A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Giant Cell Tumor of Tendon Sheath
Giant Cell Tumors
Tenosynovial Giant Cell Tumor

Clinical Trial Details

NCT number	NCT04703322
Study type	Interventional
Source	Daiichi Sankyo, Inc.
Contact	Daiichi Sankyo Contact for Clinical Trial Information
Phone	+81-3-6225-1111(M-F 9-5 JST)
Email	dsclinicaltrial@daiichisankyo.co.jp
Status	Recruiting
Phase	Phase 2
Start date	March 15, 2021
Completion date	November 30, 2026

View Details

See also
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Terminated	`NCT04938180` - A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients	Phase 2
Completed	`NCT04526704` - Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib	Phase 4
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