Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors
NCT ID: NCT06948955
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Bezuclastinib
Drug: Bezuclastinib
Sunitinib
Drug: Sunitinib (locally sourced)
Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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.
18 Years
ALL
No
Sponsors
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Cogent Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rachael Easton, MD, PhD
Role: STUDY_DIRECTOR
Cogent Biosciences, Inc.
Locations
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UCLA Department of Medicine- Hematology/Oncology
Los Angeles, California, 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
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
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Sarcoma Center
Role: primary
Cancer Answer Line
Role: primary
Other Identifiers
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CGT9486-EAP-002
Identifier Type: -
Identifier Source: org_study_id
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