A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Condition(s) studied
Investigational drug(s) / intervention(s)
DCC-3009: Administered orally
Study 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
Primary outcome measure(s)
- Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation) — Cycle 1 (28 Days)
DLTs assessed for each dose level. - Objective Response Rate (ORR) (Part 2 Expansion) — Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST), v1.1.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth | Scottsdate | Arizona | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | Recruiting |
| University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| START Midwest | Grand Rapids | Michigan | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Vanderbilt University-Ingram Cancer Center | Nashville | Tennessee | Recruiting |
More Deciphera Pharmaceuticals, LLC trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06630234 on ClinicalTrials.gov ↗ ← All trials in the USA