A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
Complexity Level: 2
Eligibility: Patients must:(1) be assigned to BRC6B (i.e., defined as PI3K positive after biomarker testing),(2) have a HbAic <7% and fasting glucose < 125 mg/dL,(3) not have Type I or II diabetes that requires anti-hyperglycemic medication,(4) not have active or history of small or large intestine inflammation (eg. Crohn's disease or ulcertive colitis),(5) not require daily supplemental O2,(6) be able to take oral medications. Patients may not have any impairment or gastrointestinal function or disease that may significantly alter absorption of Taselisib-eg. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection,(7) not be taking, or plan to take while on protocol treatment and for 14 days post last dose of study treatment, drugs, herbal supplements, or foods that are known to be strong/moderate CYP3A4 substrates,(8) be offered participation in banking for future use of specimens,(9) see also common eligibility criteria of main BRC6 trial.
Objectives: (1) to evaluate Taselisib (GDC-0032), a PI3K inhibitor, in PI3K-positive patients,(2) within Ph II component of BRC6B, to evaluate if there is sufficient evidence to continue to Ph III,(3) to evaluate investigator-assessed PFS & OS (4)to evaluate ORR,(5) to establish a tissue/blood repository from patients with refractory lung squamous cell carcinoma, (6) to evaluate DOR,(7) to evaluate frequency & severity of toxicities associated with Taselisib,(8) to identify additional predictive tumour/blood biomarkers that may modify response or define resistence to Taselisib,(9) to identify potential resistence biomarkers at PD.
NCT Registration ID (from clinicaltrials.gov): NCT02154490
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 15, 2016 Closing Date: December 13, 2016
Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645