This is a blinded Phase 2 study designed to evaluate the safety and efficacy of inavolisib with bevacizumab and chemotherapy, in participants with metastatic colorectal cancer (mCRC) whose tumors have a PIK3CA mutation. The study has a safety run-in period followed by a randomized period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Participants will receive Inavolisib as per the schedule mentioned in the protocol.
Participants will receive Bevacizumab as per the schedule mentioned in the protocol.
Participants will receive FOLFOX as per the schedule mentioned in the protocol.
Safety Run-in Period: Percentage of Participants With Adverse Events (AEs)
Time frame: Approximately 4 Years
Percentage of Participants With an Objective Response Rate
The percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1.)
Time frame: From Baseline Untill Radiographic Disease Progression (Approximately 4 Years)
Progression-free Survival (PFS)
Time from randomization to death from any cause or the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 (whichever occurs first)
Time frame: From Baseline Untill Radiographic Disease Progression (up to Approximately 4 Years)
Randomized Phase: Overall Survival (OS)
Defined as the time from randomization to death from any cause
Time frame: From Baseline Untill Death (up to Approximately 4 Years)
Randomized Phase: Disease Control Rate (DCR)
Defined as the percentage of participants with stable disease for \>=12 weeks or a CR or PR as determined by the investigator according to RECIST v1.1
Time frame: From Baseline Untill Disease Progression (up to Approximately 4 Years)
Randomized Phase: Duration of Response (DOR)
Defined as the time from the first occurrence of a documented confirmed OR to death from any cause or the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, (whichever occurs first)
Time frame: From Baseline Untill Disease Progression or Death (up to Approximately 4 Years)
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Participants will receive FOLFIRI as per the schedule mentioned in the protocol.
Participants will receive Placebo as per the schedule mentioned in the protocol.
Randomized Phase: Percentage of Participants With AEs
Time frame: From Baseline up to 90 Days After the Final Dose of study treatment or Until Initiation of Another Anti-cancer Therapy (up to Approximately 4 Years)
Percentage of Participants With Symptomatic Treatment Toxicities as Assessed by National Cancer Institute Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)
Time frame: Up to Approximately 4 Years
Percentage of Participants Troubled by Treatment Symptoms, as Assessed by Single Item European Organisation for Research and Treatment of Cancer Item Library 46 (EORTC IL46)
Time frame: Up to Approximately 4 Years
Change From Baseline in Symptomatic Treatment Toxicities as Assessed by PRO-CTCAE
Time frame: Baseline up to Approximately 4 Years
Change From Baseline in Treatment Side-effect Bother as Assessed by EORTC IL46 item
Time frame: Baseline up to Approximately 4 Years