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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site contacts updated at 9 of 10 sitesv12
  2. Minor Site details revised at 1 of 10 sitesv11
  3. Minor Study sites: 9 to 10v10
  4. Minor Study sites: 7 to 9v9
  5. Minor Study sites: 6 to 7v8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Study sites: 5 to 6v7
  2. Minor Study sites: 4 to 5v6
  3. Minor Study sites: 3 to 4v5
  4. Minor Study sites: 2 to 3v4
  5. Minor Study sites: 1 to 2
    • Start date changed from estimate of Nov 2024 to Dec 10, 2024
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06630234
Lead Sponsor Deciphera Pharmaceuticals, LLC
Conditions
(from sponsor)
Gastrointestinal Stromal Tumor (GIST)
Related terms Gastrointestinal Stromal Tumors
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov