臨床研究等提出・公開システム

Date of registration	June. 10, 2019
Last modified on	Mar. 04, 2026
Trial ID	jRCT1080224720

Scientific Title	TR research associated with 'A multicenter Phase II basket-type clinical trial to evaluate efficacy and safety of TAS-120 in patients with advanced solid malignancies with FGFR alterations in circulating tumor DNA (TiFFANY study)'
Public Title	TiFFANY TR

Contact for Scientific Queries	Name	YOSHINO TAKAYUKI
	Contact Name for Scientific Queries	National Cancer Center Hospital East
	Address	6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
	Phone Number	+81-4-7133-1111
	E-mail Address	TiFFANY_core@east.ncc.go.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	National Cancer Center Hospital East
	Address	6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
	Phone Number	+81-4-7133-1111
	E-mail Address	TiFFANY_core@east.ncc.go.jp

Recruitment Status	completed

Date of First Enrolment		June. 17, 2019
Target Sample Size		26
Study Type		Observational
Study Design	Study Design	-
Study Design	Objective	other
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Patients enrolled in treatment group in 'A multicenter Phase II basket-type clinical trial to evaluate efficacy and safety of TAS-120 in patients with advanced solid malignancies with FGFR alterations in circulating tumor DNA(TiFFANY study)'
	Exclusion Criteria	-
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		solid malignancies
Intervention(s)		investigational material(s) Generic name etc : TAS-120 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : - 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		other Immunohistochemistry In situ hybridization Reverse Phase Protein Array Targeted sequencing RNA-seq Digital sequencing of ctDNA (Guardant360) Functional analysis (in vitro and in vivo)
Secondary Outcome		other -

Primary Sponsor	National Cancer Center Hospital East
Secondary Sponsor	National Cancer Center, Aichi Cancer Center Research Institute

Name of Funding Organization	Taiho Pharmaceutical Co., Ltd
Name of Research Funding	Biomarker research expenses

Name	Ethics Review Board of National Cancer Center Hospital East for TR study
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Phone Number	+81-3-3542-2511
E-mail Address	irst@ml.res.ncc.go.jp
Status of Review	Approval
Date of Approval	June. 13, 2019

Secondary ID No.	JapicCTI-194796
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	Mar. 04, 2026	(this page)	Changes
5	April. 11, 2022	Detail	Changes
4	Mar. 26, 2021	Detail	Changes
3	July. 13, 2020	Detail	Changes
2	Aug. 02, 2019	Detail	Changes
1	June. 14, 2019	Detail

List of change history