Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutatio

Phase 1

• Conditions: Advanced Colorectal Cancer with KRAS G12C Mutation; MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004048-27-AT
• Lead Sponsor: Mirati Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-27
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210

Exclusion Criteria

- Prior treatment with both an oxaliplatin-and irinotecan-based regimen for CRC, concurrently or successively, in any setting (neoadjuvant, adjuvant or advanced).
- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified