A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib With Bevacizumab Plus Folfox or Folfiri as First Line Therapy in Patients With PIK3CA-Mutated Metastatic Colorectal Cancer
Sponsor: Hoffmann-La Roche
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Safety Run-in Period: Percentage of Participants With Adverse Events (AEs)
Time frame: Approximately 4 Years
Percentage of Participants With an Objective Response Rate
Time frame: From Baseline Untill Radiographic Disease Progression (Approximately 4 Years)
Secondary Endpoints
Progression-free Survival (PFS)
Randomized Phase: Overall Survival (OS)
Randomized Phase: Disease Control Rate (DCR)
Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) \<=1 * Histologically confirmed adenocarcinoma originating in the colon or rectum of the Stage 4 ( treatment plan does not include resection or curative ablation) per American Joint Committee on Cancer (AJCC) v8 * Measurable disease per RECIST v1.1 * No prior systemic therapy in the metastatic setting * Confirmation of biomarker eligibility: documentation of a PIK3CA mutation from either central testing of tissue, or from a validated historically obtained (pre-existing) test of tumor tissue or blood may be used to confirm eligibility * Adequate hematologic and organ function within 14 days prior to initiation of study treatment * Agreement to adhere to the contraception requirements Exclusion Criteria: * Biomarker eligibility as per definition * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry or any history of Type 1 diabetes * Residual Grade 2 or higher neuropathy due to prior oxaliplati…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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