A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation.
Phase 1
Completed
- Conditions
- KRAS p.G12C Mutant Advanced Solid Tumors
- Registration Number
- JPRN-jRCT2080224746
- Lead Sponsor
- Amgen K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 793
Inclusion Criteria
1. Men or women greater than or equal to 18 years old.
2. Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
Exclusion Criteria
1. Active brain metastases from non-brain tumors.
2. Myocardial infarction within 6 months of study day 1.
3. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method