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

Part of paid clinical trials in Scottsdate, Arizona.

Sponsor
Deciphera Pharmaceuticals, LLC
Study ID
NCT06630234
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Gastrointestinal Stromal Tumor (GIST)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DCC-3009 — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
Dec 10, 2024
Status verified
Nov 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DCC-3009 Module A
    Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation and Part 2 dose expansion.

Primary Outcome Measure

Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation) [ Time Frame: Cycle 1 (28 Days) ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdateArizona85258
Program Management
[email protected]
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of Colorado Anschutz Medical CampusAuroraColorado80045
Steven Sares
[email protected]
303-724-9889
Mayo Clinic FloridaJacksonvilleFlorida32224
Caroline Teeter
[email protected]
904-953-5141
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Leah Anton, ARNP
[email protected]
305-243-2529
Dana Farber Cancer InstituteBostonMassachusetts02215
Research Nurse
617-632-5204
START MidwestGrand RapidsMichigan49546
Mayo Clinic RochesterRochesterMinnesota55905
Jordan Meyers
[email protected]
507-284-2030
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Ping Chi, MD
[email protected]
646-888-4166
Vanderbilt University-Ingram Cancer CenterNashvilleTennessee37232
Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
[email protected]
800-811-8480

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By research site
HonorHealth· Scottsdate, AZUC San Diego Moores Cancer Center· La Jolla, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COMayo Clinic Florida· Jacksonville, FLUniversity of Miami - Sylvester Comprehensive Cancer Center· Miami, FLDana Farber Cancer Institute· Boston, MA

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