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- INAVO-CRC
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
Cancer Colorectal Cancer (CRC)
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Study Identifier
NCT07323576, WO46300, 2025-523014-84-00
Condition
Colorectal Cancer
Official Title
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
Study Summary
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 Criteria
All
≥18 Years
No
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com