CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 40 enrolled / 40 target
Drug / intervention
Pexidartinibdrug
Likely dose
Pexidartinib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04488822
NCT04488822Phase 3ActiveUpdate Overdue (0.6/mo)Completion was 56mo ago
CompareCT.gov

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

Daiichi Sankyo Co., Ltd.·interventional·Posted Jul 28, 2020·Updated Jun 26, 2026

In Brief

A Phase 3 clinical trial evaluating Pexidartinib for Tenosynovial Giant Cell Tumor. Active but no longer recruiting, targeting 40 participants across 9 sites in 2 countries.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTenosynovial Giant Cell Tumor
CountriesChina, Taiwan
Collaborators--

Timeline

Phase 3Active
2021202220232024202520262027
First PostedJul 28, 2020
Enrollment StartSep 25, 2020
Primary CompletionOct 27, 2021
Study CompletionMar 31, 2027
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.9 years ago

Arms & Interventions

Pexidartinibexperimental

Drug: Pexidartinib

Interventions

Pexidartinibdrug

400 mg twice daily for a total daily dose of 800 mg (each capsule contains 200 mg of pexidartinib for oral administration)