NCT02371369

Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pigmented Villonodular Synovitis
• Giant Cell Tumors of the Tendon Sheath
• Tenosynovial Giant Cell Tumor

Interventions

Type	Name	Description
DRUG	Pexidartinib	Each capsule contains 200 mg of pexidartinib for oral administration
DRUG	Placebo	Placebo capsule matching pexidartinib capsule for oral administration

Timeline

• Start date: 2015-05-11
• Primary completion: 2017-03-27
• Completion: 2021-04-30
• First posted: 2015-02-25
• Last updated: 2022-05-11
• Results posted: 2020-01-10

Locations

39 sites across 12 countries: United States, Australia, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom