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NCT05059262 · ClinicalTrials.gov registry record · Phase 3

Study of Vimseltinib for Tenosynovial Giant Cell Tumor

A Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, sponsored by Deciphera Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
123
Enrollment target
20
Study locations

NCT05059262 is a Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis that is active but no longer recruiting, run by Deciphera Pharmaceuticals. The registered enrollment target is 123 participants, above the 102-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT05059262, a Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, is active but no longer recruiting, sponsored by Deciphera Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
123 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Tenosynovial Giant Cell Tumor Pigmented Villonodular Synovitis Giant Cell Tumor of Tendon Sheath Tenosynovial Giant Cell Tumor, Diffuse Tenosynovial Giant Cell Tumor, Localized

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

21 total trials

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What the Registry Record Tells You About NCT05059262

The ClinicalTrials.gov registry entry for NCT05059262 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 102-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (21% higher). The listed sponsor is Deciphera Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.

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.

NCT05059262 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Colorado.

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.

What interventions are being tested in trial NCT05059262?

The interventions under investigation include: Placebo (DRUG), Vimseltinib (DRUG).

Who is sponsoring clinical trial NCT05059262?

This trial is sponsored by Deciphera Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.