A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)
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.
Arms & interventions
- DrugDCC-3009
Administered orally
Outcome measures
Primary
Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
DLTs assessed for each dose level.
Time frame: Cycle 1 (28 Days)
Objective Response Rate (ORR) (Part 2 Expansion)
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.
Time frame: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Secondary
Objective Response Rate (ORR) (Part 1 Escalation)
Time frame: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Duration of Response (DOR)
Time frame: First Recorded CR or PR until PD or Death (Estimated up to 24 months)
Progression-Free Survival (PFS)
Time frame: Initiation of Treatment to PD or Death (Estimated up to 24 months)
Overall Survival (OS)
Time frame: Initiation of Treatment to Death from Any Cause (Estimated up to 24 months)
Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax)
Time frame: Estimated up to 24 months
Eligibility criteria
Study locations (10)
HonorHealth
Scottsdate, Arizona, 85258
UC San Diego Moores Cancer Center
La Jolla, California, 92093
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
START Midwest
Grand Rapids, Michigan, 49546
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Vanderbilt University-Ingram Cancer Center
Nashville, Tennessee, 37232