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Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Jul 2026 to Aug 2028v24
  2. 2 versions Re-verified since Nov 18, 2024, no change to tracked fieldsv22-v23
  3. Primary completion date: Dec 2023 to Jul 2026v21 Show 5 more changesShow less
    • Primary endpoints revised (9)
    • Study completion date: Jun 2024 to Aug 2028
    • Interventions: DCC-3014 (Drug) to Vimseltinib (Drug)
    • Eligibility criteria expanded, about 7 words
    • Study title expanded, about 1 word
  4. Primary completion date: Jul 2022 to Dec 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 24 of 24 sites
    v20
  5. Site details revised at 2 of 24 sitesv19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 22 to 24v18
  2. Primary completion date: Jun 2021 to Jul 2022
    • Study sites: 21 to 22
    • Study completion date: Jun 2023 to Jun 2024
    v17
  3. Study sites: 19 to 21v16
  4. Study sites: 18 to 19
    • Eligibility criteria expanded, about 19 words
    v15
  5. Study sites revised (18)v14
  6. Study sites: 16 to 18v13
  7. Study sites: 12 to 16v12
  8. Site details revised at 7 of 12 sitesv11
  9. Phase: Phase 1 to Phase 1/2v10 Show 8 more changesShow less
    • Primary completion date: Nov 2020 to Jun 2021
    • Primary endpoints revised (9)
    • Enrollment target: 102 to 120
    • Study sites: 10 to 12
    • Study completion date: Nov 2021 to Jun 2023
    • Eligibility criteria expanded, about 334 words
    • Secondary endpoints: 3 to 5
    • Study title expanded, about 5 words
  10. Study sites: 7 to 10v9
  11. Study sites: 6 to 7v8
  12. Site contacts updated at 1 of 6 sitesv7
  13. Primary endpoints: 7 to 9v6 Show 4 more changesShow less
    • Enrollment target: 80 to 102
    • Study sites: 5 to 6
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 5 to 3
  14. Primary completion date: Jan 2019 to Nov 2020v5 Show 7 more changesShow less
    • Primary endpoints revised (7)
    • Enrollment target: 55 to 80
    • Study sites: 3 to 5
    • Study completion date: Aug 2019 to Nov 2021
    • Eligibility criteria shortened, about 1,009 words
    • Secondary endpoints: 1 to 5
    • Study title revised
  15. Primary completion date: Aug 2018 to Jan 2019
    • Study completion date: Feb 2019 to Aug 2019
    v4
  16. Re-verified, no change to tracked fieldsv3
  17. Study sites: 1 to 3v2
  1. 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.
This is a multicenter, open-label Phase 1/2 study of vimseltinib in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.
Trial Details
NCT Number NCT03069469
Lead Sponsor Deciphera Pharmaceuticals, LLC
Conditions
(from sponsor)		 Advanced Malignant Neoplasm, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath, Tenosynovial Giant Cell Tumor, Tenosynovial Giant Cell Tumor, Diffuse
Related terms Giant Cell Tumor of Tendon Sheath, Synovitis, Pigmented Villonodular
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov