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Study of Vimseltinib for Tenosynovial Giant Cell Tumor

Study acronym: MOTION
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Study completion date: Jul 2026 to Jul 2028v16
  2. Results first posted: Feb 24, 2025
    • Secondary endpoints: details revised at 1 of 6 entries
    v15
  3. Primary endpoint revisedv14 Show 4 more changesShow less
    • Enrollment target: estimated 120 to confirmed 123
    • Interventions: Placebo (Drug), vimseltinib (Drug) to Placebo (Drug), Vimseltinib (Drug)
    • Secondary endpoints revised (6)
    • Eligibility criteria expanded, about 1 word
  4. Re-verified, no change to tracked fieldsv13
  5. Primary completion date changed from estimate of Mar 2024 to Aug 10, 2023v12
Show 10 earlier versionsHide 10 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 35 of 35 sites
    v11
  2. Study sites: 34 to 35v10
  3. Study sites: 32 to 34v9
  4. Study sites: 25 to 32v8
  5. Study sites: 22 to 25v7
  6. Study sites: 20 to 22v6
  7. Study sites: 18 to 20v5
  8. Study sites: 22 to 18
    • Eligibility criteria shortened, about 32 words
    v4
  9. Study sites: 14 to 22v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 11 to 14
    • Start date changed from estimate of Sep 2021 to Oct 14, 2021
    • Study title shortened, about 2 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.
Trial Details
NCT Number NCT05059262
Lead Sponsor Deciphera Pharmaceuticals, LLC
Conditions
(from sponsor)		 Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Localized
Related terms Giant Cell Tumor of Tendon Sheath, Synovitis, Pigmented Villonodular
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov