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

About

Brief Summary

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
100 Years

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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Study Stats
Protocol No.
20-000382
Category
Bladder Cancer
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Gallbladder Cancer
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Melanoma (Skin Cancer)
Non-Melanoma Skin Cancer
Other Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Sarcoma
Stomach Cancer
Uterine/Endometrial Cancer
Contact
Shenetra Walker
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04185883
For detailed technical eligibility, visit ClinicalTrials.gov.