A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT
← catalyst calendarSponsored by Daiichi Sankyo Co., Ltd. (industry) · 4568.T — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
40actual
Sites
9
Countries
China, Taiwan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-09-25 | actual | When the study began enrolling |
| Primary completion | 2021-10-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2020-07-28 | actual | When this record first appeared on the registry |
| Results posted | 2023-04-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Tenosynovial Giant Cell Tumor
Intervention
- Drug: Pexidartinib — also filed as TURALIO™, PLX3397
Primary outcome
what the primary-completion date above is the date OFOverall Response Rate (ORR) of Pexidartinib Based on RECIST 1.1 of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25
measured At Week 25 postdose
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2021-01-29 · 1.4 MB · Prot_SAP_000.pdf
Publications
- PMID 40841499 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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