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Brief Title: A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan
Official Title: A Phase 2, Multicenter, Two-Part, Open-Label Study of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor in Japan
Study ID: NCT04703322
Brief 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.
Detailed Description: This study will consist of 2 parts. In Part 1, pexidartinib 800 mg/day (400 mg twice a day \[BID\]) will be administered on an empty stomach and tolerability and PK of pexidartinib will be evaluated to determine the initiation of Part 2. In Part 2, pexidartinib 800 mg/day (400 mg BID) will be administered on an empty stomach and efficacy, safety, and PK of pexidartinib will be evaluated.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR