臨床研究等提出・公開システム

Date of registration	Dec. 05, 2019
Last modified on	Aug. 20, 2024
Trial ID	jRCT2080224975

Scientific Title	A Phase 1b Study to Assess the Safety, Tolerability, and Efficacy of TAS-120 (Futibatinib) in Combination with MK-3475 (Pembrolizumab) in Patients with Solid Tumors (MK3475 - 990)
Public Title	A Phase 1b Study of TAS-120 and Pembrolizumab

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Taiho Pharmaceutical Co., Ltd.
	Address	1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo
	Phone Number	+81-3-3293-2113
	E-mail Address	th-TAS120-info@taiho.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Taiho Pharmaceutical Co., Ltd.
	Address	1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo
	Phone Number	+81-3-3293-2113
	E-mail Address	toiawase@taiho.co.jp

Recruitment Status	completed

Date of First Enrolment		Feb. 04, 2020
Target Sample Size		207
Study Type		Interventional
Study Design	Study Design	phase 1b, open-label, nonrandomized, multicenter study
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Be willing and able to provide written informed consent for the trial. Able to take medications orally. Have a measurable disease per RECIST 1.1 Have adequate organ function value Is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other protocol procedures Feasibility phase Have histologically confirmed advanced or metastatic solid tumors Be positive for FGF/FGFR abnormalities Expansion phase Have histologically confirmed advanced or metastatic esophageal carcinoma or non-small cell lung cancer Have mRNA of FGFR 1, 2, 3, or 4 overexpression in tumor tissue sample (non-small cell lung cancer)
	Exclusion Criteria	Have a serious illness or medical conditions. Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to futibatinib and any drug similar to futibatinib in structure or class
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Patients with advanced or metastatic esophageal carcinoma or non-small-cell lung cancer
Intervention(s)		investigational material(s) Generic name etc : futibatinib INN of investigational material : futibatinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Not determine, once daily, orally, in a 21 day-cycle control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety efficacy Safety, Efficacy
Secondary Outcome		safety efficacy Safety, Efficacy

Primary Sponsor	Taiho Pharmaceutical Co., Ltd.
Secondary Sponsor	Merck Sharp & Dohme Corp.

Name of Funding Organization	Taiho Pharmaceutical Co., Ltd.
Name of Research Funding	Clinical Trial of Taiho

Name of IRB	National Cancer Ctr IRB #2-J
Address of IRB	5-1-1, Tsukiji, Chuo-ku, Tokyo
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Nov. 27, 2019

Secondary ID No.	JapicCTI-195063
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
10	Aug. 20, 2024	(this page)	Changes
9	Oct. 17, 2023	Detail	Changes
8	Aug. 05, 2023	Detail	Changes
7	Aug. 05, 2022	Detail	Changes
6	Feb. 03, 2022	Detail	Changes
5	Feb. 10, 2021	Detail	Changes
4	Aug. 06, 2020	Detail	Changes
3	Feb. 03, 2020	Detail	Changes
2	Dec. 10, 2019	Detail	Changes
1	Dec. 05, 2019	Detail

List of change history