A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
NCT ID: NCT06630234
Last Updated: 2025-11-19
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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RECRUITING
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2024-12-10
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DCC-3009 Module A
Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation and Part 2 dose expansion.
DCC-3009
Administered orally
Interventions
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DCC-3009
Administered orally
Eligibility Criteria
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Inclusion Criteria
* Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation, who has progressed on or was intolerant to at least 1 approved tyrosine kinase inhibitor (TKI) regimen in the advanced/metastatic setting
* Have at least 1 measurable lesion as defined by mRECIST, v1.1
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
* Adequate organ function, bone marrow function, and electrolytes
* All participants agree to comply with the contraception requirements
* Have a life expectancy of more than 3 months
Exclusion Criteria
* Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer
* Has known active central nervous system (CNS) metastases or an active primary CNS cancer
* History or presence of clinically relevant cardiovascular abnormalities
* Major surgery within 28 days of the first dose of study drug
* Had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug
* Had venous thrombotic events (e.g., deep vein thrombosis) or venous thrombotic embolic events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug
* Known allergy or hypersensitivity to any component of the study drug
* Malabsorption syndrome or other illness that could affect oral absorption
* Any other clinically significant comorbidities
18 Years
ALL
No
Sponsors
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Deciphera Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team
Role: STUDY_DIRECTOR
Deciphera Pharmaceuticals, LLC
Locations
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HonorHealth
Scottsdate, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Vanderbilt University-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Other Identifiers
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DCC-3009-01-001
Identifier Type: -
Identifier Source: org_study_id
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