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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)
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)

NCT03600883

CompletedPhase 1, Phase 2

Sponsor: Amgen

Conditions: KRAS p.G12C Mutant Advanced Solid Tumors

Interventions: sotorasib, Anti PD-1/L1, Midazolam

Countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (133)
  • Duarte, California, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Denver, Colorado, United States
  • New Haven, Connecticut, United States
  • Newark, Delaware, United States
  • Gainesville, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Bethesda, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • St Louis, Missouri, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Cleveland, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Spartanburg, South Carolina, United States
  • Nashville, Tennessee, United States
  • + 103 more on CT.gov