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NCT02371369 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
A Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT02371369: Completed Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, sponsored by Daiichi Sankyo.
NCT02371369 is a Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis that has completed, run by Daiichi Sankyo. The registered enrollment target is 120 participants, above the 103-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02371369, a Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called pexidartinib for the treatment of certain tumors for which surgical removal could cause more harm than good. The main purpose of this study is to gather information about the investigational drug pexidartinib, which may help to treat tumors of pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS). The study consists of two parts with a follow-up period. In Part 1, eligible study participants will be assigned to receive either pexidartinib 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. Some subjects, assigned to placebo in Part 1 transitioned to pexidartinib for Part 2. Then a protocol amendment was written to allow only pexidartinib patients to continue into Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label pexidartinib. There was also a follow-up period added to Part 2.
Primary Outcome
Complete response (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pexidartinib
Study Locations (20)
California
- University of Southern California - Los Angeles
- Stanford Cancer Center - Palo Alto
- UCLA Medical Center - Santa Monica
Florida
- Mayo Clinic Cancer Center - Jacksonville
- Sylvester Comprehensive Cancer Center - Miami
- Moffitt Cancer Center - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- : Dana Farber Cancer Institute - Boston
Arizona
- Mayo Clinic - Scottsdale
Michigan
- Michigan Comprehensive Cancer Center - Ann Arbor
Minnesota
- Mayo Clinic Cancer Center - Rochester
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- MD Anderson Cancer Center at Cooper - Camden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2015-05-11 |
| Est. Completion | 2021-04-30 |
| Phase | Phase 3 |
What the finished NCT02371369 record still lists
NCT02371369 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 103-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (17% higher).
The record links to 3 conditions, with Tenosynovial Giant Cell Tumor appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02371369 names 20 study sites across 15 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02371369 about?
NCT02371369 is a clinical study titled "Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)". This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called pexidartinib for the treatment of certain tumors for which surgical removal could cause more harm than good. The main purpose of this study is to gather information about the investigational...
What is the current status of trial NCT02371369?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2015-05-11. Estimated completion is 2021-04-30.
What conditions does trial NCT02371369 study?
This clinical trial studies the following conditions: Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumors of the Tendon Sheath.
What interventions are being tested in trial NCT02371369?
The interventions under investigation include: Placebo (DRUG), Pexidartinib (DRUG).
Who is sponsoring clinical trial NCT02371369?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02371369 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02371369's enrollment target sits among peer trials
120 3rd of 8 higher than 5 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
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Study of Vimseltinib for Tenosynovial Giant Cell Tumor
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Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
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