Tenosynovial Giant Cell Tumor Clinical Trial
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
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04488822 -
A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT
|
Phase 3 | |
Active, not recruiting |
NCT01207492 -
Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor
|
Phase 2 | |
Terminated |
NCT04938180 -
A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients
|
Phase 2 | |
Completed |
NCT04526704 -
Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
|
Phase 4 | |
Active, not recruiting |
NCT05059262 -
Study of Vimseltinib for Tenosynovial Giant Cell Tumor
|
Phase 3 | |
Active, not 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 |
NCT04635111 -
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIOâ„¢ (Pexidartinib) Treatment
|
||
Recruiting |
NCT05349643 -
A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT
|
Phase 2 | |
Recruiting |
NCT04192344 -
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
|
Phase 1 | |
Terminated |
NCT02673736 -
A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Giant Cell Tumor
|
Phase 1 | |
Active, not recruiting |
NCT03069469 -
Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
|
Phase 1/Phase 2 | |
Terminated |
NCT01804530 -
Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT05804045 -
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
|
Phase 3 |