NCT04526704

Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib

A Phase 4, Multicenter Study to Evaluate Discontinuation and Re-Treatment in Subjects With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the discontinuation/re-treatment of pexidartinib therapy in previously treated participants with tenosynovial giant cell tumor (TGCT).

Detailed description

This multicenter study in previously pexidartinib-treated participants with TGCT will provide the Investigators and participants the option at Screening to either continue pexidartinib treatment (Treatment Continuation Cohort) or discontinue treatment with the possibility of re-initiating pexidartinib treatment (Treatment-Free/Re-Treatment Cohort).

Conditions

• Tenosynovial Giant Cell Tumor

Interventions

Type	Name	Description
DRUG	Pexidartinib	200 mg capsules administered orally twice daily on an empty stomach (at least 1 hour before or at least 2 hours after a meal or snack)

Timeline

• Start date: 2020-10-20
• Primary completion: 2023-07-07
• Completion: 2023-07-07
• First posted: 2020-08-26
• Last updated: 2024-12-30
• Results posted: 2024-12-30

Locations

16 sites across 7 countries: United States, Australia, Hungary, Italy, Netherlands, Spain, Taiwan

Regulatory

• FDA-regulated drug study