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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05059262
Study type Interventional
Source Deciphera Pharmaceuticals LLC
Contact Clinical Team
Phone 785-830-2100
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date September 2021
Completion date July 2026

See also
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Recruiting NCT04526704 - Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib Phase 4
Completed NCT02371369 - Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) Phase 3
Recruiting NCT04731675 - An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee Phase 2
Recruiting NCT04703322 - A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan Phase 2
Completed NCT02471716 - Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor Phase 1/Phase 2
Recruiting NCT04938180 - A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients Phase 2
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Terminated NCT02673736 - A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Giant Cell Tumor Phase 1
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Terminated NCT01804530 - Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors Phase 1