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NCT06630234PHASE1, PHASE2Recruiting

A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)

Deciphera Pharmaceuticals, LLC

Start Date

12/10/2024

Completion Date

5/1/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 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 Exclusion Criteria: * 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

Interventions

DRUG

DCC-3009

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Conditions

Gastrointestinal Stromal Tumor (GIST)

Locations

HonorHealth

Scottsdate, Arizona 85258

United States

UC San Diego Moores Cancer Center

La Jolla, California 92093

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

START Midwest

Grand Rapids, Michigan 49546

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Vanderbilt University-Ingram Cancer Center

Nashville, Tennessee 37232

United States