臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 15, 2020
Last modified on	July. 12, 2023
Trial ID	jRCT2041200074

Scientific Title	A phase 2, multicenter, two-part, open-label study of pexidartinib in adult subjects with tenosynovial giant cell tumor in Japan
Public Title	Japan Ph2 Study of Pexidartinib in TGCT

Contact for Scientific Queries	Name	Inoguchi Akihiro
	Affiliation	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	DAIICHI SANKYO Co.,Ltd.
	Address	1-2-58, Hiromachi, Shinagawa-ku, Tokyo
	Telephone	+81-3-6225-1111
	E-mail	dsclinicaltrial@daiichisankyo.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 18, 2020
Actual date of first enrollment		Mar. 15, 2021
Target sample size		21
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- 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.
	Exclusion Criteria	- 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.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Tenosynovial giant cell tumor
Intervention(s)		pexidartinib 400 mg twice a day, oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Part 1: Dose-limiting toxicity, pharmacokinetics parameters Part 2: Objective response rate
Secondary Outcome(s)		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)

Primary Sponsor	DAIICHI SANKYO Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Certified Review Board, Kanazawa University
Address	13-1 Takaramachi, Kanazawa, Ishikawa
Telephone	+81-76-265-2048
E-Mail	hpsangak@adm.kanazawa-u.ac.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	July. 12, 2023	(this page)	Changes
4	May. 02, 2022	Detail	Changes
3	April. 12, 2021	Detail	Changes
2	Feb. 09, 2021	Detail	Changes
1	Dec. 15, 2020	Detail

List of change history