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ACTIVE NOT RECRUITING Phase 3

Study of Vimseltinib for Tenosynovial Giant Cell Tumor

NCT05059262 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG Vimseltinib

Study Locations (20)

Other

  • Chris O'Brien Lifehouse — Camperdown
  • McGill University — Montreal
  • Princess Margaret Hospital — Toronto
  • Institut Bergonié — Bordeaux
  • Centre Léon Bérard — Lyon
  • Institut Gustave Roussy — Villejuif
  • Helios Klinikum Berlin-Buch — Berlin
  • University Hospital Essen (Universitätsklinikum Essen) — Essen
  • Prince of Wales Hospital — Hong Kong

California

  • City of Hope — Duarte
  • UC Davis Comprehensive Cancer Center — Sacramento

Colorado

  • University of Colorado — Aurora

Kansas

  • University of Kansas — Kansas City

Massachusetts

  • Dana Farber Cancer Institute — Boston

Minnesota

  • Mayo Clinic Rochester — Rochester

New York

  • Memorial Sloan-Kettering Cancer Center — New York

North Carolina

  • Duke Sarcoma Research — Durham

Trial Details

FieldValue
Enrollment Target 123 participants
Start Date 2021-10-14
Est. Completion 2028-07
Phase Phase 3

Sponsor

Deciphera Pharmaceuticals

42 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05059262

The ClinicalTrials.gov registry entry for NCT05059262 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Deciphera Pharmaceuticals, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Tenosynovial Giant Cell Tumor appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05059262 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05059262 about?

NCT05059262 is a clinical study titled "Study of Vimseltinib for Tenosynovial Giant Cell Tumor". 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, e...

What is the current status of trial NCT05059262?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2021-10-14. Estimated completion is 2028-07.

What conditions does trial NCT05059262 study?

This clinical trial studies the following conditions: Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Localized. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05059262?

The interventions under investigation include: Placebo (DRUG), Vimseltinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05059262?

This trial is sponsored by Deciphera Pharmaceuticals, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05059262 being conducted?

This trial has 20 study locations across California, Colorado, Kansas, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial