NCT05059262

Study of Vimseltinib for Tenosynovial Giant Cell Tumor

A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Deciphera Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	Vimseltinib	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2021-10-14
• Primary completion: 2023-08-10
• Completion: 2028-07-01
• First posted: 2021-09-28
• Last updated: 2026-03-20
• Results posted: 2025-02-24

Locations

35 sites across 13 countries: United States, Australia, Canada, France, Germany, Hong Kong, Italy, Netherlands, Norway, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study