A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)
Deciphera Pharmaceuticals, LLC
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * A…
Interventions
- DrugDCC-3009
Administered orally
Locations (10)
- HonorHealthScottsdate, Arizona
- UC San Diego Moores Cancer CenterLa Jolla, California
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Mayo Clinic FloridaJacksonville, Florida
- University of Miami - Sylvester Comprehensive Cancer CenterMiami, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts