documented advanced or metastatic breast cancer. Clinically and/or radiologically assessable disease. Unidimensional measurable disease. Prior adjuvant chemotherapy and/or up to two prior chemotherapy regimens for metastatic disease permitted.

Objectives: To assess the efficacy (measured by objective tumour response) of temozolomide when given in this schedule in this patient population. To determine the duration of response, time to progression and the toxic effects of temozolomide when administered in this fashion.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 01, 2000 Closing Date: September 26, 2001

Chair: (Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, (416) 480-5145


Permanently Closed
I133A Phase I Study of NX211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients With Solid Tumours
A Phase I Study of NX211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients With Solid Tumours

Eligibility: Histologically or cytologically documented advanced and/or metastatic solid tumours with 1 or less prior chemotherapy regimens.

Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of NX211 given in combination with cisplatin on days 1, 2 and 3 every 3 weeks. To describe the toxicity profile, dose limiting toxicities and the pharmacokinetics of NX211 and cisplatin when given in this schedule. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. Objective tumour response will be assessed in those patients with measurable disease in particular for the patients with small cell lung cancer entered at the level of MTD.

NCT Registration ID (from clinicaltrials.gov): NCT00006036
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 22, 2000 Closing Date: November 22, 2001

Chair: (Canada) Dr. Hal Hirte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Permanently Closed
I134A Phase I Study of BAY 38-3441 Given as a Short Infusion Daily For Five Days Every Three Weeks
A Phase I Study of BAY 38-3441 Given as a Short Infusion Daily For Five Days Every Three Weeks

Eligibility: Histologically documented advanced and/or metastatic solid tumours refractory to standard curative therapy or for which no curative therapy exists. Up to two prior chemotherapy regimens permitted.

Objectives: To determine the maximum tolerated dose (MTD) and recommended dose of BAY38-3441 when given as a short daily infusion for five days every three weeks to patients with advanced cancer.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 12, 2000 Closing Date: January 16, 2003

Chair: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911


Permanently Closed
I135A Phase I/II Study Of CPT-11 (Irinotecan), Oxaliplatin and Raltitrexed (COT) in Patients With Advanced Colorectal Cancer
A Phase I/II Study Of CPT-11 (Irinotecan), Oxaliplatin and Raltitrexed (COT) in Patients With Advanced Colorectal Cancer

Eligibility: Histologically documented colon or rectal cancer that is metastatic or locally recurrent.

Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of COT given as intravenous infusions on day 1 every 3 weeks. To determine the toxic effects of COT. To determine the pharmacokinetics IF the toxicity of the combined regimen is not in keeping with the toxicity expected from single or double agent studies. To assess clinical response rates of the combination.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 28, 2000 Closing Date: February 07, 2002

Permanently Closed
I136A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Recurrent Soft Tissue Sarcoma
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Recurrent Soft Tissue Sarcoma

NCT Registration ID (from clinicaltrials.gov): NCT00005974
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 04, 2000 Closing Date: March 06, 2001

Chair: (Canada) Dr. Donald G. Morris, Tom Baker Cancer Centre, (403) 521-3347


Permanently Closed
I137A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma

Eligibility: Patients with malignant melanoma, recurrent and non-curable by surgical or other means. Prior adjuvant immunotherapy permitted. No systemic therapy for relapsed disease (ie, chemotherapy naive).

Objectives: To determine the efficacy and toxicity of flavopiridol given as a one hour IV infusion daily x three days every three weeks in patients with recurrent/metastatic malignant melanoma.

NCT Registration ID (from clinicaltrials.gov): NCT00005971
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 04, 2000 Closing Date: July 13, 2001

Permanently Closed
I138NCIC CTG Randomized Phase II Study of NX211 Given by Two Different Intravenous Schedules in Advanced and/or Recurrent Epithelial Ovarian Cancer
NCIC CTG Randomized Phase II Study of NX211 Given by Two Different Intravenous Schedules in Advanced and/or Recurrent Epithelial Ovarian Cancer

Eligibility: Histologically documented advanced and/or recurrent epithelial ovarian cancer (primary fallopian or peritoneal cancer also eligible). One or two prior regimens of chemotherapy required with at least one regimen containing cisplatin or carboplatin. At least one site unidimensional disease.

Objectives: To evaluate, in parallel, the efficacy of two treatment schedules of NX211 as determined by objective response and tumour marker (CA125) in patients with advanced and/or recurrent ovarian cancer. To evaluate the safety, time to progression, and pharmacokinetics of both treatment schedules.

NCT Registration ID (from clinicaltrials.gov): NCT00010179
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 31, 2000 Closing Date: September 21, 2001

Chair: (UK) Prof. Hilary Calvert, Newcastle General Hospital, (191) 273-1631, (Canada) Dr. Robert N. Grimshaw, QEII Health Sciences Centre, (902) 473-4029


Permanently Closed
I139A Phase II Study of T138067-Sodium in Patients With Malignant Glioma
A Phase II Study of T138067-Sodium in Patients With Malignant Glioma

Eligibility: Histologically proven malignant glioma (glioblastoma multiforme or anaplastic astrocytoma). Recurrent or progressive disease following primary surgery and radiation treatment. Up to ONE prior chemotherapy regimen in the adjuvant setting, no chemotherapy for recurrence. Stable dose of steriod for > 14 days prior to registration.

Objectives: To determine the efficacy and toxicity of T138067-sodium in patients with recurrent malignant glioma when given as a weekly 3-hour infusion. To determine the pharmacokinetics of T138067-sodium in a subset of patients (6) enrolled on this study.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 08, 2000 Closing Date: January 09, 2002

Permanently Closed
I14NCIC CTG Phase II Study of N-methylformamide in Melanoma
NCIC CTG Phase II Study of N-methylformamide in Melanoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 01, 1984 Closing Date: April 29, 1985

Permanently Closed
I140A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer
A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer

Eligibility: Prostate cancer patients with evidence of progression by rising PSA or progressive measurable disease on androgen ablative therapy; PSA > 20 ng/mL; chemo-naive; minimally symptomatic disease.

Objectives: To determine the efficacy, and toxicity of two different doses of ZD1839 (250 mg or 500 mg) in patients with hormone refractory prostate cancer. Objective response where applicable, PSA response and duration of these responses, will be measured.

NCT Registration ID (from clinicaltrials.gov): NCT00025116
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 24, 2001 Closing Date: April 25, 2002

Permanently Closed
I141A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Eligibility: Acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), not requiring urgent cytoreductive therapy. One prior chemotherapy regimen permitted.

Objectives: To determine the maximum tolerated doses (MTD) and the recommended doses (RD) of two different schedules of BAY 43-9006 in patients with AML or MDS. To determine toxic effects, pharmacokinetics, gene expression, target effects and clinical response rates of BAY-43-9006 in this patient population.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 01, 2001 Closing Date: April 01, 2004

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
I142A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma
A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma

Eligibility: Patients with recurrent histologically proven malignant glioma (anaplastic astrocytoma or glioblastoma multiforme). Patients with anaplastic astrocytoma may have had up to ONE prior chemotherapy regimen in the adjuvant setting, but NO chemotherapy for recurrence. Patients with glioblastoma multiforme must be chemotherapy-naive. Bidimensionally measurable enhancing lesions on CT or MRI.

Objectives: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent malignant glioma. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.

NCT Registration ID (from clinicaltrials.gov): NCT00036660
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 10, 2002 Closing Date: December 17, 2002

Chair: (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, (403) 944-1260


Permanently Closed
I143A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma
A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

Eligibility: Patients with recurrent or metastatic renal cell carcinoma. No prior chemotherapy or immunotherapy for advanced/recurrent disease. Clinically and/or radiologically documented unidimensionally measurable disease.

Objectives: To evaluate the efficacy and safety of MG98 when given as a 2-hour IV infusion twice weekly for 3 out or every 4 weeks in patients with advanced and/or metastatic renal cell carcinoma.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 2001 Closing Date: May 10, 2002

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261


Permanently Closed
I144A Phase I Study of Oral LY293111 Given Daily in Combination With Irinotecan in Patients With Solid Tumours
A Phase I Study of Oral LY293111 Given Daily in Combination With Irinotecan in Patients With Solid Tumours

Eligibility: Histologically or cytologically documented evidence of advanced and/or metastatic solid tumours with up to two prior chemotherapy regimens.

Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of the combination of irinotecan and LY293111 when IV irinotecan is given on day 1 every 3 weeks and LY293111 is given orally twice daily from the evening of day 2 onward. To determine the toxic effects of this combination and define the duration and reversibility of these effects. To determine the pharmacokinetics of drug-drug interaction of this combination and to assess the clinical response rates in patients with measurable disease treated with this combination.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 23, 2001 Closing Date: June 29, 2004

Permanently Closed
I145A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma
A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma

Eligibility: Patients with confirmed diagnosis of multiple myeloma with a measurable serum or urine M-component at initial diagnosis. Patients must have relapsed following first or second line oral alkylating therapy or high dose chemotherapy and stem cell transplant. Patients are not eligible if they relapsed during prior treatment, have had > 2 prior chemotherapy regimens or relapsed within 3 months after last treatment.

Objectives: To assess the efficacy of ZD6474 when given orally to patients with relapsed previously treated multiple myeloma. To determine the toxic effects, duration of response, time to progression, and pharmacokinetics profile and characteristics, as well as to examine bone marrow samples in patients with multiple myeloma given ZD6474.

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 02, 2002 Closing Date: April 08, 2004

Chair: (Canada) Dr. Michael J. Kovacs, London Health Sciences Centre, (519) 685-8500 Ext. 52254


Permanently Closed
I146A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer

Eligibility: Histologically proven colorectal cancer, either locally recurrent or metastatic following first-line chemotherapy for recurrent/metastatic disease. Clinically or radiological documented unidimensional measurable disease (RECIST criteria). Must have received one previous chemotherapy regimen for recurrent/metastatic disease. Prior nitrosourea not permitted.

Objectives: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent/metastatic colorectal cancer. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.

NCT Registration ID (from clinicaltrials.gov): NCT00028015
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 30, 2001 Closing Date: August 14, 2003

Chair: (Canada) Dr. Ralph P.W. Wong, CancerCare Manitoba, St. Boniface General Hospital, (204) 235-3044


Permanently Closed
I147Phase I Study of GS7836 in Patients With Advanced Incurable Solid Tumours
Phase I Study of GS7836 in Patients With Advanced Incurable Solid Tumours

Eligibility: Histologically or cytologically documented solid tumour cancer. Clinically or radiologically documented disease. Up to three prior chemotherapy regimens permitted.

Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of GS7836 in patients with solid tumours. To determine the safety, tolerability, toxicity profile, dose limiting toxicities and PK profile of GS7836. To assess the anti-tumour activity of GS7836 in patients with measurable disease.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 28, 2001 Closing Date: February 17, 2004

Chair: (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955, (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911


Permanently Closed
I148A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium
A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium

Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess EGFR status. Patients may have had up to one prior hormonal treatment (adjuvant or metastatic). No prior chemotherapy permitted. No prior EGFR targetting therapy permitted.

Objectives: To assess the efficacy (response rate and duration of stable disease) of OSI-774 given daily to patients with advanced/metastatic carcinoma of the endometrium. To assess toxicity, time to progression and response duration of OSI-774 in this patient population. To correlate objective tumour response with EGFR expression from primary tumour in these patients. To explore patterns of change in markers of EGFR activation in patients that have biopsies (additional investigations).

NCT Registration ID (from clinicaltrials.gov): NCT00030485
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 10, 2002 Closing Date: March 16, 2004

Chair: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2818, (Canada) Dr. Anthony Fyles, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-6522


Permanently Closed
I149A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer
A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer

Eligibility: Patients with histologically documented epithelial ovarian cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess EGFR status. Up to 2 prior chemotherapy regimens with the first regimen containing carboplatin or cisplatin. Patients MUST have responded to platinum based first-line chemotherapy. No prior EGFR targeting therapy permitted.

Objectives: To assess the efficacy (response rate and duration of stable disease) of OSI-774 given daily to patients with advanced ovarian carcinoma who are reveiving carboplatin. To assess toxicity, time to progression and response duration of OSI-774 in this patient population. To correlate objective tumour response with EGFR status from primary tumour in these patients. To explore patterns of change in EGFR markers in patients that have biopsies and/or ascitic taps (additional investigations). To assess CA 125 response in patients with elevated CA 125 levels at study entry.

NCT Registration ID (from clinicaltrials.gov): NCT00030446
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 10, 2002 Closing Date: June 01, 2004

Chair: (Canada) Dr. Hal Hirte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Permanently Closed
I15NCIC CTG Phase II Study of Mitoxantrone in Sarcoma
NCIC CTG Phase II Study of Mitoxantrone in Sarcoma

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 03, 1984 Closing Date: December 09, 1985

Permanently Closed
I150A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

Eligibility: Histologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or no prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. O-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior investigational therapy. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To determine 20S proteasome levels in whole blood and correlate suppression of this marker with toxicity and response to PS-341.

NCT Registration ID (from clinicaltrials.gov): NCT00030875
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 04, 2002 Closing Date: July 28, 2004

Chair: (Canada) Dr. Andrew Belch, Cross Cancer Institute, (780) 432-8757


Permanently Closed
I152 (IND.152)A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia
A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia

Eligibility: Confirmed diagnosis of Waldenstrom's Macroglobulinemia. If newly diagnosed or untreated must have IgM > 20 g/L, if previously treated IgM must be > 5g/L at time of registration. Must be symptomatic. O-2 prior chemotherapy regimens, non-refractory to prior therapy; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray.

NCT Registration ID (from clinicaltrials.gov): NCT00045695
Participation: Limited to invited centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 27, 2002 Closing Date: March 23, 2005

Chair: (Canada) Dr. Christine Chen, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2827


Permanently Closed
I153A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer

Eligibility: Histologically confirmed adenocarcinoma of the prostate. No prior treatment. Must be a potential candidate for radical prostatectomy. Minimum 2 positive biopsies and at least one of the following: clinical stage T3; serum PSA > 10 ng/ml; Gleason score 7-10 or Gleason score 6 and >= 3 positive biopsies

Objectives: To determine the toxicity and define the recommended phase II dose of OGX-011 administered days 1, 3, 5, 8, 15, 22 and 29 intravenously with neoadjuvant hormone therapy prior to radical prostatectomy. To determine the plasma pharmacokinetic profile To determine the tissue concentration of OGX-011 in radical prostatectomy specimens. To measure evidence of effect on clusterin expression in peripheral blood mononuclear cells and clusterin serum levels. To assess the effect of the combined hormone and OGX-011 therapy on com[plete response rates. To attempt to establish correlations between palsma and or prostate concentrations of OGX-011 with patient response or toxicity.

NCT Registration ID (from clinicaltrials.gov): NCT00054106
Participation: Limited to one centre: BCCA-Vancouver
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 06, 2002 Closing Date: May 05, 2004

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I154A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel
A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel

Eligibility: Histologic or cytologic evidence of a solid tumour that has been shown to overexpress clusterin (prostate, renal cell, bladder, breast, ovarian cancers). Must have metastatic or locally recurrent disease that is either refractory to standard curative therapy or for which no curative therapy exists. No limit to the number of previous chemotherapy, hormone therapy for patients enrolled to schedule 'A' but limit of <= 2 prior regimens if registered to schedule 'B'.

Objectives: To determine the toxicity and define the recommneded phase II dose of OGX-011 when given in combination with docetaxel. To determine the pharmacokinetic profile of OGX-011 and weekly docetaxel when administered in combination. To measure evidence of effect on serum clusterin levels and clusterin expression in PBMC and accessible tumours. To document any objective responses.

NCT Registration ID (from clinicaltrials.gov): NCT00471432
Participation: Limited to invited centres only.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 06, 2003 Closing Date: June 28, 2005

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I155A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma
A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

Eligibility: Patients with histologically documented metastatic or locally advanced soft tissue sarcoma that is not curable by other means. Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is permitted.

Objectives: To assess the efficacy & toxicity of perifosine given by mouth for 3 weeks every 4 weeks in patients with untreated, metastatic or locally advanced soft tissue sarcoma. progression rate, and, if responses are observed, response duration.

NCT Registration ID (from clinicaltrials.gov): NCT00053794
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 15, 2003 Closing Date: August 10, 2004

Chair: (Canada) Dr. Meg Knowling, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 672017


Permanently Closed
I156A Phase II Study of Perifosine in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
A Phase II Study of Perifosine in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma

Eligibility: Patients with histologically documented malignant melanoma, with metastatic or recurrent disease not curable by other means. Patients may have had prior adjuvant immunotherapy but must NOT have received ANY prior chemotherapy. Disease must be clinically and/or radiologically documented and at least one site of disease must be unidimensionally measurable.

Objectives: To assess the efficacy and toxicity of Perifosine given by mouth for 3 weeks every 4 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

NCT Registration ID (from clinicaltrials.gov): NCT00053781
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 16, 2003 Closing Date: April 26, 2004

Permanently Closed
I157 (PHL002)A Phase I/II Study of OSI-774 in Combination With Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (Princess Margaret Hospital Phase II Consortium - PHL 002)
A Phase I/II Study of OSI-774 in Combination With Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (Princess Margaret Hospital Phase II Consortium - PHL 002)

Eligibility: Recurrent, unresectable and/or metastatic squamous cell cancer of the head and neck; no prior chemotherapy for recurrent/metastatic disease; unidimensionally measurable disease; patients must have completed any prior radiotherapy > 4 weeks before study entry

Objectives: To determine the objective response rate of OSI-774 in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck.

NCT Registration ID (from clinicaltrials.gov): NCT00030576
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 10, 2003 Closing Date: September 22, 2004

Chair: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911


Permanently Closed
I16NCIC CTG Phase II Study of Acivicin in Lymphoma
NCIC CTG Phase II Study of Acivicin in Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 12, 1984 Closing Date: October 30, 1987

Permanently Closed
I160A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer
A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

Complexity Level: 2

Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of CCI-779 activation. Group A patients may have had up to one prior hormonal treatment (adjuvant or metastatic) with no prior chemotherapy permitted. Group B patients may have had an unlimited number of prior hormonal treatments (adjuvant or metastatic) and must have had one cycle of cytotoxic chemotherapy.

Objectives: To assess the efficacy (response rate and duration of stable disease) of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour). To explore the relatinoship between objective tumour response with other molecular measures in diagnostic tumour tissue.

NCT Registration ID (from clinicaltrials.gov): NCT00072176
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 14, 2004 Closing Date: June 15, 2007

Chair: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2818, (Canada) Dr. Laurie Elit, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 389-5688


Permanently Closed
I161A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma
A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

Eligibility: Patients with histologically or cytologically documented renal cell cancer that is locally recurrent or metastatic. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. No prior systemic chemotherapy regimens. Previous interferon permitted > 3 months prior to study entry. No immunotherapy for advanced/recurrent disease. No gene therapy. Known HIV-positive patients are not permitted nor patients with known glucose-6 phosphate dehydrogenase deficiency.

Objectives: To assess the efficacy (objective response rate) of Triapine given as a 2-hour IV infusion for 4 consecutive days every other week to patients with recurrent/ metastatic renal cell cancer who have received no prior systemic therapy for recurrence. To determine adverse events and tolerability of Triapine in this patient population. To describe time to disease progression and overall patient survival.

NCT Registration ID (from clinicaltrials.gov): NCT00075660
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 16, 2004 Closing Date: April 05, 2005

Chair: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2399


Permanently Closed
I162A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma
A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma

Eligibility: Patients with newly diagnosed (no prior chemotherapy permitted) or recurrent (only one prior adjuvant chemo regimen permitted), glioblastoma multiforme (GBM). Bidimensionally measurable disease. Stable dose of steroids. Paraffin embedded tumour sample available for study.

Objectives: To assess the toxicity, pharmacokinetics, efficacy, MTD, and RPII dose(s) of RAD001C when given in combination with standard dose of Temozolomide in patients with GBM. Patients receiving enzyme inducing anti-epileptic drugs (EIAEDs) and those not receiving EIAEDs will be studied separately.

NCT Registration ID (from clinicaltrials.gov): NCT00387400
Participation: Participation in this study is restricted to invited centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 25, 2006 Closing Date: June 01, 2009

Chair: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2277


Permanently Closed
I163A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer
A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer

Eligibility: Patients with recurrent or metastatic breast cancer incurable by other means. Prior adjuvant as well as up to one prior regimen for recurrent/metastatic disease is permitted. Measurable disease. Paraffin embedded tumour sample available for study.

Objectives: To evaluate, in parallel, the anti-tumour efficacy of two oral treatment schedules of RAD001C. To assess the adverse events, time to progression and response duration of RAD001C in patients with recurrent/metastatic breast cancer.

NCT Registration ID (from clinicaltrials.gov): NCT00255788
Participation: Participation in this study is restricted to invited centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 19, 2005 Closing Date: January 11, 2007

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032, (Canada) Dr. Susan Ellard, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 686657


Permanently Closed
I164A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer
A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer

Eligibility: Women with histologically documented breast cancer with metastatic or locally disease refractory to standard curative therapy. Prior adjuvant chemotherapy permissible; up to one prior chemotherapy regimen for metastatic disease and no prior taxane for metastatic disease. Prior hormonal therapy permitted, prior radiation therapy permitted if radiation involved <30% functioning bone marrow and >4 weeks. HER-2 positive patients may have had prior Herceptin treatment. ECOG 0,1,2. No brain metastases, no pre-existing neuropathy >= grade 2, no therapeutic anti-coagulation.

Objectives: To determine the efficacy, as measured by objective tumour response rate, of weekly OGX-011 and q 3 weekly docetaxel when given in combination to patients with advanced breast cancer. To assess the adverse events, tolerability, time to progression and overall survival in this population. To measure evidence of OGX-011 effect on serum clusterin levels.

NCT Registration ID (from clinicaltrials.gov): NCT00258375
Participation: CAKO, CALM, CAMN, CAMP, CANL, CAVA, CAVF, CAVK
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 27, 2005 Closing Date: September 29, 2006

Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752


Permanently Closed
I165A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer.
A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer.

Eligibility: Histologically or cytologically diagnosed prostate cancer with documented evidence of progression by rising PSA (>5 ng/mL at baseline). Patients must have metastatic or locally recurrent disease for which no curative therapy exists and for which systemic chemotherapy is indicated due to progression while receiving androgen ablative therapy. No prior chemotherapy except estramustine. Prior hormone therapy permitted but must be refractory and discontinued > 4 weeks (6 wks for bicalutamide). Prior radiation permitted if > 4 weeks. ECOG 0, 1, 2. Adequate organ function. No pre-existing neuropathy >= grade 2 or therapeutic anti-coagulation.

Objectives: To determine the efficacy, as measured by PSA response and duration of response, of weekly OGX-011 administered intravenously in combination with q 3 weekly docetaxel and prednisone, or docetaxel and prednisone in patients with HRPC. To determine objective response and duration in those with measurable disease at baseline. To determine tolerability and toxicity when given in this schedule. To measure evidence of OGX-011 and docetaxel or docetaxel effect on serum clusterin levels. To describe time to progression and overall patient survival for both cohorts.

NCT Registration ID (from clinicaltrials.gov): NCT00258388
Participation: Limited to selected centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 27, 2005 Closing Date: December 21, 2006

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I166This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours
This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours

Eligibility: Patients with histologically documented solid tumours, with locally advanced, metastatic or recurrent disease for which single agent docetaxel therapy is a reasonable therapeutic option. Presence of clinically and/or radiologically documented disease. ECOG performance status 0, 1 or 2. Prior chemotherapy (up to two prior regimens for metastatic/recurrent disease, and one regimen for adjuvant treatment, but no more than one taxane-containing regimen) is permitted. Prior surgery, hormone therapy, immunotherapy and radiation therapy are permitted.

Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AEG35156 administered intravenously in combination with docetaxel.

NCT Registration ID (from clinicaltrials.gov): NCT00357747
Participation: Participation in this phase I study is restricted to invited centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 2005 Closing Date: July 10, 2006

Permanently Closed
I166BThis is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours
This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours

Eligibility: Patients with histologically documented solid tumours, with locally advanced, metastatic or recurrent disease for which single agent docetaxel therapy is a reasonable therapeutic option. Presence of clinically and/or radiologically documented disease. ECOG performance status 0, 1 or 2. Prior chemotherapy (up to two prior regimens for metastatic/recurrent disease, and one regimen for adjuvant treatment, but no more than one taxane-containing regimen) is permitted. Prior surgery, hormone therapy, immunotherapy and radiation therapy are permitted.

Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AEG35156 administered intravenously in combination with docetaxel.

NCT Registration ID (from clinicaltrials.gov): NCT00372736
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 20, 2006 Closing Date: March 20, 2008

Permanently Closed
I167Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer
Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer

Eligibility: Patients with histologically or cytologically diagnosed prostate cancer that is advanced and non-curable with standard therapy. PSA progression with PSA>10 ng/mL at study entry. Primary tumour available for immunohistochemistry. No prior chemotherapy. Minimally symptomatic disease.

Objectives: To determine PSA response rate. To determine objective response rate and duration of response as measured by RECIST. To determine the tolerability and toxicity of BAY 43-9006 given to this patient population. To describe time to treatment failure and overall patient survival. To correlate the relationship between tumour markers and patients with response and with non-progression.

NCT Registration ID (from clinicaltrials.gov): NCT00093457
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 21, 2004 Closing Date: December 20, 2005

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I168A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma

Eligibility: Patients with histologically or cytologically documented hepatocellular carcinoma with locally advanced, recurrent or metastatic disease. Unidimensionally measurable disease by RECIST criteria. Prior intra-hepatic chemotherapy permitted; no prior systemic chemotherapy permitted. Patients must be > 4 weeks since major surgery, radiation therapy, local ablative therapy or intra-hepatic chemotherapy and must have hepatic reserve of Child-Turcotte-Pugh Class A or better. Patients with histological diagnosis must have archival tumour specimen available for correlative study.

Objectives: To assess the efficacy (response rate and stable disease rate) of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma. To assess the toxicity of SB-715992 in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma, as well as early progression rate, and, if responses are observed, response duration. To characterize the population pharmacokinetic (PK) parameters of SB-715992 including an assessment of significant covariates on SB-715992 PK and an assessment of the potential relationships between the pharmacokinetics of SB-715992 and relevant safety and efficacy endpoints. To describe the relationship between tumour expression of B-tubulin and KSP in archival paraffin fixed tumour tissue with clinical outcome of treatment with SB-715992. In a subset of separately consenting patients, to describe the changes in molecular markers of SB-715992 effect in PBMCs.

NCT Registration ID (from clinicaltrials.gov): NCT00095992
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 24, 2004 Closing Date: May 04, 2006

Chair: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2399, (Canada) Dr. Sharlene Gill, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2734


Permanently Closed
I169A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients with Metastatic or Recurrent Malignant Melanoma
A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients with Metastatic or Recurrent Malignant Melanoma

Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study

Objectives: To assess the efficacy and toxicity of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

NCT Registration ID (from clinicaltrials.gov): NCT00095953
Participation: Participation in this phase II study is restricted to invited centres.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 22, 2004 Closing Date: May 01, 2006

Chair: (Canada) Dr. Christopher Lee, BC Cancer Agency - Fraser Valley Centre, (604) 930-4017


Permanently Closed
I17NCIC CTG Phase I Study of Acivicin/Cisplatin in Non-Small Cell Lung Cancer
NCIC CTG Phase I Study of Acivicin/Cisplatin in Non-Small Cell Lung Cancer

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 01, 1985 Closing Date: April 25, 1988

Permanently Closed
I170A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma
A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma

Eligibility: Patients with recurrent glioblastoma multiforme (GBM) following primary surgery and radiation. No prior chemotherapy for recurrent disease permitted. Bidimensionally measureable disease. Stable dose of steriods. Paraffin embedded tumour sample available for study.

Objectives: To determine the toxicity, MAD, and RPII dose of GW572016 when given in patients with GBM taking CYP3A4 enzyme inducing anti-epileptic drugs. To assess the efficacy of GW572016 when administered daily in appropriate recommended doses to patients with recurrent GBM.

NCT Registration ID (from clinicaltrials.gov): NCT00099060
Participation: Participation in this study is restricted to invited centres.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 16, 2004 Closing Date: May 08, 2007

Chair: (Canada) Dr. Brian Thiessen, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2734


Permanently Closed
I171A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination with Standard Chemotherapy Regimens (CT) in Patients with Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumour Types Suitable for Treatment with Capecitabine
A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination with Standard Chemotherapy Regimens (CT) in Patients with Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumour Types Suitable for Treatment with Capecitabine

Eligibility: Histologically/cytologically documented advanced and/or metastatic NSCLC or colorectal cancer or other tumour types with clinically/radiologically documented disease. At least 6 months since prior adjuvant or neoadjuvant chemotherapy; prior adjuvant radiotherapy provided it was completed at least 6 months prior to registration; 14 days since major surgery; no prior therapy with angiogenesis inhibitor. For NSCLC: maximum of 1 prior single agent non-platinum chemotherapy for metastatic disease; no prior taxane therapy; no peripheral neuropathy > grade 1. For colorectal: suitable for first line therapy with capecitabine; not eligible with DPD deficiency or severe hand-foot syndrome from fluoropyrimidines. For other tumour types: suitable for treatment with capecitabine; patients with no more than 2 prior chemotherapy; LVEF >50% if prior anthracyclines/trastuzumab/cardiotoxic agents; not eligible with DPD deficiency or severe hand-foot syndrome from fluoropyrimidines.

Objectives: To determine the recommended phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colon cancer or other tumour types suitable for treatment with capecitabine and to determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of AZD2171 and standard chemotherapy given in these combinations. Also to assess the anti-tumour activity of AZD2171 in patients with measurable disease and to correlate patient outcomes (response) with baseline (tumour) and serial (urine and plasma) biomarkers.

NCT Registration ID (from clinicaltrials.gov): NCT00107250
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 13, 2005 Closing Date: February 17, 2009

Chair: (Canada) Dr. Derek Jonker, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70168, (Canada) Dr. Scott Laurie, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70173


Permanently Closed
I172Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma.
Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma.

Eligibility: Histologically documented mantle cell lymphoma non-refractory to prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. 1-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior PS-341/bortezomib or other investigational therapy (excluding flavopiridol). Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted. Adequate organ function; no pre-existing edema, neuropathy or dyspnea >= gr 2 or ascites or pleural effusions. No serious cardiovascular disease and adequate cardiac function - LVEF >= 45%.

Objectives: To determine the efficacy (response rate) of bortezomib given as a bolus intravenous injection twice weekly for 2 out of 3 weeks in combination with gemcitabine given as a 30 min. intravenous infusion once weekly for two consecutive weeks in patients with relapsed mantle cell lymphoma. To assess the toxicity of this combination as well as time to progression and response duration.

NCT Registration ID (from clinicaltrials.gov): NCT00377052
Participation: Limited to selected centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 14, 2006 Closing Date: September 19, 2008

Chair: (Canada) Dr. Tom Kouroukis, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 62487


Permanently Closed
I173A Phase I/II Study Of AZD0530 In Combination With Gemcitabine In Patients With Advanced Pancreatic Cancer
A Phase I/II Study Of AZD0530 In Combination With Gemcitabine In Patients With Advanced Pancreatic Cancer

Eligibility: Patients with unresectable, locally advanced or metastatic pancreatic cancer. No prior chemo therapy permitted except for 5FU(+/-folinic acid) or gemcitabine given concurrently with radiation.

Objectives: To determine the toxicity and RPII dose of AZD0530 when given in combination with Gemcitabine in patients with pancreatic cancer. To assess the efficacy of AZD0530 in combination with Gemcitabine in patients with pancreatic cancer.

NCT Registration ID (from clinicaltrials.gov): NCT00265876
Participation: Participation is limited to invited centres only.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 19, 2005 Closing Date: May 29, 2008

Chair: (Canada) Dr. Sharlene Gill, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2734


Permanently Closed
I175A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Selected Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer
A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Selected Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer

Eligibility: Histologically/cytologically documented advanced and/or metastatic NSCLC or colorectal cancer with clinically/radiologically documented disease. At least 6 months since prior adjuvant or neoadjuvant chemotherapy; prior adjuvant radiotherapy provided it was completed at least 6 months prior to registration; at least 14 days since major surgery; no prior therapy with angiogenesis inhibitor. ECOG PS of 0,1 OR 2. No uncontrolled hypertension or CVD. No peripheral neuropathy > grade 1. Adequate bone marrow reserve and renal and liver function. For NSCLC: maximum of one prior single agent non-platinum chemotherapy for metastatic disease; no prior gemcitabine therapy. For colorectal: suitable for first line therapy with FOLFOX-6; no prior oxaliplatin patients with DPD deficiency or history of severe hand- foot syndrome from fluoropyrimidines are not eligible.

Objectives: To determine the recommended phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colorectal cancer. To determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of AZD2171 and standard chemotherapy given in these combinations. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. To assess the anti-tumour activity of AZD2171 in combination with standard chemotherapy regimens in patients with measurable disease.

NCT Registration ID (from clinicaltrials.gov): NCT00343408
Participation: Limited to invited centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 08, 2005 Closing Date: March 30, 2007

Chair: (Canada) Dr. Eric (Xueyu) Chen, University Health Network, (416) 946-2263, (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955


Permanently Closed
I177A Phase I Study Of AT7519M Given Twice Weekly In Patients With Advanced Incurable Malignancy
A Phase I Study Of AT7519M Given Twice Weekly In Patients With Advanced Incurable Malignancy

Complexity Level: 1

Eligibility: Advanced/metastatic solid tumour or non-Hodgkins lymphoma. Patients with solid tumours may not have had more than 2 prior regimens for metastatic disease; patients with non-Hodgkins lymphoma must have, in the opinion of the investigator, failed all standard therapies.

Objectives: To determine the safety, tolerability, toxicity profile and define a recommended phase II dose of AT7519M given as a one hour infusion twice weekly for two weeks every 21 days in patients with advanced incurable malignancy.

NCT Registration ID (from clinicaltrials.gov): NCT00390117
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 22, 2006 Closing Date: April 04, 2011

Chair: (Canada) Dr. Eric (Xueyu) Chen, University Health Network, (416) 946-2263


Permanently Closed
I179Phase I Study Of CCI-779 In Combination With Carboplatin And Paclitaxel In Patients With Advanced Solid Tumours.
Phase I Study Of CCI-779 In Combination With Carboplatin And Paclitaxel In Patients With Advanced Solid Tumours.

Eligibility: Patients with histological confirmed advanced solid tumours for which therapy with carboplatin and paclitaxel is a reasonable therapeutic option (at expanded cohort at recommended dose: endometrial cancer or ovarian cancer patients only). Measurable or non-measurable disease (except in expanded cohort at recommended dose: all patients must have measurable disease).

Objectives: To establish the maximum tolerated dose (MTD) and recommended phase II dose (RPTD) of CCI 779 in combination with carboplatin and paclitaxel, administered intravenously on day 1 of a three week cycle, in patients with advanced solid cancers. To describe the frequency and severity of toxic effects of the combination of carboplatin, paclitaxel and CCI-779 given at the recommended dose and schedule. To document any evidence of objective antitumour activity of the combination of CCI-779 with carboplatin and paclitaxel, in those patients with measurable disease. To determine the pharmacokinetic profile of carboplatin, paclitaxel alone and with CCI-779 co-administration within patients, and to determine the pharamacokinetic profile of CCI-779 alone and with carboplatin and paclitaxel co-administration within the same patients.

NCT Registration ID (from clinicaltrials.gov): NCT00408655
Participation: Limited to invited centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 25, 2006 Closing Date: March 27, 2009

Chair: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2818


Permanently Closed
I18NCIC CTG Phase II Study of Flutamide in Breast
NCIC CTG Phase II Study of Flutamide in Breast

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 27, 1985 Closing Date: March 01, 1986

Permanently Closed
I181NCIC CTG Phase I Study Of AT9283 Given As A 24 Hour Infusion On Days 1 And 8 Every Three Weeks In Patients With Advanced Incurable Malignancy
NCIC CTG Phase I Study Of AT9283 Given As A 24 Hour Infusion On Days 1 And 8 Every Three Weeks In Patients With Advanced Incurable Malignancy

Eligibility: Advanced and/or metastatic solid tumours; non-Hodgkin's lymphoma judged to be refractory to standard therapies. Up to two prior chemotherapy regimens for metastatic disease permitted in patients with solid tumours; no chemotherapy limitations for non-Hodgkin's lymphoma patients.

Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks in patients with advanced incurable malignancy.

NCT Registration ID (from clinicaltrials.gov): NCT00443976
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 04, 2007 Closing Date: November 24, 2009

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032, (Canada) Dr. Susan Dent, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70167


Permanently Closed
I182A Phase II Study Of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, In Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma
A Phase II Study Of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, In Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

Eligibility: - Histologically documented diffuse large B-cell or mediastinal (thymic) large B-cell lymphoma, advanced or metastatic disease. - Patients must have received at least one, and up to two prior chemotherapy regimens, one of which must have been doxorubicin-based. - Patients may be relapsed post stem cell transplant as the preparative regimen and high dose chemotherapy will be considered as one regimen. Patients may have received one other non-chemotherapy regimen in the form of radiation. - No prior therapy with angiogenesis inhibitors or multi-targeted tyrosine kinase inhibitors - > 28 days since prior chemotherapy, hormonal therapy, radiation therapy or major surgery - Bidimensionally measurable disease; no known brain metastases - ECOG performance status: 0 or 1 - No serious medical conditions or cardiac disease (as specified in protocol); no uncontrolled hypertension

Objectives: 1. To assess the efficacy (response rate) of sunitinib given orally daily in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 2. To assess the toxicity of sunitinib in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 3. To assess the effects of sunitinib on the peripheral blood biomarkers circulating endothelial cells (CECs) and their precursors (CEPs) in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma.

NCT Registration ID (from clinicaltrials.gov): NCT00392496
Participation: Limited to invited centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 08, 2006 Closing Date: March 24, 2009

Chair: (Canada) Dr. Rena Buckstein, Odette Cancer Centre, (416) 480-5000 Ext. 5847


Permanently Closed
I183A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural Mesothelioma
A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural Mesothelioma

Eligibility: Patients with histological or cytological documented malignant pleural mesothelioma (advanced or metastatic disease). There will be two groups: Cohort 1 - previously treated patients: minimum of one prior platinum based chemotherapy, and Cohort 2 - previously untreated patients: No prior cytotoxic therapy permitted.

Objectives: To assess the efficacy (response rate, complete and partial) of sunitinib given orally daily for 4 out of every 6 weeks in patients with malignant pleural mesothelioma in two cohorts: in patients previously treated with cytotoxic therapy (cohort 1) and in patients who have not received previous cytotoxic therapy (cohort 2). To assess the toxicity safety and tolerability of sunitinib. To assess the duration of response or stable disease, stable disease rate, progression-free, median and overall survival rates

NCT Registration ID (from clinicaltrials.gov): NCT00392444
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 10, 2006 Closing Date: September 10, 2010

Chair: (Canada) Dr. Scott Laurie, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70173


Permanently Closed
I184A Phase II Study of Sunitinib, an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients with Unresectable, Locally Advanced or Metastatic Cervical Carcinoma
A Phase II Study of Sunitinib, an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients with Unresectable, Locally Advanced or Metastatic Cervical Carcinoma

Eligibility: Patients with histological/cytological documented squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix (advanced, recurrent or persistent disease). Maximum of 1 prior chemotherapy regimen for metastatic disease. Prior neoadjuvant, adjuvant or concurrent chemoradiartion is permitted.

Objectives: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. To assess the toxicity of sunitinib in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. To document time to progression, early objective progression rate, and, if objective responses are observed, response duration.

NCT Registration ID (from clinicaltrials.gov): NCT00389974
Participation: Limited to invited centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 09, 2006 Closing Date: May 12, 2008

Chair: (Canada) Dr. Helen J. MacKay, Odette Cancer Centre, (416) 480-5145


Permanently Closed
I185A Phase II Study Of Sunitinib (SU11248; NSC 736511) In Patients With Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma
A Phase II Study Of Sunitinib (SU11248; NSC 736511) In Patients With Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma

Eligibility: Patients with histological documented epithelial ovarian, fallopian tube carcinoma or primary peritoneal cancer (advanced or metastatic disease). Minimum of 1 and maximum of 2 prior chemotherapy regimens, one of which must be platinum containing.

Objectives: To assess the efficacy (response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. To assess the toxicity of sunitinib in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma. To document CA125 response rate, early objective progression rate, and, if objective responses are observed, response duration.

NCT Registration ID (from clinicaltrials.gov): NCT00388037
Participation: Limited to invited centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 10, 2006 Closing Date: April 17, 2008

Chair: (Canada) Dr. James Biagi, Cancer Centre of Southeastern Ontario at Kingston, (613) 549-6666 Ext. 4503


Permanently Closed
I186A Phase I/II Study of Sorafenib (BAY 43-9006) In Combination With Low Dose ARA-C (Cytarabine) In Elderly Patients With AML Or High-Risk MDS
A Phase I/II Study of Sorafenib (BAY 43-9006) In Combination With Low Dose ARA-C (Cytarabine) In Elderly Patients With AML Or High-Risk MDS

Complexity Level: 1

Eligibility: Patients age > 60 years and not suitable for intensive chemotherapy regimens with pathologically confirmed AML or high-risk MDS. o ECOG performance status 0, 1, or 2 o Prior Chemotherapy: None except hydroxyurea permitted provided discontinued > 48 hours prior to start of protocol therapy o Biochemistry: bilirubin and creatinine within normal limits, AST/ALT < 2 x UNL o No documented CNS involvement o No serious medical condition including: significant neurologic or psychiatric disorder, active uncontrolled infection

Objectives: Phase I Portion: To determine the recommended dose of sorafenib and Ara-C given in combination in elderly patients with AML or high-risk MDS who are not suitable for intensive chemotherapy. To determine the safety, tolerability, toxicity profile and dose limiting toxicities of the combination sorafenib and Ara-C in this patient population. Phase II Portion: To estimate the efficacy (as measured by complete response rate) of the recommended dose of sorafenib given orally in combination with Ara-C in elderly patients with AML or high-risk MDS. To describe the toxic effects and overall response rate (complete plus partial) in this population. To evaluate potential correlates of response in translational research studies including FLT-3 ITD's and point mutations in blasts.

NCT Registration ID (from clinicaltrials.gov): NCT00516828
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 24, 2007 Closing Date: December 10, 2009

Chair: (Canada) Dr. Brian Leber, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 575-7820, (Canada) Dr. David A. Macdonald, Ottawa Hospital Research Institute


Permanently Closed
I187A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer
A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer

Complexity Level: 1

Eligibility: Patients with histologically or cytologically documented colorectal cancer and must have locally advanced and/or metastatic colorectal cancer that is considered incurable and suitable for treatment with single agent irinotecan as a palliative intervention by the investigator. No anti-cancer treatment <= 21 days. ECOG 0, 1 or 2. Adequate cardiac function and acceptable end-organ function. No GI tract disease resulting in an iability to adsorb oral medication.

Objectives: 1.1 To determine the recommended phase II dose of irinotecan given on day 1 by 90 minute infusion every 21 days with a biologically active dose of AZD2281 given orally bid continuously, in patients with locally advanced or metastatic incurable colorectal cancer. 1.2 To determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of the combination of AZD2281 and irinotecan in this schedule. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. 1.3 To assess preliminary evidence of the anti-tumour activity of AZD2281 in combination with irinotecan in patients with colorectal cancer with measurable disease. 1.4 To demonstrate the pharmacodynamic activity of AZD2281 in combination with irinotecan by establishing its effects in tumour biopsies, cheek swabs and blood samples. 1.5 To assess the correlation, if any, between patients with tumours demonstrating microsatellite instability and anti-tu

NCT Registration ID (from clinicaltrials.gov): NCT00535353
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 13, 2007 Closing Date: March 08, 2012

Chair: (Canada) Dr. Eric (Xueyu) Chen, University Health Network, (416) 946-2263


Permanently Closed
I188A Phase I Clinical And Pharmacokinetic Study Of SB939 In Patients With Advanced Cancer
A Phase I Clinical And Pharmacokinetic Study Of SB939 In Patients With Advanced Cancer

Eligibility: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumours, refractory to standard therapy or for which conventional therapy is not effective. No anti-cancer treatment <= 28 days. ECOG 0, 1 or 2. Adequate cardiac function and acceptable end-organ function. No pre-exisitng peripheral neuropathy >= gr 2.

Objectives: 1.1 The primary objective of this study is to determine the recommended phase II dose of oral SB939 in patients with solid tumours. SB939 will be administered initially for 3 consecutive days every other week and then for 5 consecutive days every other week at escalating doses. 1.2 To determine the toxic effects of SB939 given in this schedule, their association with dose and pharmacokinetics 1.3 To assess the pharmacokinetic profile of SB939 given in this schedule 1.4 To assess preliminary evidence of anti-tumour effects in patients with measurable disease by documentation of objective response 1.5 To establish proof-of-principle for SB939 effects on histone acetylation by evaluation of histone acetylation and other biomarkers in peripheral blood mononuclear cells (PBMCs) at all dose levels and in tumour tissue at the recommended phase II dose level

NCT Registration ID (from clinicaltrials.gov): NCT00504296
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 21, 2007 Closing Date: March 16, 2010

Chair: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911


Permanently Closed
I189A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant Melanoma
A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant Melanoma

Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study.

Objectives: To assess the efficacy and toxicity of rIL-21 given by IV push for the first 5 days weeks 1, 3 and 5 at 50ug/kg/day in the first 6 previously untreated patients with metastatic or recurrent malignant melanoma. To characterize the pharmacokinetics of rIL-21 when dosed at 50 ?g/kg/day. To characterize the effects of rIL-21 on lymphocyte cell-count and soluble CD25 in serum as a potential biomarkers for drug activity. To evaluate the immunogenicity of rIL-21, specifically preexisting immunogenicity to the drug and antibody induction during treatment. To assess melanoma antigenic markers for response and non progression on archival tissue from patients enrolled on the study.

NCT Registration ID (from clinicaltrials.gov): NCT00514085
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 10, 2007 Closing Date: August 17, 2009

Chair: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Permanently Closed
I19NCIC CTG Phase II Study of Menogaril in Breast
NCIC CTG Phase II Study of Menogaril in Breast

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 30, 1985 Closing Date: March 15, 1986

Permanently Closed
I190A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination with Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer.
A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination with Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer.

Eligibility: Patients with histologically confirmed, extensive stage small cell lung cancer. No prior chemotherapy for SCLC. Prior radiation permitted to brain but not to lung. No uncontrolled diabetes or cardiac conditions and acceptable end-organ function. ECOG 0, 1 or 2. Unidimensionally measurable disease.

Objectives: 1.1 Phase I Objectives 1.1.1 To determine the recommended phase II dose of MK-0646 in combination with a standard etoposide and cisplatin (EP) chemotherapy regimen. 1.1.2 Evaluate the toxicity and preliminary efficacy of the combination. 1.2 Phase II Objectives 1.2.1 To assess the efficacy, as determined by objective response rate; including complete response rate, progression-free survival and overall survival. 1.2.2 To assess the toxicity and tolerability. 1.2.3 Explore the predictive and prognostic impact of biomarkers.

NCT Registration ID (from clinicaltrials.gov): NCT00869752
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 30, 2009 Closing Date: March 10, 2011

Chair: (Canada) Dr. Peter Ellis, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Permanently Closed
I191A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma
A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma

Complexity Level: 2

Eligibility: Patients must have a confirmed diagnosis of multiple myeloma and measurable disease, according to internationally accepted criteria for myeloma. Patients must have received prior treatment for multiple myeloma, and have relapsed or progressed on prior therapy. No more than three prior regimens; prior treatment must be completed at least 4 weeks prior to registration. ECOG performance status must be 0, 1 or 2; adequate hematologic and organ function.

Objectives: To assess the efficacy of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks to patients with relapsed or refractory multiple myeloma; to determine the adverse effects of AT9283; to evaluate potential predictive and prognostic biomarkers (marrow, blood); and to evaluate disease-related symptoms including pain, fatigue and mucositis.

NCT Registration ID (from clinicaltrials.gov): NCT01145989
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 15, 2010 Closing Date: July 26, 2012

Chair: (Canada) Dr. Anthony J. Reiman, Atlantic Health Sciences Corporation, (506) 648-6884


Permanently Closed
I192A Phase II Study of Ridaforolimus in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial Cancer
A Phase II Study of Ridaforolimus in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

Complexity Level: 2

Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of deforolimus activation. Prior hormonal treatment (adjuvant or metastatic), but no prior chemotherapy permitted.

Objectives: To assess the efficacy (response rate and duration of stable disease) of ridaforolimus given orally, once daily, 5 days/week continuously in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of ridaforolimus in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour).

NCT Registration ID (from clinicaltrials.gov): NCT00770185
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 26, 2008 Closing Date: August 11, 2010

Chair: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2818


Permanently Closed
I193A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.
A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.

Complexity Level: 2

Eligibility: Patients with documented chronic lymphocytic leukemia with at least one and up to 3 prior systemic treatment regimens. Patients must have either lymphocyte count >= 10 x 109/L or at least one measurable lymph node >= 2 cm x 2 cm to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.

Objectives: To assess the efficacy of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed and/or refractory chronic lymphocytic leukemia. To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed/refractory CLL. To demonstrate the pharmacodynamic activity of AT7519M in patients with relapsed and/or refractory CLL by establishing its effects on relevant biological endpoints (markers of CDK inhibition, apoptotic markers and cell cycle suppressors) in circulating lymphocytes. To investigate the relationship between baseline cytogenetics and other molecular markers in response to AT7519M.

NCT Registration ID (from clinicaltrials.gov): NCT01627054
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 21, 2012 Closing Date: November 22, 2013

Permanently Closed
I194A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma
A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma

Complexity Level: 2

Eligibility: Patients with documented mantle cell lymphoma non-refractory to prior therapy. Patients must have received at least one and up to 3 prior systemic treatment regimens. Patients must have at least one site of bidimensional disease to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.

Objectives: Primary: To assess the efficacy (as assessed by objective response rate) of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed mantle cell lymphoma (MCL). Secondary: - To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed mantle cell lymphoma. - To explore potential proteomic and metabolic serum markers of clinical response to AT7519M in MCL by assessment of peripheral blood collected at baseline and on study.

NCT Registration ID (from clinicaltrials.gov): NCT01652144
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 24, 2012 Closing Date: May 07, 2014

Chair: (Canada) Dr. John Kuruvilla, University Health Network, (416) 946-2827


Permanently Closed
I195A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer
A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer

Complexity Level: 2

Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. Up to 1 prior chemotherapy regimen is permitted. ECOG 0 or 1. Adequate cardiac function and acceptable end-organ function.

Objectives: 1.1 The primary objective of this study is to determine the efficacy (as measured by PSA response and progression free survival) of SB939 when given orally every other day 3 times a week, in patients with castration resistant prostate cancer, who have received 0-1 prior chemotherapy regimens. 1.2 To determine objective response and response duration in patients with measurable disease at baseline. 1.3 To determine the tolerability and toxicity of SB939 in this population. 1.4 Enumeration of Circulating Tumour Cells (CTC) at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment) using two methodologies. 1.5 To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue. 1.6 To explore the utility of ERG and PTEN expression on circulating tumour cells as a potential prognostic and predictive marker for response to SB939. 1.7 To describe time to PSA and time to objective progression in patients treated with SB939.

NCT Registration ID (from clinicaltrials.gov): NCT01075308
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 10, 2010 Closing Date: November 04, 2011

Chair: (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707, (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I196A Phase I/II Study of Foretinib in Patients with Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy (IND.196)
A Phase I/II Study of Foretinib in Patients with Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy (IND.196)

Complexity Level: 1

Eligibility: Patients with locally advanced or metastatic non-small cell lung cancer who have failed at least one prior chemotherapy regimen for advanced or metastatic disease. No more than 2 prior chemotherapy regimens for advanced or metastatic disease. EGFR status positive or unknown. Unidimensionally measurable disease. Archival tissue or fresh biopsy/FNA required at study entry.

Objectives: To determine the safety, tolerability, toxicity profile, dose limiting toxicities, pharmacokinetic profile and the recommended phase II dose of Foretinib in combination with standard erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown. To assess the anti-tumour activity of Foretinib in combination with erlotinib as evidenced by response rates, clinical benefit (complete or partial response or stable disease > 8 weeks duration), survival and an exploratory endpoint of early assessment of tumour size as a continuous variable, when compared to erlotinib alone. To correlate response with various biomarkers.

NCT Registration ID (from clinicaltrials.gov): NCT01068587
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 17, 2009 Closing Date: January 24, 2013

Chair: (Canada) Dr. Cheryl Ho, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2445, (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Permanently Closed
I197A Phase II Study of Foretinib in Patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer.
A Phase II Study of Foretinib in Patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer.

Complexity Level: 2

Eligibility: Advanced or recurrent/metastatic invasive breast cancer, that is ER, PR and HER2 negative.

Objectives: To determine the anti-tumour activity and toxicity of foretinib in this patient population.

NCT Registration ID (from clinicaltrials.gov): NCT01147484
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 25, 2010 Closing Date: August 02, 2013

Chair: (Canada) Dr. Daniel Rayson, QEII Health Sciences Centre, (902) 473-6106, (Canada) Dr. Sasha Lupichuk, Tom Baker Cancer Centre, (403) 521-3688


Permanently Closed
I198A Phase I/II Study of Foretinib in Combination with Lapatinib in Patients with Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer
A Phase I/II Study of Foretinib in Combination with Lapatinib in Patients with Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer

Complexity Level: 1

Eligibility: Histologically confirmed diagnosis of invasive breast cancer, that is HER2 positive as assessed by FISH or ICH 3+ staining (in accordance with ASCO guidelines) on the basis of local evaluation of HER2 status.

Objectives: To determine the recommended phase II dose (RP2D) of foretinib in combination with lapatinib, administered as a continuous daily oral dose, in patients with recurrent or metastatic HER2+ breast cancer. To evaluate the PK of lapatinib when given in combination with foretiib, preliminary evidence of anti-tumour activity, and to investigate the relationship between biomarkers and response.

NCT Registration ID (from clinicaltrials.gov): NCT01138384
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 03, 2010 Closing Date: March 05, 2013

Chair: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2752


Permanently Closed
I199A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix.
A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix.

Complexity Level: 2

Eligibility: Patients with histologically or cytologically confirmed squamous cell carcinoma or adenosquamous carcinoma of the cervix, or adenocarcinoma of the cervix. Clinically and/or radiologically documented disease. Only one prior chemotherapy regimen allowed. Patient must be > 4 weeks since chemotherapy, radiation therapy and surgery. No prior treatment with an mTOR inhibitor. Patient must have tumour tissue from their primary tumour available.

Objectives: 1.1 To assess the efficacy (objective response rate) of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.2 To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.3 To explore the relationship between expression of proteins in the mTOR pathway in archival tissue samples from patients on this trial and their objective response to therapy.

NCT Registration ID (from clinicaltrials.gov): NCT01026792
Participation: Limited to invited centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 17, 2009 Closing Date: October 27, 2011

Chair: (Canada) Dr. Anna Tinker, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707, (Canada) Dr. Helen J. MacKay, Odette Cancer Centre, (416) 480-5145


Permanently Closed
I1CNCIC CTG Phase II Study of Acivicin (AT125) in Colorectal Cancer
NCIC CTG Phase II Study of Acivicin (AT125) in Colorectal Cancer

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 03, 1981 Closing Date: May 31, 1982

Permanently Closed
I20NCIC CTG Phase II Study of Menogaril in Lymphoma
NCIC CTG Phase II Study of Menogaril in Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 30, 1985 Closing Date: November 14, 1988

Permanently Closed
I200A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.
A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.

Complexity Level: 2

Eligibility: Patients with histologically diagnosed translocation-associated sarcoma. Patients must have measurable disease. A tissue block from primary or metastatic tumour must be available for confirmation of diagnosis, translocation subtype and correlative studies. Up to 1 prior chemotherapy regimen in the metastatic setting is permitted. Prior radiation permitted. No pathologic cardiac arrhythmia within previous 12 months or myocardial infarction within 6 months. Acceptable end-organ function. ECOG 0, 1 or 2.

Objectives: To determine the efficacy (as measured by objective response) of SB939 when given orally every other day 3 times a week, in patients with translocation-associated sarcomas. To determine response duration, stable disease rate and progression free survival in these patients. To determine the tolerability and toxicity of SB939 in this population. To explore potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue.

NCT Registration ID (from clinicaltrials.gov): NCT01112384
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 18, 2010 Closing Date: January 25, 2012

Chair: (Canada) Dr. Quincy Chu, Cross Cancer Institute, (780) 432-8248


Permanently Closed
I202A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma
A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma

Complexity Level: 2

Eligibility: Patients with histologically documented malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means. Unidimensionally measurable disease. Prior adjuvant immunotherapy permitted; no other prior immunotherapy or chemotherapy permitted, except for RAF and MEK-Inhibitors. Patients must be >4 weeks since major surgery or radiation therapy, and >1 month since prior adjuvant immunotherapy. Patients must have archival tumour tissue from their primary and/or metastatic tumour available for correlative study.

Objectives: To compare efficacy of rIL-21 by IV bolus injection daily x 5 in weeks 1,3,and 5 every 8 weeka(Arm 1) & dacarbazine by IV injection Day 1 every 3 weeks(Arm 2)in previously untreated patients with metastatic or recurrent incurable malignant melanoma. The primary efficacy measure for this study is progression free survival. To compare the effect of rIL-21 and dacarbazine on response rate, duration of response, and overall survival. To determine the safety & toxicity profile of rIL-21 & dacarbazine. To characterize the effects of rIL-21 on lymphocyte sub-populations cell-count, dendritic cells sub-population cell counts, circulating miR-155 and soluble CD25 in blood before & after treatment as potential biomarkers for drug activity. To evaluate pre-existing & treatment induced immunogenicity of rIL-21 by measuring antibodies to rIL-21. To assess for pharmacogenomic markers of activity and toxicity. To assess pre-therapeutic markers for response & non-progression on archival specimens.

NCT Registration ID (from clinicaltrials.gov): NCT01152788
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 28, 2010 Closing Date: February 29, 2012

Chair: (Canada) Dr. Kerry J. Savage, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2641, (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, (416) 480-4662


Permanently Closed
I203A Phase I Study of SB939 in Pediatric Patients with Refractory Solid Tumours and Leukemia.
A Phase I Study of SB939 in Pediatric Patients with Refractory Solid Tumours and Leukemia.

Complexity Level: 1

Eligibility: Part A. Patients must have recurrent or refractory solid tumours, lymphoma or CNS tumours (excluding diffuse intrinsic pontine gliomas). Part B. Patients must have recurrent or refractory leukemia. Part C. Patients must have neuroblastoma, or medulloblastoma/CNS primitive neuroectodermal tumour (PNET). All patients must have histologic verification of malignancy, adequate bone marrow, renal, cardiac and liver function, and must meet all other eligibility criteria as defined in Protocol Section 5.

Objectives: Part A. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of oral SB939 in pediatric patients with solid tumours, with SB939 administered orally every other day three times/week for three consecutive weeks, followed by one week off-dosing. Part B. To assess the tolerability of the solid tumour RP2D in patients with recurrent or refractory leukemia once the RP2D has been established in solid tumours. Part C. To determine the RP2D of oral SB939 in combination with a fixed dose of 13-cis-retinoic acid in children with refractory or recurrent neuroblastoma, medulloblastoma/CNS neuroectodermal tumour (PNET), using the recommended dose determined in Part A of this study. To characterize the pharmacokinetics of SB939 in a pediatric population. To describe any antitumour activity of SB939 in pediatric tumours when given as a single agent, and when given in combination with 13-cis-retinoic acid.

NCT Registration ID (from clinicaltrials.gov): NCT01184274
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 21, 2010 Closing Date: January 25, 2012

Permanently Closed
I204A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression.
A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression.

Complexity Level: 2

Eligibility: Patients must have histologically confirmed diagnosis of glioblastoma multiforme (GBM), with recurrent or progressive disease following or during primary treatment not curable with standard therapies. Must have formalin fixed paraffin embedded tissue available for translational studies. Presence of bidimensionally measurable enhancing lesions on CT or MRI, with at least one lesion with a minimum dimension of 1 cm x 1 cm (i.e. both dimensions must be > 1.0 cm). ECOG performance of 0, 1 or 2.Age > 18 years of age. Patients may have received prior adjuvant chemotherapy and/or concurrent chemoradiation as part of primary therapy, but must have received no therapy for recurrent/ progressive GBM

Objectives: To determine the efficacy of PX-866 given orally daily in patients with glioblastoma at the time of first relapse or progression as assessed by objective response and early progression rates. To determine the safety and tolerability of PX-866 in patients with glioblastoma at first relapse/progression given in a daily oral schedule. To explore the relationship between objective response and molecular markers in archival tissue from glioblastoma patients treated with PX-866 orally daily.

NCT Registration ID (from clinicaltrials.gov): NCT01259869
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 09, 2010 Closing Date: September 24, 2012

Chair: (Canada) Dr. Marshall W. Pitz, CancerCare Manitoba, (204) 787-8642


Permanently Closed
I205A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).

Complexity Level: 2

Eligibility: Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present. Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration. Either:PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of >= 5 ng/ml and must be performed no longer than 7 days prior to trial registration.OR Radiological Progression. The PSA must be >=5 ng/ml at the time of study entry. ECOG performance of 0, 1 or 2; Age > 18 years of age. All patients must have formalin fixed paraffin embedded tissue. Presence of clinically and/or radiologically documented disease.

Objectives: To determine the efficacy of PX-866 when given orally daily in patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease.To determine the tolerability and toxicity. of PX-866 in this population. To investigate additional potential measures of efficacy including: PSA response rate, Objective response rate, Change in circulating tumour cell number during treatment. To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue and baseline circulating tumour cells. In selected participating centres, to determine evidence of effect on PI3K activation pre- and post administration of PX-866 in platelets

NCT Registration ID (from clinicaltrials.gov): NCT01331083
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 2011 Closing Date: January 10, 2014

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746, (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


Permanently Closed
I207A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma
A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma

Complexity Level: 2

Eligibility: histologically or cytologically confirmed malignant pleural mesothelioma; advanced and/or metastatic disease; at least one site of disease must be unidimensionally measurable; patients are eligible after first line cytotoxic chemotherapy has failed; patients must have received one, but no more than one, combination chemotherapy regimen for advanced disease, which must have contained platinum based chemotherapy

Objectives: To assess the efficacy of PF-03446962 given by IV day 1 of a 2 week cycle in patients with advanced malignant pleural mesothelioma; to assess the toxicity, safety and tolerability of PF-03446962; to assess the duration of response or stable disease, stable disease rate, progression free, median and overall survival rates; to collect tissue and blood for banking and correlative science evaluation.

NCT Registration ID (from clinicaltrials.gov): NCT01486368
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Permanently Closed
Activation Date: November 30, 2011 Closing Date: January 09, 2014

Chair: (Canada) Dr. Paul Wheatley-Price, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 79859, (Canada) Dr. Quincy Chu, Cross Cancer Institute, (780) 432-8248


Permanently Closed
I209A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer
A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer

Complexity Level: 2

Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Tumour block available. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. No prior chemotherapy for recurrent/metastatic disease. No prior docetaxel unless given adjuvantly and >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function.

Objectives: 1. To evaluate efficacy which will be based on the lack of disease progression measured at 12 weeks. 2a. To determine the tolerability and toxicity of Reolysin and docetaxel when given in combination. 2b. To investigate additional potential measures of efficacy including CTC status, CTC conversion rate, change in PSA levels, Objective response rate and effect of both treatments on overall survival. 2c. Explore potential molecular factors predictive of response in archival tumour and baseline CTCs.

NCT Registration ID (from clinicaltrials.gov): NCT01619813
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 11, 2012 Closing Date: September 25, 2015

Chair: (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707


Permanently Closed
I21NCIC CTG Phase II Study of Menogaril in Melanoma
NCIC CTG Phase II Study of Menogaril in Melanoma

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 30, 1985 Closing Date: March 15, 1986

Permanently Closed
I212A Pilot Study of Imetelstat given Intravenously on Day 1 and 8 of a 21 Day Schedule Alone and With Standard 13-Cis-Retinoic Acid in Children with Recurrent and/or Refractory Neuroblastoma.
A Pilot Study of Imetelstat given Intravenously on Day 1 and 8 of a 21 Day Schedule Alone and With Standard 13-Cis-Retinoic Acid in Children with Recurrent and/or Refractory Neuroblastoma.

Complexity Level: 1

Eligibility: Patients must have recurrent or refractory neuroblastoma which is histologically verified at either original diagnosis or relapse.

Objectives: 1.1 In patients with relapsed and/or refractory neuroblastoma, to confirm the feasibility of administering imetelstat given at the recommended pediatric dose as determined in the Children's Oncology Group Study ADVL1112 (a phase I study of imetelstat, a telomerase inhibitor, in children with recurrent or refractory solid tumours and lymphoma), alone and in combination with 13-cis-retinoic acid. 1.2 In patients with relapsed and/or refractory neuroblastoma to assess the impact of imetelstat on hematopoietic stem cells and neuroblastoma tumour initiating cells. 1.3 In patients with relapsed and/or refractory neuroblastoma to evaluate: - The correlation of tumour and plasma C-circles. - The role of plasma C-circles as a tumour biomarker for alternative lengthening of telomeres (ALT). - Changes in plasma C-circles induced by treatment with imetelstat.

NCT Registration ID (from clinicaltrials.gov): NCT01916187
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 30, 2013 Closing Date: November 22, 2013

Chair: (Canada) Dr. Victor Lewis, Alberta Children's Hospital, (403) 955-7211


Permanently Closed
I22NCIC CTG Phase II Study of Deoxycoformycin in Hairy Cell
NCIC CTG Phase II Study of Deoxycoformycin in Hairy Cell

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 26, 1985 Closing Date: July 15, 1986

Permanently Closed
I23NCIC CTG Phase II Study of Acivicin in Colon
NCIC CTG Phase II Study of Acivicin in Colon

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 17, 1985 Closing Date: April 28, 1986

Permanently Closed
I24NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell
NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 06, 1985 Closing Date: November 26, 1986

Permanently Closed
I25NCIC CTG Phase II Study of Trimetrexate in Ovary
NCIC CTG Phase II Study of Trimetrexate in Ovary

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 28, 1986 Closing Date: May 02, 1988

Permanently Closed
I26NCIC CTG Phase II Study of Trimetrexate in Melanoma
NCIC CTG Phase II Study of Trimetrexate in Melanoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 28, 1986 Closing Date: November 06, 1987

Permanently Closed
I27NCIC CTG Phase II Study of Trimetrexate in Glioma
NCIC CTG Phase II Study of Trimetrexate in Glioma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 28, 1986 Closing Date: March 14, 1988

Permanently Closed
I28NCIC CTG Phase II Study of Trimetrexate in Sarcoma
NCIC CTG Phase II Study of Trimetrexate in Sarcoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 28, 1986 Closing Date: December 31, 1987

Permanently Closed
I28ANCIC CTG Phase II Study of Trimetrexate (q 2wks) in Sarcoma
NCIC CTG Phase II Study of Trimetrexate (q 2wks) in Sarcoma

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 25, 1988 Closing Date: January 09, 1989

Permanently Closed
I29NCIC CTG Phase II Study of Adriamycin/DTIC/Ifosfamide in Soft Tissue Sarcoma
NCIC CTG Phase II Study of Adriamycin/DTIC/Ifosfamide in Soft Tissue Sarcoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 21, 1986 Closing Date: November 03, 1987

Permanently Closed
I2LNCIC CTG Phase II Study of Acivicin (AT125) in Patients With Metastatic Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of Acivicin (AT125) in Patients With Metastatic Non-Small Cell Lung Cancer

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 03, 1981 Closing Date: March 09, 1984

Permanently Closed
I3NCIC CTG Phase II Study of Spirogermanium in Poor Prognosis Non-Hodgkin's Lymphoma
NCIC CTG Phase II Study of Spirogermanium in Poor Prognosis Non-Hodgkin's Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 09, 1983 Closing Date: May 14, 1984

Permanently Closed
I30NCIC CTG Phase II Study of VP-16/Cisplatin in Mesothelioma
NCIC CTG Phase II Study of VP-16/Cisplatin in Mesothelioma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 09, 1986 Closing Date: April 01, 1987

Permanently Closed
I31NCIC CTG Phase II Study of VP-16/Carboplatin in Extensive Small Cell Lung Cancer
NCIC CTG Phase II Study of VP-16/Carboplatin in Extensive Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 18, 1985 Closing Date: October 09, 1986

Permanently Closed
I32NCIC CTG Phase I Study of Trimetrexate Glucuronate Daily x 9 Bolus
NCIC CTG Phase I Study of Trimetrexate Glucuronate Daily x 9 Bolus

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 01, 1985 Closing Date: December 01, 1985

Permanently Closed
I33NCIC CTG Phase II Study of Epirubicin in Small Cell Lung Cancer
NCIC CTG Phase II Study of Epirubicin in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 29, 1986 Closing Date: July 31, 1987

Permanently Closed
I34NCIC CTG Phase I Study of Levamisole/Interferon in Melanoma
NCIC CTG Phase I Study of Levamisole/Interferon in Melanoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 13, 1986 Closing Date: May 07, 1987

Permanently Closed
I35NCIC CTG Phase II Study of CMF/Lonidamine in Breast
NCIC CTG Phase II Study of CMF/Lonidamine in Breast

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 08, 1986 Closing Date: January 08, 1988

Permanently Closed
I36NCIC CTG Phase I Study of Didemnin-B Weekly x 4 q 6 wks
NCIC CTG Phase I Study of Didemnin-B Weekly x 4 q 6 wks

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 01, 1986 Closing Date: November 29, 1991

Permanently Closed
I38NCIC CTG Phase II Study of TNF in Renal Cell
NCIC CTG Phase II Study of TNF in Renal Cell

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 01, 1988 Closing Date: September 01, 1989

Permanently Closed
I4NCIC CTG Phase II Study of Lonidamine in Hypernephroma
NCIC CTG Phase II Study of Lonidamine in Hypernephroma

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 01, 1982 Closing Date: May 05, 1984

Permanently Closed
I42NCIC CTG Phase II Study of Amonafide in Small Cell Lung Cancer
NCIC CTG Phase II Study of Amonafide in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 23, 1987 Closing Date: April 25, 1988

Permanently Closed
I43NCIC CTG Phase I Study of CI-937 Bolus q 3 to 4 wks
NCIC CTG Phase I Study of CI-937 Bolus q 3 to 4 wks

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 19, 1988 Closing Date: August 10, 1990

Permanently Closed
I44NCIC CTG Phase I Study of CI-937 Given Weekly x 3 Every 5 Weeks
NCIC CTG Phase I Study of CI-937 Given Weekly x 3 Every 5 Weeks

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 18, 1988 Closing Date: March 11, 1991

Permanently Closed
I45NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer
NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 27, 1989 Closing Date: April 15, 1990

Permanently Closed
I46NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma
NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 25, 1989 Closing Date: May 11, 1990

Permanently Closed
I47NCIC CTG Phase II Study of LY186641 in Small Cell Lung Cancer
NCIC CTG Phase II Study of LY186641 in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 25, 1989 Closing Date: November 30, 1990

Permanently Closed
I48NCIC CTG Phase II Study of "Intensive PCV-3" Chemotherapy For Anaplastic Oligodendroglioma
NCIC CTG Phase II Study of "Intensive PCV-3" Chemotherapy For Anaplastic Oligodendroglioma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 06, 1989 Closing Date: September 02, 1992

Chair: (Canada) Dr. David R. MacDonald, London Regional Cancer Program, (519) 685-8640, (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, (403) 944-1260


Permanently Closed
I49NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma
NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 19, 1990 Closing Date: November 30, 1990

Permanently Closed
I4BNCIC CTG Phase II Study of Lonidamine in Breast Cancer
NCIC CTG Phase II Study of Lonidamine in Breast Cancer

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 01, 1983 Closing Date: May 13, 1985

Permanently Closed
I5NCIC CTG Phase II Study of Spirogermanium in Melanoma
NCIC CTG Phase II Study of Spirogermanium in Melanoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 01, 1983 Closing Date: May 14, 1984

Permanently Closed
I50NCIC CTG Phase II Study of Gemcitabine in Small Cell Lung Cancer
NCIC CTG Phase II Study of Gemcitabine in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 04, 1991 Closing Date: September 29, 1992

Permanently Closed
I51NCIC CTG Phase I Study of GM-CSF + Carboplatin/Cyclophosphamide in Ovary
NCIC CTG Phase I Study of GM-CSF + Carboplatin/Cyclophosphamide in Ovary

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 29, 1989 Closing Date: February 10, 1990

Permanently Closed
I51ANCIC CTG Phase I Study of GM-CSF Plus Carboplatin in Ovary
NCIC CTG Phase I Study of GM-CSF Plus Carboplatin in Ovary

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 10, 1990 Closing Date: September 28, 1990

Permanently Closed
I52NCIC CTG Phase I Study of GMCSF in Small Cell Lung Cancer
NCIC CTG Phase I Study of GMCSF in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 06, 1989 Closing Date: September 19, 1990

Permanently Closed
I54NCIC CTG Phase II Study of TCAR in Malignant Glioma
NCIC CTG Phase II Study of TCAR in Malignant Glioma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 18, 1990 Closing Date: May 28, 1991

Permanently Closed
I55NCIC CTG Phase II Study of 10-edam in Soft Tissue Sarcoma
NCIC CTG Phase II Study of 10-edam in Soft Tissue Sarcoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 04, 1990 Closing Date: March 06, 1992

Permanently Closed
I56NCIC CTG Phase II Study of DuP937 in Patients With Melanoma
NCIC CTG Phase II Study of DuP937 in Patients With Melanoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 07, 1991 Closing Date: April 23, 1992

Permanently Closed
I57NCIC CTG Phase II Study of DUP937 in Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of DUP937 in Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 1991 Closing Date: April 02, 1992

Permanently Closed
I58NCIC CTG Phase II Study of DuP 937 in Patients With Colorectal Cancer
NCIC CTG Phase II Study of DuP 937 in Patients With Colorectal Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 1991 Closing Date: November 10, 1991

Permanently Closed
I59NCIC CTG Phase I Study of IL-3 in Patients With Relapsed Ovarian Cancer Receiving Carboplatin
NCIC CTG Phase I Study of IL-3 in Patients With Relapsed Ovarian Cancer Receiving Carboplatin

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 10, 1990 Closing Date: March 27, 1992

Permanently Closed
I6NCIC CTG Phase II Study of Interferon in Renal Cell Cancer
NCIC CTG Phase II Study of Interferon in Renal Cell Cancer

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 01, 1983 Closing Date: September 20, 1984

Permanently Closed
I60NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer
NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 29, 1990 Closing Date: September 17, 1991

Permanently Closed
I61NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Malignant Melanoma
NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Malignant Melanoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 08, 1991 Closing Date: January 21, 1992

Permanently Closed
I62NCIC CTG Phase II Study of Subcutaneous R-Interleukin-2 Plus Interferon Alfa-2a in Previously Treated Patients With Multiple Myeloma
NCIC CTG Phase II Study of Subcutaneous R-Interleukin-2 Plus Interferon Alfa-2a in Previously Treated Patients With Multiple Myeloma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 07, 1991 Closing Date: February 17, 1993

Permanently Closed
I65NCIC CTG Phase II Study of Elsamitrucin in Patients With Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of Elsamitrucin in Patients With Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 01, 1992 Closing Date: December 04, 1992

Permanently Closed
I66Phase II Study of Interferon Alfa-2a and 13-cis-retinoic Acid in Patients With Non-Small Cell Lung Cancer
Phase II Study of Interferon Alfa-2a and 13-cis-retinoic Acid in Patients With Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 15, 1992 Closing Date: May 28, 1993

Permanently Closed
I67NCIC CTG Phase I Study Of Fostriecin Given as an Intravenous Bolus Daily for 5 Consecutive Days
NCIC CTG Phase I Study Of Fostriecin Given as an Intravenous Bolus Daily for 5 Consecutive Days

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 10, 1992 Closing Date: May 21, 1996

Permanently Closed
I68NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer
NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 01, 1992 Closing Date: June 30, 1993

Chair: (Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, (416) 480-5145


Permanently Closed
I69NCIC CTG Phase II Study of Taxotere in Patients With Extensive Small Cell Lung Cancer
NCIC CTG Phase II Study of Taxotere in Patients With Extensive Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 08, 1993 Closing Date: October 18, 1993

Permanently Closed
I7NCIC CTG Phase II Study of Mitoxantrone in Mesothelioma
NCIC CTG Phase II Study of Mitoxantrone in Mesothelioma

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 12, 1983 Closing Date: February 15, 1985

Permanently Closed
I70NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma
NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 24, 1992 Closing Date: February 03, 1993

Permanently Closed
I71NCIC CTG Phase II Study of Topotecan in Recurrent or Metastatic Soft Tissue Sarcoma
NCIC CTG Phase II Study of Topotecan in Recurrent or Metastatic Soft Tissue Sarcoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 08, 1992 Closing Date: February 04, 1994

Permanently Closed
I73NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer
NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 27, 1992 Closing Date: February 28, 1995

Permanently Closed
I74NCIC CTG Phase I Study of Biweekly Taxol/Cisplatin as Initial Chemotherapy for Ovarian Cancer
NCIC CTG Phase I Study of Biweekly Taxol/Cisplatin as Initial Chemotherapy for Ovarian Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 02, 1992 Closing Date: October 07, 1994

Chair: (Canada) Dr. Paul J. Hoskins, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2365


Permanently Closed
I75NCIC CTG Phase II Study of Topotecan in Patients With Malignant Glioma
NCIC CTG Phase II Study of Topotecan in Patients With Malignant Glioma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 08, 1992 Closing Date: January 25, 1994

Permanently Closed
I76NCIC CTG Phase II Study of Taxotere in Malignant Glioma
NCIC CTG Phase II Study of Taxotere in Malignant Glioma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 1994 Closing Date: April 28, 1995

Permanently Closed
I77NCIC CTG Phase II Study of Docetaxel in Recurrent or Metastatic Soft Tissue Sarcoma
NCIC CTG Phase II Study of Docetaxel in Recurrent or Metastatic Soft Tissue Sarcoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 28, 1994 Closing Date: June 30, 1995

Permanently Closed
I78NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma
NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 01, 1993 Closing Date: October 25, 1994

Chair: (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955


Permanently Closed
I79NCIC CTG Phase I/II Study of Taxol and Ifosfamide in Advanced Non-Small Cell Lung Cancer
NCIC CTG Phase I/II Study of Taxol and Ifosfamide in Advanced Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 13, 1993 Closing Date: February 08, 1996

Chair: (Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4522


Permanently Closed
I8NCIC CTG Phase II Study of N-methylformamide in Colon
NCIC CTG Phase II Study of N-methylformamide in Colon

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 14, 1984 Closing Date: April 29, 1985

Permanently Closed
I80NCIC CTG Phase I Study of Taxol and Concurrent Radiotherapy in Non-Small Cell Lung Cancer
NCIC CTG Phase I Study of Taxol and Concurrent Radiotherapy in Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 14, 1994 Closing Date: June 14, 1996

Permanently Closed
I81NCIC CTG Phase II Study of Tallimustine in Patients With Previously Treated Small Cell Lung Cancer
NCIC CTG Phase II Study of Tallimustine in Patients With Previously Treated Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 16, 1994 Closing Date: June 14, 1995

Permanently Closed
I82NCIC CTG Randomized Phase II Study of Topotecan in Previously Treated Patients With Ovarian Cancer
NCIC CTG Randomized Phase II Study of Topotecan in Previously Treated Patients With Ovarian Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 08, 1994 Closing Date: April 22, 1997

Chair: (Canada) Dr. Paul J. Hoskins, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2365


Permanently Closed
I84NCIC CTG Phase I Study of Topotecan and Etoposide in Patients With Refractory or Relapsed Acute Leukemia
NCIC CTG Phase I Study of Topotecan and Etoposide in Patients With Refractory or Relapsed Acute Leukemia

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 07, 1994 Closing Date: November 23, 1995

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
I85A Phase I Study of BMS-182751 (JM-216) and Etoposide in Patients With Previously Untreated Cancer
A Phase I Study of BMS-182751 (JM-216) and Etoposide in Patients With Previously Untreated Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 22, 1994 Closing Date: November 08, 1994

Chair: (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955


Permanently Closed
I86NCIC CTG Phase I Study of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) Formulation Given as a 24 Hour Continuous Infusion Weekly x 4 Every 5 Weeks
NCIC CTG Phase I Study of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) Formulation Given as a 24 Hour Continuous Infusion Weekly x 4 Every 5 Weeks

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 13, 1995 Closing Date: October 28, 1996

Permanently Closed
I87A Phase IB Biomodulation Study of Increasing Doses of Weekly Levamisole in the Adjuvant Treatment of Patients With Moderate/High Risk, Localized, Resected Cutaneous Malignant Melanoma
A Phase IB Biomodulation Study of Increasing Doses of Weekly Levamisole in the Adjuvant Treatment of Patients With Moderate/High Risk, Localized, Resected Cutaneous Malignant Melanoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 26, 1995 Closing Date: May 01, 1997

Chair: (Canada) Dr. Ian Quirt, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2249


Permanently Closed
I88A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma
A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 03, 1995 Closing Date: April 29, 1997

Permanently Closed
I89NCIC CTG Phase II Study of LY231514 in Patients With Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of LY231514 in Patients With Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 12, 1995 Closing Date: February 04, 1997

Chair: (Canada) Dr. James Rusthoven, (905) 648-7936


Permanently Closed
I9NCIC CTG Phase II Study of TCAR in Colon
NCIC CTG Phase II Study of TCAR in Colon

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 1985 Closing Date: March 05, 1986

Permanently Closed
I90NCIC CTG Phase II Study of LY231514 in Patients With Locally Advanced/Metastatic Colorectal Cancer
NCIC CTG Phase II Study of LY231514 in Patients With Locally Advanced/Metastatic Colorectal Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 12, 1995 Closing Date: June 21, 1996

Chair: (Canada) Dr. Christine Cripps, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70176


Permanently Closed
I91NCIC CTG Phase I/II Study of BB2516 in Patients with Malignant Melanoma and Cutaneous Metastases
NCIC CTG Phase I/II Study of BB2516 in Patients with Malignant Melanoma and Cutaneous Metastases

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 01, 1995 Closing Date: March 31, 1997

Permanently Closed
I93NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer
NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 24, 1996 Closing Date: September 24, 1998

Chair: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2032


Permanently Closed
I94NCIC CTG Phase II Study of Gemcitabine in Patients With Malignant Glioma
NCIC CTG Phase II Study of Gemcitabine in Patients With Malignant Glioma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 06, 1996 Closing Date: April 28, 1997

Permanently Closed
I95NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract
NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 06, 1996 Closing Date: October 03, 1997

Permanently Closed
I96NCIC CTG Phase I Study of JM216 Plus VP16(Etoposide)
NCIC CTG Phase I Study of JM216 Plus VP16(Etoposide)

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 15, 1996 Closing Date: June 03, 1999

Chair: (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955


Permanently Closed
I97NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer
NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 10, 1996 Closing Date: January 06, 1998

Chair: (Canada) Dr. Kong Eng Khoo, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 683930


Permanently Closed
I98NCIC CTG Phase I/II Study of Tomudex and Doxorubicin in Patients With Locally Advanced, Inoperable or Metastatic Gastric Cancer
NCIC CTG Phase I/II Study of Tomudex and Doxorubicin in Patients With Locally Advanced, Inoperable or Metastatic Gastric Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 24, 1996 Closing Date: April 07, 1999

Chair: (Canada) Dr. Georg A. Bjarnason, Odette Cancer Centre, (416) 480-6100 Ext. 5847


Permanently Closed