Japan Ph2 Study of Pexidartinib in TGCT

Phase 2

Recruiting

• Conditions: Tenosynovial giant cell tumor

• Registration Number: JPRN-jRCT2041200074
• Lead Sponsor: Inoguchi Akihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-15
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 21

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 to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board).
- Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm 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 (>ULN); or active liver or biliary tract disease, including increased ALP.
- Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator`s opinion, would likely interfere with a subject`s study participation or the interpretation of his or her results.
- Use of strong cytochrome P450 3A inducers, including St John's wort, proton pump inhibitors and potassium-competitive acid blockers, or other products known to cause hepatotoxicity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified