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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllDeciphera Pharmaceuticals, LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • DCC-3009
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Where

10 sites
HonorHealth
Scottsdate, United States
UC San Diego Moores Cancer Center
La Jolla, United States
University of Colorado Anschutz Medical Campus
Aurora, United States
Mayo Clinic Florida
Jacksonville, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, United States
Dana Farber Cancer Institute
Boston, United States
START Midwest
Grand Rapids, United States
Mayo Clinic Rochester
Rochester, United States

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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