Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Amgen
Summary
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. * Central laboratory detection of KRAS p.G12C mutation. * Measurable metastatic disease per RECIST v1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. * Adequate organ function. Exclusion Criteria: * Active, untreated brain metastases. * Leptomeningeal disease * Previous treatment with a KRAS p.G12C inhibitor * History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonar…
Interventions
- DrugFOLFIRI Regimen
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
- DrugSotorasib
Immediate-release solid dosage form administered orally.
- DrugPanitumumab
Administered via IV infusion Q2W.
- DrugBevacizumab-awwb
Administered via IV infusion Q2W.
Locations (286)
- Ironwood Cancer and Research Centers ScottsdaleChandler, Arizona
- Providence Saint Jude Medical CenterFullerton, California
- City of Hope National Medical CenterLong Beach, California
- Cancer and Blood Research Center, LLCLos Alamitos, California
- California Research InstituteLos Angeles, California
- Norwalk HospitalNorwalk, Connecticut