A Randomized Phase 3 Study of Adagrasib in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy
Phase 3
- Conditions
- Colon cancer10017991
- Registration Number
- NL-OMON54310
- Lead Sponsor
- Mirati Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 7
Inclusion Criteria
1. Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C
mutation in tumor tissue.
2. Prior receipt of 1st line treatment in the 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
1. Prior treatment with both an oxaliplatin-and irinotecan-based regimen for
CRC, concurrently or successively, in any setting (neoadjuvant, adjuvant or
advanced)
2. Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG
510).
3. Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Progression-Free Survival (PFS), and<br /><br>• Overall Survival (OS).</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Safety characterized by type, incidence, severity, timing, seriousness and<br /><br>relationship to study treatment of adverse events, laboratory abnormalities,<br /><br>and number of patients discontinuing study treatment due to an adverse event.<br /><br>• Secondary efficacy endpoints:<br /><br>*- Objective Response Rate (ORR),<br /><br>*- Duration of Response (DOR), and<br /><br>*- 1-Year Survival Rate.<br /><br>• Plasma PK parameters of Adagrasib (and metabolites, if applicable).<br /><br>• Patient reported outcome (PROs) scores using the following:<br /><br>- European Organization for Research and Treatment of Cancer (EORTC) Quality of<br /><br>Life Questionnaire for Cancer Patients (QLQ-C30).<br /><br>- European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).</p><br>