Actively Recruiting
Phase 12 Study of Oral DCC-3009 for Advanced Gastrointestinal Stromal Tumor GIST Evaluating Safety and Effectiveness in Patients with KIT or PDGFRA Mutations
Led by Deciphera Pharmaceuticals, LLC · Updated on 2026-02-05
120
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating DCC-3009, an oral drug, for its safety, tolerability, and effectiveness in treating Gastrointestinal Stromal Tumor GIST. This Phase 12 master protocol study uses a modular design where each module tests DCC-3009 alone or with other anticancer therapies. The study includes dose escalation and dose expansion phases to explore different doses and effects. Participants receive DCC-3009 in 28-day treatment cycles. Module A includes a Part 1 dose escalation phase to determine safe dosing, followed by a Part 2 dose expansion phase to further study the drugs effects. The estimated treatment duration for participants is up to 2 years. During the study, participants will be closely monitored for dose-limiting toxicities and tumor response using imaging and clinical assessments. Researchers will measure outcomes such as objective response rate, duration of response, progression-free survival, overall survival, and drug concentration in the blood. Safety and treatment effects will be assessed over an estimated 24 months of follow-up.
CONDITIONS
Brief Title
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Research Team
C
Clinical Team
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