Trials / Recruiting
RecruitingNCT06252649
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FOLFIRI Regimen | Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W. |
| DRUG | Sotorasib | Immediate-release solid dosage form administered orally. |
| DRUG | Panitumumab | Administered via IV infusion Q2W. |
| DRUG | Bevacizumab-awwb | Administered via IV infusion Q2W. |
Timeline
- Start date
- 2024-07-17
- Primary completion
- 2028-01-31
- Completion
- 2031-08-31
- First posted
- 2024-02-12
- Last updated
- 2026-04-02
Locations
286 sites across 33 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06252649. Inclusion in this directory is not an endorsement.