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Active Not Recruiting
NCT04793958
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
Conditions: Advanced Colorectal Cancer, Metastatic Colorectal Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 461
Sponsor: Mirati Therapeutics Inc.
Location: Local Institution - 010-855-E Alabaster Alabama
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 setting in patients with CRC with KRAS G12C mutation.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT04793958). StuddyBuddy aggregates publicly available trial information.
