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Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

Tenosynovial Giant Cell Tumor Clinical Trial

Official title:
A Multi-Center Single Agent Phase II Study of the Efficacy of Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

Clinical Trial Summary

Nilotinib is a drug that is used to treat a form of a blood cancer called leukemia. Nilotinib works by blocking the action of a protein that might be important for the growth of pigmented villonodular synovitis (PVNS). In this research study the investigators are testing whether nilotinib can stop the growth of PVNS or improve the symptoms experienced from PVNS.

Clinical Trial Description

- In this research study, each cycle of study drug dosing will last 4 weeks (28 days). During each cycle, participants will take nilotinib by mouth twice daily. During the first cycle, participants will come to the clinic on Days 1 and 8. For Cycles 2-4 and every 3 cycles thereafter, they will come to the clinic on Day 1. - The following tests and procedures will be performed at specific time points during study treatment: MRI or CT scans; physical examinations; vital signs; blood work; questionnaires and EKG. - Participants may continue in this research study for as long as they do not have serious side effects or their disease does not get worse. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01207492
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 2010
Completion date January 2025
View Details
See also
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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
Completed NCT02371369 - Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) Phase 3
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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 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