A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan

Inclusion Criteria:

• Age ≥20 years

• A diagnosis of TGCT (i) that has been histologically confirmed by a pathologist1 and (ii) associated with severe morbidity or functional limitations and not amenable toimprovement with surgery determined consensually by qualified personnel (eg, 2surgeons or a multi-disciplinary tumor board).

• Measurable disease as defined by RECIST version 1.1 (except that a minimal size of 2cm is required), assessed from MRI scan by a central radiologist.

Exclusion Criteria:

• Known metastatic TGCT.

• Pre-existing increased serum transaminases; total bilirubin or direct bilirubin (>upper limit of normal); or active liver or biliary tract disease, includingincreased alkaline phosphatase.

• Significant concomitant arthropathy in the affected joint, serious illness,uncontrolled infection, or a medical or psychiatric history that, in theInvestigator's opinion, would likely interfere with a participant's studyparticipation or the interpretation of his or her results.

• Use of strong cytochrome P450 3A inducers, including St John's wort, proton pumpinhibitors and potassium-competitive acid blockers, or other products known to causehepatotoxicity.