jRCT2071240009RecruitingNot Applicable
Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naive Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Amgen K.K.
- Enrollment
- 450
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
- •Central confirmation of KRAS p.G12C mutation
- •Measurable metastatic disease per RECIST v1.1 criteria.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of <=
- •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 pulmonary fibrosis on baseline CT scan
Investigators
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