The purpose of this expanded access program (EAP) is to provide investigationalbezuclastinib so that it can be coadministered with sunitinib to patients with adiagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactoryalternative therapy options. The combination of bezuclastinib and sunitinib providesbroad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.
Not Provided
Drug: Bezuclastinib
Drug: Bezuclastinib
Drug: Sunitinib
Drug: Sunitinib (locally sourced)
Inclusion Criteria:
- Able to provide written informed consent and commit to recommended EAP assessments.
- ≥18 years of age.
- Able to swallow tablets.
- Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.
- Intolerant to imatinib or received prior imatinib therapy for treatment of advanced,
metastatic, and/or unresectable GIST that resulted in disease progression.
- Meet clinically acceptable local laboratory results.
Exclusion Criteria:
- Patients who are eligible for and capable of participating in and/or enrolled in an
on-going bezuclastinib clinical trial.
- Prior or known intolerance to sunitinib.
- Patients who have previously participated in a bezuclastinib clinical trial.
- Patients with persistent > Grade 2 toxicities from prior therapy.
- Known PDGFR driving mutations or known SDH deficiency.
- Pregnant or currently breastfeeding.
Other protocol-defined criteria apply.
Mayo Clinic Hospital
Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Department of Medicine- Hematology/Oncology
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
Smillow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
Orlando Health
Orlando, Florida, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Dana Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Taylor Cancer Research Center
Maumee, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Alexandra Malinowski, PharmD
1-877-633-8049
EAP@cogentbio.com
Rachael Easton, MD, PhD, Study Director
Cogent Biosciences, Inc.