Japanease

Dec. 15, 2020

April. 12, 2021

jRCT2041200074

A phase 2, multicenter, two-part, open-label study of pexidartinib in adult subjects with tenosynovial giant cell tumor in Japan

Japan Ph2 Study of Pexidartinib in TGCT

Inoguchi Akihiro

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Mar. 15, 2021

21

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

none

- 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 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist.

- Known metastatic TGCT.
- Pre-existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including increased ALP.
- 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 subject`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.

20age old over
No limit

Both

Tenosynovial giant cell tumor

pexidartinib 400 mg twice a day, oral administration

Part 1: Dose-limiting toxicity, pharmacokinetics parameters
Part 2: Objective response rate

Part 1, Part 2: Treatment-emergent adverse events (TEAEs) and other safety parameters during the study
Part 2: Tumor volume score, Range of motion, Patient-Reported Outcomes Measurement Information System (PROMIS) physical function scale,Brief Pain Inventory (BPI)

Recruiting

DAIICHI SANKYO Co.,Ltd.
Certified Review Board, Kanazawa University
13-1 Takaramachi, Kanazawa, Ishikawa

+81-76-265-2048

hpsangak@adm.kanazawa-u.ac.jp
Approval

Nov. 11, 2020

No