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NCT06252649

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)
Amgen·Phase 3·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Metastatic Colorectal Cancer
Drug/Device/Intervention
FOLFIRI Regimen
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Amgen
Timeline & enrollment
Phase
Phase 3
Start date
Apr 30, 2024
End date
Nov 27, 2030
Enrollment
450 participants
Primary outcome

PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

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.

ICD-10 classifications
Malignant neoplasm of colonMalignant neoplasm: Colon, unspecifiedMalignant neoplasm: Descending colonMalignant neoplasm: Ascending colonMalignant neoplasm: Overlapping lesion of colon
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06252649
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06252649 through Pure Global AI's free database. This Phase 3 trial is sponsored by Amgen and is currently Not yet recruiting. The study focuses on Metastatic Colorectal Cancer. Target enrollment is 450 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.