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Completed
NCT03600883
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 (CodeBreaK 100)
Conditions: KRAS p.G12C Mutant Advanced Solid Tumors
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 713
Sponsor: Amgen
Location: City of Hope National Medical Center Duarte California
Summary
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Eligibility Criteria
Inclusion Criteria:
* Men or women greater than or equal to 18 years old.
* Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
Exclusion Criteria
* Active brain metastases from non-brain tumors.
* Myocardial infarction within 6 months of study day 1.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Source: ClinicalTrials.gov (NCT03600883). StuddyBuddy aggregates publicly available trial information.
