For Healthcare Professionals

A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Age ≥20 years
  2. A diagnosis of TGCT (i) that has been histologically confirmed by a pathologist1 and (ii) associated with severe morbidity or functional limitations and not amenable to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board).
  3. Measurable disease as defined by RECIST version 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist.

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Known metastatic TGCT.
  2. Pre-existing increased serum transaminases; total bilirubin or direct bilirubin (>upper limit of normal); or active liver or biliary tract disease, including increased alkaline phosphatase.
  3. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator's opinion, would likely interfere with a participant's study participation or the interpretation of his or her results.
  4. Use of strong cytochrome P450 3A inducers, including St John's wort, proton pump inhibitors and potassium-competitive acid blockers, or other products known to cause hepatotoxicity.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +81-3-6225-1111(M-F 9-5 JST)Email iconEmail Study Center

Study Details


Contition

Tenosynovial Giant Cell Tumor

Age

20+

Phase

PHASE2

Participants Needed

21

Est. Completion Date

Nov 30, 2026

Treatment Type

INTERVENTIONAL


Sponsor

Daiichi Sankyo

ClinicalTrials.gov NCT Identifier

NCT04703322

Study Number

PL3397-A-J304

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