Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
Sponsor: Mirati Therapeutics Inc.
Sponsor score: 40
ClinicalTrials ID:NCT04793958
This Phase 3 trial evaluates MRTX849 with cetuximab against chemotherapy in advanced colorectal cancer patients with KRAS G12C mutation. Eligible participants must have progressed after first-line fluoropyrimidine-based chemotherapy. Interventions include MRTX849, cetuximab, mFOLFOX6, and FOLFIRI regimens, each administered in 28-day cycles.
Patient Parameters
| Parameter | Options |
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Program Overview
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 010-855-E | 35007 | Alabaster | Alabama |
| Local Institution - 010-855-B | 35022 | Bessemer | Alabama |
| Local Institution - 010-855-D | 35209 | Birmingham | Alabama |
| Local Institution - 010-855-A | 35211 | Birmingham | Alabama |
| Local Institution - 010-855-F | 35235 | Birmingham | Alabama |
| Local Institution - 010-855-C | 35243 | Birmingham | Alabama |
| Local Institution - 010-855 | 35243 | Birmingham | Alabama |
| Local Institution - 010-996 | 85234 | Gilbert | Arizona |
| Local Institution - 010-566 | 85338 | Goodyear | Arizona |
| Local Institution - 010-989 | 85054 | Phoenix | Arizona |
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