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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: Active Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, sponsored by Deciphera Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ORR was assessed by blinded independent radiologic review (IRR) using RECIST Version 1.1. ORR was defined as the percentage of participants who achieved either complete response (CR) or partial response (PR). * CR: Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in short axis. Non-nodal targets must be absent. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2028-07 |
| Phase | Phase 3 |
What the registry record for NCT05059262 still lists
NCT05059262 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, above the 102-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (21% higher).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Tenosynovial Giant Cell Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05059262's enrollment target sits among peer trials
123 2nd of 8 the highest of 8 other Tenosynovial Giant Cell Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tenosynovial Giant Cell Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
ACTIVE NOT RECRUITING · Phase 3
-
Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
COMPLETED · Phase 3
-
Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib
RECRUITING
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
RECRUITING · Phase 1
-
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
RECRUITING
-
Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
ACTIVE NOT RECRUITING · Phase 1
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