Status:
ACTIVE_NOT_RECRUITING
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Advanced Colorectal Cancer
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setti...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
- Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.
Exclusion
- Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
- Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
- Active brain metastasis
Key Trial Info
Start Date :
June 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2026
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT04793958
Start Date
June 24 2021
End Date
January 30 2026
Last Update
February 11 2025
Active Locations (419)
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1
Local Institution - 010-855-E
Alabaster, Alabama, United States, 35007
2
Local Institution - 010-855-B
Bessemer, Alabama, United States, 35022
3
Local Institution - 010-855-D
Birmingham, Alabama, United States, 35209
4
Local Institution - 010-855-A
Birmingham, Alabama, United States, 35211