Status:
ACTIVE_NOT_RECRUITING
A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Tenosynovial Giant Cell Tumor
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 pa...
Detailed Description
This study will consist of 2 parts. In Part 1, pexidartinib 800 mg/day (400 mg twice a day \[BID\]) will be administered on an empty stomach and tolerability and PK of pexidartinib will be evaluated t...
Eligibility Criteria
Inclusion
- Age ≥20 years
- 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).
- 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
- Known metastatic TGCT.
- 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.
- 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.
- 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.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2026
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04703322
Start Date
March 15 2021
End Date
May 31 2026
Last Update
March 3 2025
Active Locations (6)
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1
Nagoya University Hospital
Aichi, Japan, 466-8560
2
Kyushu University Hospital
Fukuoka, Japan, 812-8582
3
Kanazawa University Hospital
Ishikawa, Japan, 920-8641
4
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006