Amgen2021: Advanced Solid Tumors with KRAS p.G12C Mutation

What is the Purpose of this Study?

We are doing this study to compare how safe and effective different drug combinations are for treating metastatic cancer.

What is the Condition Being Studied?

Colorectal Adenocarcinoma with KRAS p.G12C Mutation

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with advanced or metastatic colorectal adenocarcinoma with KRAS p.G12C mutation
  • Have not received any previous therapy for metastatic disease

For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

  • Get a random assignment (like a coin flip) to 1 of 2 groups
    • One group will get the study drug combination of sotorasib, panitumumab, and FOLFIRI
    • The other group will get FOLFIRI either on its own or with another drug called bevacizumab-awwb
  • Have a tumor biopsy done, if necessary
  • Have blood draws
  • Have imaging scans (CT or MRI)

Study Details

Full Title
Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib,
Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for
Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00114638
NCT: NCT06252649
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL