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ACTIVE NOT RECRUITING
NCT04703322
PHASE2

A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan

Sponsor: Daiichi Sankyo Co., Ltd.

View on ClinicalTrials.gov

Summary

This phase 2, multicenter, two-part, open-label, single-arm study will be conducted in Japan and will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of pexidartinib in adult participants with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitation and not amenable to improvement with surgery.

Official title: A Phase 2, Multicenter, Two-Part, Open-Label Study of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor in Japan

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2021-03-15

Completion Date

2026-05-31

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

Pexidartinib

400 mg twice daily for a total daily dose of 800 mg (each capsule contains 200 mg of pexidartinib for oral administration)

Locations (6)

Nagoya University Hospital

Aichi, Japan

Kyushu University Hospital

Fukuoka, Japan

Kanazawa University Hospital

Ishikawa, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Osaka International Cancer Institute

Osaka, Japan

National Cancer Center Hospital

Tokyo, Japan