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)
Trial Status: Active
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.
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.
California
Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Ruth Gonzalez
Phone: 310-794-4376
Email:
rngonzalez@mednet.ucla.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email:
cancertrials@ucsf.edu
Connecticut
New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Florida
Tampa
Moffitt Cancer Center
Status: ACTIVE
Georgia
Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Indiana
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Kati Lyn Dendler
Phone: 317-278-6475
Email:
kdendler@iu.edu
Massachusetts
Boston
Brigham and Women's Hospital
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE
New York
Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
North Carolina
Durham
Duke University Medical Center
Status: ACTIVE
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Pennsylvania
Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Thomas Jefferson University Hospital
Status: ACTIVE
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Tennessee
Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Texas
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
M D Anderson Cancer Center
Status: ACTIVE
Utah
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Washington
Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Trial Phase Phase I/II
Trial Type Treatment
Lead Organization
Amgen, Inc.
- Primary ID 20170543
- Secondary IDs NCI-2018-01725
- Clinicaltrials.gov ID NCT03600883