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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 - Trial NCT06252649

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.

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NCT06252649
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06252649
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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)

Study Focus

FOLFIRI Regimen

Interventional

drug

Sponsor & Location

Amgen

Timeline & Enrollment

Phase 3

Apr 30, 2024

Nov 27, 2030

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 colon
Malignant neoplasm: Colon, unspecified
Malignant neoplasm: Descending colon
Malignant neoplasm: Ascending colon
Malignant neoplasm: Overlapping lesion of colon

Data Source

ClinicalTrials.gov

NCT06252649

Non-Device Trial