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A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan
Sponsor: Daiichi Sankyo Co., Ltd.
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
Conditions
Interventions
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