Actively Recruiting
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Led by Deciphera Pharmaceuticals, LLC · Updated on 2026-02-05
120
Participants Needed
10
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.
CONDITIONS
Official Title
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
Module A Part 1 (Escalation):
- 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
You will not qualify if you...
- Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug
- 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
AI-Screening
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Trial Site Locations
Total: 10 locations
1
HonorHealth
Scottsdate, Arizona, United States, 85258
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
8
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
10
Vanderbilt University-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
C
Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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