Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
| Inavolisib | Drug | Inavolisib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + Inavolisib
- description
- Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Inavolisib.
- interventionNames
- Drug: Inavolisib
- Drug: Bevacizumab
- Drug: FOLFOX
- Drug: FOLFIRI
- type
- PLACEBO_COMPARATOR
- label
- Randomized Period: FOLFOX or FOLFIRI + Bevacizumab + Placebo
- description
- Participants will receive either FOLFOX or FOLFIRI and Bevacizumab along with Placebo.
- interventionNames
- Drug: Bevacizumab
- Drug: FOLFOX
- Drug: FOLFIRI
- Drug: Placebo
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available