Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
Public ClinicalTrials.gov record NCT02371369. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects With Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02371369
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 11, 2015 (Actual)
- Primary completion
- Mar 27, 2017 (Actual)
- Completion
- Apr 30, 2021 (Actual)
- Last update posted
- May 11, 2022
2015 – 2021
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259-5499 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Stanford Cancer Center | Palo Alto | California | 94305 | — |
| UCLA Medical Center | Santa Monica | California | 90404 | — |
| Mayo Clinic Cancer Center | Jacksonville | Florida | 32224 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| : Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| MD Anderson Cancer Center at Cooper | Camden | New Jersey | 08103 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Duke Cancer Center | Durham | North Carolina | 27710 | — |
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02371369, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 11, 2022 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02371369 live on ClinicalTrials.gov.