NCT04488822

A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT

Multicenter, Single Arm Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess pexidartinib in adult participants with symptomatic TGCT that is associated with severe morbidity or functional limitations and not amendable to improvement with surgery.

Detailed description

Participants with symptomatic TGCT will be administered pexidartinib 400 mg twice daily continuously with 28-day treatment cycle until criteria for discontinuation are reached. Participants who complete primary endpoint assessments may be eligible to continue receiving pexidartinib until disease progression, unacceptable toxicity, the occurrence of other termination criteria, or withdrawal from the study. Eligible participants' status will be collected every 6 months as a long term follow-up at least 2 years.

Conditions

• Tenosynovial Giant Cell Tumor

Interventions

Type	Name	Description
DRUG	Pexidartinib	400 mg twice daily for a total daily dose of 800 mg (each capsule contains 200 mg of pexidartinib for oral administration)

Timeline

• Start date: 2020-09-25
• Primary completion: 2021-10-27
• Completion: 2026-02-28
• First posted: 2020-07-28
• Last updated: 2025-09-09
• Results posted: 2023-04-27

Locations

9 sites across 2 countries: China, Taiwan

Regulatory

• FDA-regulated drug study