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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

To evaluate the safety and tolerability of sotorasib administered in investigational regimens
in adult participants with KRAS p.G12C mutant advanced solid tumors.
Miscellaneous, Phase I
Phase I
Adults
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
ABX-EGF, AMG 404, AMG 510, Afatinib, Atezolizumab, BI 1701963, Carboplatin, Docetaxel (Taxotere), Everolimus, FOLFIRI (Leucovorin, 5-FU, Irinotecan), MK-3475, Paclitaxel, Palbociclib, Panitumumab, Pembrolizumab (MK-3475), Pemetrexed, RMC-4630, Sotorasib, TNO155, Trametinib
Iams, Wade
National
Vanderbilt University
12-02-2020
Treatment
VICCPHI2025
NCT04185883

Eligibility

18 Years
BOTH
NO
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 performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.



Exclusion Criteria:

Primary brain tumor.

Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.

Myocardial infarction within 6 months of study day 1.

Gastrointestinal (GI) tract disease causing the inability to take oral medication.

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