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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

NCT07323576

WithdrawnPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Colorectal Cancer

Interventions: Inavolisib, Bevacizumab, FOLFOX, FOLFIRI, Placebo

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 oxaliplatin exposure (unless the participant is planned to be treated with FOLFIRI)
* Symptomatic, untreated, or actively progressing CNS metastases
* History of gastrointestinal (GI) fistula, GI perforation, or intra-abdominal abscess within 6 months prior to Day 1 of Cycle 1
* Treatment with strong cytochrome P450 (CYP) 3A4 inducers or strong CYP3A4 inhibitors within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment (only for patients who will receive FOLFIRI)
* Known HIV positive status with exceptions for well controlled and on stable treatment
* History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death