drugset / Trial / NCT04703322

A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan

NCT04703322

Phase 2 Completed 9 enrolled Daiichi Sankyo
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-03-15
Primary completion
2023-03-20
Completion
2026-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Pexidartinib Small molecule 400 mg Oral