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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2031-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + Inavolisib

Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Inavolisib.

Group Type EXPERIMENTAL

Inavolisib

Intervention Type DRUG

Participants will receive Inavolisib as per the schedule mentioned in the protocol.

Bevacizumab

Intervention Type DRUG

Participants will receive Bevacizumab as per the schedule mentioned in the protocol.

FOLFOX

Intervention Type DRUG

Participants will receive FOLFOX as per the schedule mentioned in the protocol.

FOLFIRI

Intervention Type DRUG

Participants will receive FOLFIRI as per the schedule mentioned in the protocol.

Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + Placebo

Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Placebo.

Group Type PLACEBO_COMPARATOR

Bevacizumab

Intervention Type DRUG

Participants will receive Bevacizumab as per the schedule mentioned in the protocol.

FOLFOX

Intervention Type DRUG

Participants will receive FOLFOX as per the schedule mentioned in the protocol.

FOLFIRI

Intervention Type DRUG

Participants will receive FOLFIRI as per the schedule mentioned in the protocol.

Placebo

Intervention Type DRUG

Participants will receive Placebo as per the schedule mentioned in the protocol.

Safety Run-in Period: FOLFOX or FOLFIRI + Bevacizumab + Inavolisib

Participants will receive either FOLFIRI or FOLFOX and Bevacizumab along with Inavolisib.

Group Type EXPERIMENTAL

Inavolisib

Intervention Type DRUG

Participants will receive Inavolisib as per the schedule mentioned in the protocol.

Bevacizumab

Intervention Type DRUG

Participants will receive Bevacizumab as per the schedule mentioned in the protocol.

FOLFOX

Intervention Type DRUG

Participants will receive FOLFOX as per the schedule mentioned in the protocol.

FOLFIRI

Intervention Type DRUG

Participants will receive FOLFIRI as per the schedule mentioned in the protocol.

Interventions

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Inavolisib

Participants will receive Inavolisib as per the schedule mentioned in the protocol.

Intervention Type DRUG

Bevacizumab

Participants will receive Bevacizumab as per the schedule mentioned in the protocol.

Intervention Type DRUG

FOLFOX

Participants will receive FOLFOX as per the schedule mentioned in the protocol.

Intervention Type DRUG

FOLFIRI

Participants will receive FOLFIRI as per the schedule mentioned in the protocol.

Intervention Type DRUG

Placebo

Participants will receive Placebo as per the schedule mentioned in the protocol.

Intervention Type DRUG

Other Intervention Names

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Itovebi GDC-0077 Avastin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No