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Current Investigational New Drug Program TrialsCurrent = Active, Planned, Closed after July 01, 2002This information is intended for use by doctors and other health care professionals. If you are a cancer patient, we recommend that you discuss this information with your doctor, who knows you, and who has the facts about your disease. If you are interested in taking part in a clinical trial, your doctor can help explain how this information may apply to you, and if this is the best treatment option in your particular case. Last Updated: May 22, 2013 PHASE I STUDIESAcute Myeloid Leukemia - I141 Brain - I162 Colon - I171 I175 I187 Lung Cancer - Non-Small Cell - I171 I175 I215 Multiple Sites - I130 I134 I144 I147 I154 I178 I188 I203 Myelodysplastic Syndrome - I141 Neuroblastoma - I212 Prostate - I153 Rectal - I187 Unknown or unspecified malignancy - I166 I166B I177 I179 I181 PHASE I-II STUDIESAcute Myeloid Leukemia - I186 Brain - I170 Breast - I198 Colon - I208 I214 Lung Cancer - Non-Small Cell - I196 I214 Lung Cancer - Small Cell (= oat cell) - I190 Myelodysplastic Syndrome - I186 Pancreas - I173 PHASE II STUDIESBrain - I142 I204 Breast - I163 I164 I197 I213 Cervix - I184 I199 Chronic Lymphocytic Leukemia - I193 Colon - I146 I210 Endometrial (non-sarcomatous uterine c.) - I148 I160 I192 Fallopian Tube - I185 Head and Neck - I157 Liver (hepato-cellular) - I168 Lung Cancer - Non-Small Cell - I211 Melanoma - I156 I169 I189 I202 Mesothelioma - I183 I207 Multiple Myeloma - I145 I191 Multiple Sites - I206 Non-Hodgkins Lymphoma - I150 I152 I172 I182 I194 Ovary - I149 I185 Prostate - I165 I167 I195 I205 I209 Renal (kidney) - I161 Sarcoma - soft tissue - I155 I200 PHASE I STUDIESAcute Myeloid Leukemia I141A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic SyndromeEligibility: 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. Participant: Limited to invited cancer centres only. Status: Closed Activation Date: October 01, 2001 , Closing Date: April 01, 2004 Chairs: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567 (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567 Brain I162A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant GliomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: July 25, 2006 , Closing Date: June 01, 2009 Chairs: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2277 Colon 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 CapecitabineEligibility: 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.< BR> 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: January 13, 2005 , Closing Date: February 17, 2009 Chairs: (Canada) Dr. Derek Jonker, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70168 (Canada) Dr. Scott Laurie, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70173 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 CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: August 08, 2005 , Closing Date: March 30, 2007 Chairs: (Canada) Dr. Eric (Xueyu) Chen, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2263 (Canada) Dr. Glenwood Goss, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 73132 I187A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: August 13, 2007 , Closing Date: March 08, 2012 Chairs: (Canada) Dr. Eric (Xueyu) Chen, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2263 Lung Cancer - Non-Small Cell I215A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: January 30, 2013 Chairs: (Canada) Dr. Garth Nicholas, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70178 (Canada) Dr. John Goffin, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 Multiple Sites I130A Phase I Study of T900607 Given Once Every Three Weeks in Patients With Advanced Refractory CancerEligibility: 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. Participant: Limited to invited cancer centres only. Status: Closed Activation Date: April 07, 2000 , Closing Date: December 19, 2002 Chairs: (Canada) Dr. Karl Belanger, CHUM - Hopital Notre-Dame, 1(514) 890-8444 (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2032 I134A Phase I Study of BAY 38-3441 Given as a Short Infusion Daily For Five Days Every Three WeeksEligibility: 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. Participant: Limited to invited cancer centres only. Status: Closed Activation Date: May 12, 2000 , Closing Date: January 16, 2003 Chairs: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911 (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911 (Canada) Dr. Gerald Batist, Jewish General Hospital, 1(514) 340-8222 Ext. 5418 I144A Phase I Study of Oral LY293111 Given Daily in Combination With Irinotecan in Patients With Solid TumoursEligibility: 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. Participant: Limited to invited cancer centres only. Status: Closed Activation Date: March 23, 2001 , Closing Date: June 29, 2004 Chairs: (Canada) Dr. Malcolm Moore, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2263 (Canada) Dr. Malcolm Moore, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2263 I147Phase I Study of GS7836 in Patients With Advanced Incurable Solid TumoursEligibility: 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. Participant: Limited to invited cancer centres only. Status: Closed Activation Date: September 28, 2001 , Closing Date: February 17, 2004 Chairs: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911 (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911 (Canada) Dr. Glenwood Goss, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 73132 I154A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With DocetaxelEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: March 06, 2003 , Closing Date: June 28, 2005 Chairs: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746 I178A Phase I Dose-Escalation Study Of JX-963 (Thymidine Kinase/Vaccinia Growth Factor Gene-Deleted Vaccinia Virus Plus GM-CSF) In Patients With Advanced Incurable Solid TumoursEligibility: Locally advanced or metastatic solid tumours refractory to standard curative therapy or for which no curative therapy exists. Prior chemotherapy permitted. Objectives: To explore the intratumoural effects and to determine the recommended phase II dose of JX-963 when administered intravenously over 60 minutes X 2 days (Day 1 and 15) to patients with advanced, incurable solid tumours. Participant: Limited to invited cancer centres only. Status: Closed , Closing Date: April 29, 2011 Chairs: (Canada) Dr. Glenwood Goss, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 73132 I188A Phase I Clinical And Pharmacokinetic Study Of SB939 In Patients With Advanced CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: June 21, 2007 , Closing Date: March 16, 2010 Chairs: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911 I203A Phase I Study of SB939 in Pediatric Patients with Refractory Solid Tumours and Leukemia.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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: September 21, 2010 , Closing Date: January 25, 2012 Chairs: (Canada) Dr. Sylvain Baruchel, Hospital for Sick Children, 1(416) 813-7795 Neuroblastoma 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.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. Participant: Limited to invited cancer centres only. Status: Planned Chairs: (Canada) Dr. Victor Lewis, Alberta Children's Hospital, 1(403) 955-7211 Prostate 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 CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: December 06, 2002 , Closing Date: May 05, 2004 Chairs: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746 Unknown or unspecified malignancy I166This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid TumoursEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: April 04, 2005 , Closing Date: July 10, 2006 Chairs: (Canada) Dr. Gerald Batist, Jewish General Hospital, 1(514) 340-8222 Ext. 5418 I166BThis is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid TumoursEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: June 20, 2006 , Closing Date: March 20, 2008 Chairs: (Canada) Dr. Gerald Batist, Jewish General Hospital, 1(514) 340-8222 Ext. 5418 I177A Phase I Study Of AT7519M Given Twice Weekly In Patients With Advanced Incurable MalignancyEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: August 22, 2006 , Closing Date: April 04, 2011 Chairs: (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 (Canada) Dr. Eric (Xueyu) Chen, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2263 I179Phase 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: October 25, 2006 , Closing Date: March 27, 2009 Chairs: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2818 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 MalignancyEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: January 04, 2007 , Closing Date: November 24, 2009 Chairs: (Canada) Dr. Susan Dent, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70167 (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2032 PHASE I-II STUDIESAcute Myeloid Leukemia 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 MDSEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: July 24, 2007 , Closing Date: December 10, 2009 Chairs: (Canada) Dr. David A. MacDonald, QEII Health Sciences Centre, 1(902) 473-2394 (Canada) Dr. Brian Leber, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 521-2100 Ext. 76384 Brain I170A Phase I/II Study of GW572016 in Patients With Recurrent Malignant GliomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: December 16, 2004 , Closing Date: May 08, 2007 Chairs: (Canada) Dr. Brian Thiessen, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2734 Breast 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 CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: June 03, 2010 , Closing Date: March 05, 2013 Chairs: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2752 Colon 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.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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: May 01, 2012 Chairs: (Canada) Dr. Derek Jonker, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70168 I214A Phase I/II Trials of MF1MA3 With and Without ADVAC/MA3 in Patients With Advanced/Metastatic Colorectal or Non Small Cell Lung Cancer.Eligibility: Objectives: Participant: Limited to invited cancer centres only. Status: Planned Chairs: (Canada) Dr. Derek Jonker, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70168 Lung Cancer - Non-Small Cell I196A Phase I/II Study of Foretinib in Patients with Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy (IND.196)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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: December 17, 2009 , Closing Date: January 24, 2013 Chairs: (Canada) Dr. Natasha Leighl, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-4645 (Canada) Dr. Cheryl Ho, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2445 Lung Cancer - Small Cell (= oat cell) 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.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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: January 30, 2009 , Closing Date: March 10, 2011 Chairs: (Canada) Dr. Peter Ellis, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 Pancreas I173A Phase I/II Study Of AZD0530 In Combination With Gemcitabine In Patients With Advanced Pancreatic CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: July 19, 2005 , Closing Date: May 29, 2008 Chairs: (Canada) Dr. Malcolm Moore, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2263 (Canada) Dr. Sharlene Gill, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2734 PHASE II STUDIESBrain I142A Phase II Study of SarNU (NSC 364432) in Patients With Malignant GliomaEligibility: 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-naïve. 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: January 10, 2002 , Closing Date: December 17, 2002 Chairs: (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, 1(403) 944-1260 I204A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression.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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: December 09, 2010 , Closing Date: September 24, 2012 Chairs: (Canada) Dr. Marshall W. Pitz, CancerCare Manitoba, 1(204) 787-8642 Breast I163A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: January 19, 2005 , Closing Date: January 11, 2007 Chairs: (Canada) Dr. Susan Ellard, BCCA-Cancer Ctr., Southern Interior, 1(250) 712-3922 (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2032 I164A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: June 27, 2005 , Closing Date: September 29, 2006 Chairs: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2752 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.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 Participant: Limited to invited cancer centres only. Status: On Hold Activation Date: May 25, 2010 Chairs: (Canada) Dr. Sasha Lupichuk, Tom Baker Cancer Centre, 1(403) 521-3688 (Canada) Dr. Daniel Rayson, QEII Health Sciences Centre, 1(902) 473-6106 I213A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast CancerEligibility: Patients with histoligical/cytological diagnosis of metastatic breast cancer, that is advances 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, they have received taxane and anthracycline containing adjuvant chemotherapy. ECOG0-2. 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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: July 30, 2012 Chairs: (Canada) Dr. Vanessa Bernstein, BCCA - Vancouver Island Centre, 1(250) 519-5571 (Canada) Dr. Susan Ellard, BCCA-Cancer Ctr., Southern Interior, 1(250) 712-3922 Cervix I184A Phase II Study of Sunitinib, an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients with Unresectable, Locally Advanced or Metastatic Cervical CarcinomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: November 09, 2006 , Closing Date: May 12, 2008 Chairs: (Canada) Dr. Helen J. MacKay, Univ. Health Network-Princess Margaret Hospital, (416) 946-4501 Ext. 2253 I199A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix.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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: December 17, 2009 , Closing Date: October 27, 2011 Chairs: (Canada) Dr. Helen J. MacKay, Univ. Health Network-Princess Margaret Hospital, (416) 946-4501 Ext. 2253 (Canada) Dr. Anna Tinker, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2707 Chronic Lymphocytic Leukemia I193A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: June 21, 2012 Chairs: (Canada) Dr. Matthew D. Seftel, CancerCare Manitoba, 1(204) 787-1250 Colon I146A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: October 30, 2001 , Closing Date: August 14, 2003 Chairs: (Canada) Dr. Ralph P.W. Wong, CancerCare Manitoba, St. Boniface General Hospital, 1(204) 237-2006 I210A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer.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 predictive of response by assessment of archival tumour tissue, including KRAS status. 2d.To explore the Quality of Life (as measured by the EORTC QLQC30) NCT Registration ID (from clinicaltrials.gov): NCT01622543 Participant: Limited to invited cancer centres only. Status: Open Activation Date: June 11, 2012 Chairs: (Canada) Dr. Derek Jonker, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70168 (Canada) Dr. Patricia Tang, Tom Baker Cancer Centre, 1(403) 521-3490 Endometrial (non-sarcomatous uterine c.) I148A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the EndometriumEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: January 10, 2002 , Closing Date: March 16, 2004 Chairs: (Canada) Dr. Anthony Fyles, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-6522 (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2818 I160A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: January 14, 2004 , Closing Date: June 15, 2007 Chairs: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2818 (Canada) Dr. Laurie Elit, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 389-5688 I192A Phase II Study of Ridaforolimus in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: August 26, 2008 , Closing Date: August 11, 2010 Chairs: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2818 Head and Neck I157A 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: February 10, 2003 , Closing Date: September 22, 2004 Chairs: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911 Liver (hepato-cellular) I168A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular CarcinomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: November 24, 2004 , Closing Date: May 04, 2006 Chairs: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2399 (Canada) Dr. Sharlene Gill, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2734 Lung Cancer - Non-Small Cell I211A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: October 15, 2012 Chairs: (Canada) Dr. Donald G. Morris, Tom Baker Cancer Centre, 1(403) 521-3347 Melanoma I169A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients with Metastatic or Recurrent Malignant MelanomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: November 22, 2004 , Closing Date: May 01, 2006 Chairs: (Canada) Dr. Christopher Lee, BC Cancer Agency - Fraser Valley Centre, 1(604) 930-4017 I189A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant MelanomaEligibility: 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 µg/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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: July 10, 2007 , Closing Date: August 17, 2009 Chairs: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, 1(416) 480-5248 I202A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent MelanomaEligibility: 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 ar chival specimens. NCT Registration ID (from clinicaltrials.gov): NCT01152788 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: June 28, 2010 , Closing Date: February 29, 2012 Chairs: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, 1(416) 480-5248 (Canada) Dr. Kerry J. Savage, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2641 Mesothelioma I183A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural MesotheliomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: November 10, 2006 , Closing Date: September 10, 2010 Chairs: (Canada) Dr. Scott Laurie, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70173 I207A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural MesotheliomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: November 30, 2011 Chairs: (Canada) Dr. Paul Wheatley-Price, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 79859 (Canada) Dr. Quincy Chu, Cross Cancer Institute, 1(780) 432-8248 Multiple Myeloma I145A Phase II Study of ZD6474 in Patients With Relapsed Multiple MyelomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: October 02, 2002 , Closing Date: April 08, 2004 Chairs: (Canada) Dr. Michael J. Kovacs, London Health Sciences Centre, 1(519) 685-8500 Ext. 52254 I191A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple MyelomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: June 15, 2010 , Closing Date: July 26, 2012 Chairs: (Canada) Dr. Anthony J. Reiman, Atlantic Health Sciences Corporation, 1(506) 648-6884 Multiple Sites I206A Phase II Study of Sunitinib or Temsirolimus in Patients with Advanced Rare Tumours.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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: July 14, 2011 Chairs: (Canada) Dr. Hal Hirte, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 Non-Hodgkins Lymphoma I150A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell LymphomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: July 04, 2002 , Closing Date: July 28, 2004 Chairs: (Canada) Dr. Andrew Belch, Cross Cancer Institute, 1(780) 432-8757 I152A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's MacroglobulinemiaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: August 27, 2002 , Closing Date: March 23, 2005 Chairs: (Canada) Dr. Christine Chen, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2827 I172Phase 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: June 14, 2006 , Closing Date: September 19, 2008 Chairs: (Canada) Dr. Tom Kouroukis, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 Ext. 62487 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 LymphomaEligibility: - 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: November 08, 2006 , Closing Date: March 24, 2009 Chairs: (Canada) Dr. Rena Buckstein, Odette Cancer Centre, 1(416) 480-5000 Ext. 5847 I194A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell LymphomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: July 24, 2012 Chairs: (Canada) Dr. John Kuruvilla, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2827 Ovary I149A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: January 10, 2002 , Closing Date: June 01, 2004 Chairs: (Canada) Dr. Hal Hirte, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 I185A Phase II Study Of Sunitinib (SU11248; NSC 736511) In Patients With Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal CarcinomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: November 10, 2006 , Closing Date: April 17, 2008 Chairs: (Canada) Dr. James Biagi, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 4503 Prostate 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.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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: June 27, 2005 , Closing Date: December 21, 2006 Chairs: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746 I167Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: June 21, 2004 , Closing Date: December 20, 2005 Chairs: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746 I195A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: February 10, 2010 , Closing Date: November 04, 2011 Chairs: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746 (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2707 I205A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: April 04, 2011 Chairs: (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746 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 CancerEligibility: 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 Participant: Limited to invited cancer centres only. Status: Open Activation Date: June 11, 2012 Chairs: (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2707 Renal (kidney) I161A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell CarcinomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: January 16, 2004 , Closing Date: April 05, 2005 Chairs: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2399 Sarcoma - soft tissue I155A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue SarcomaEligibility: 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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: May 15, 2003 , Closing Date: August 10, 2004 Chairs: (Canada) Dr. Meg Knowling, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2445 I200A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.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 Participant: Limited to invited cancer centres only. Status: Closed Activation Date: March 18, 2010 , Closing Date: January 25, 2012 Chairs: (Canada) Dr. Quincy Chu, Cross Cancer Institute, 1(780) 432-8248 |
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