CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled / 9 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/NCT04703322
NCT04703322Phase 2CompletedUpdate Overdue (0.1/mo)Completion was 39mo ago
CompareCT.gov

A Phase 2, Multicenter, Two-Part, Open-Label Study of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor in Japan

Daiichi Sankyo Co., Ltd.·interventional·Posted Jan 11, 2021·Updated Jun 24, 2026

In Brief

A Phase 2 clinical trial evaluating Pexidartinib for Tenosynovial Giant Cell Tumor. Completed, enrolled 9 participants across 6 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTenosynovial Giant Cell Tumor
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 11, 2021
Enrollment StartMar 15, 2021
Primary CompletionMar 20, 2023
Study CompletionMay 15, 2026
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.5 years ago

Arms & Interventions

Pexidartinibexperimental

Participants with TGCT who will receive oral pexidartinib 800 mg (400 mg twice daily \[BID\]).

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)