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A Phase 4, Multicenter Study to Evaluate Discontinuation and Re-Treatment in Subjects With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
Daiichi Sankyo, Inc.
To be eligible for this trial, potential participants must be enrolled in one of the following studies: Currently enrolled and on pexidartinib treatment in one of the following studies: Study PLX108-10 (ENLIVEN), Study PLX108-01, Study PL3397-A-A103 or Study PL3397-A-U126. Investigators and participants will be given the option (at screening) to either continue pexidartinib treatment (Treatment Continuation Cohort) or discontinue treatment with the possibility of re-initiating pexidartinib treatment (Treatment-Free/Re-Treatment Cohort). Previously-treated participants in the 'Treatment Continuation Cohort' will continue their current dose of pexidartinib treatment (at an oral dose of 200 mg, administered twice daily on an empty stomach).