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A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT — PLX3397  

Tenosynovial Giant Cell Tumor Clinical Trial

Official title:
Multicenter, Single Arm Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor

Clinical Trial Summary

This study will assess pexidartinib in adult participants with symptomatic TGCT that is associated with severe morbidity or functional limitations and not amendable to improvement with surgery.

Clinical Trial Description

Participants with symptomatic TGCT will be administered pexidartinib 400 mg twice daily continuously with 28-day treatment cycle until criteria for discontinuation are reached. Participants who complete primary endpoint assessments may be eligible to continue receiving pexidartinib until disease progression, unacceptable toxicity, the occurrence of other termination criteria, or withdrawal from the study. Eligible participants' status will be collected every 6 months as a long term follow-up at least 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04488822
Study type Interventional
Source Daiichi Sankyo
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 25, 2020
Completion date February 28, 2026
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
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Recruiting NCT05349643 - A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT Phase 2
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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