Clinical Trial

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

Study acronym: PLX3397
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2020-07-24; most recent amendment 2026-06-02.
Status change: Recruiting → Active, Not Recruiting 2021-05-26
Status change: Not Yet Recruiting → Recruiting 2020-10-06
Trial Details
NCT Number NCT04488822
Lead Sponsor Daiichi Sankyo Co., Ltd.
Conditions Tenosynovial Giant Cell Tumor
Enrollment 40 participants
Start Date 2020-09-25
Primary Completion 2021-10-27 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-26