臨床研究等提出・公開システム

Japanese

Date of registration	May. 28, 2014
Last modified on	Aug. 20, 2021
Trial ID	jRCT2080222501

Scientific Title	A PHASE I, OPEN-LABEL, NON-RANDOMIZED, DOSE-ESCALATING, SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC AND EFFICACY STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS,
Public Title	Phase I Study of TAS-120 in Patients with Advanced Solid Tumors

Completion Date or Terminated date	June. 30, 2021
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html.
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Taiho Pharmaceutical Co., Ltd.
	Address	-
	Phone Number	-
	E-mail Address	th-TAS120-info@taiho.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Taiho Pharmaceutical Co., Ltd.
	Address	-
	Phone Number	-
	E-mail Address	toiawase@taiho.co.jp

Recruitment Status	completed

Date of First Enrolment		July. 01, 2014
Target Sample Size		142
Study Type		Interventional
Study Design	Study Design	This is an open-label, non-randomized, dose-escalation, phase 1 study.
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1. Provided written informed consent for treatment. 2. 20 years of age or older at enrollment. 3. Histologically or cytologically confirmed advanced or metastatic solid tumor(s) without standard treatment remains. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient's allocation.
	Exclusion Criteria	1. A serious illness or medical conditions. 2. Known hypersensitivity to any drugs similar to TAS-120 in structure or class. 3. Pregnant or lactating female or women of child-bearing potential who have a positive pregnancy test (urine or serum) within 7 days prior to starting the study drug.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Patients with advanced solid tumors
Intervention(s)		investigational material(s) Generic name etc : TAS-120 Covalent FGFR (fibroblast growth factor receptor) inhibitor INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : TAS-120 will be administered orally Three times per week (TIW) (Monday-Wednesday-Friday). In Dose Level 1 (starting dose), at least 1 patient will receive 8 mg/body of TAS-120. The maximum dose level is defined as Dose Level 10, 240 mg/body. Based on safety, PK and pharmacodynamic results, the dosing schedule may be changed to a once daily (QD) regimen. 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 Safety CTCAE (ver.4.03)
Secondary Outcome		efficacy pharmacokinetics Pharmacokinetics, Efficacy RECIST (ver.1.1)

Primary Sponsor	Taiho Pharmaceutical Co., Ltd.
Secondary Sponsor	-

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

Name of IRB	National Cancer Center Institutional Review Board
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	June. 04, 2014

Secondary ID No.	JapicCTI-142552
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
21	Aug. 20, 2021	(this page)	Changes
20	Feb. 16, 2021	Detail	Changes
19	Aug. 06, 2020	Detail	Changes
18	Feb. 03, 2020	Detail	Changes
17	July. 30, 2019	Detail	Changes
16	Feb. 20, 2019	Detail	Changes
15	Dec. 17, 2018	Detail	Changes
14	Dec. 10, 2018	Detail	Changes
13	Dec. 10, 2018	Detail	Changes
12	Feb. 05, 2018	Detail	Changes
11	Feb. 05, 2018	Detail	Changes
10	Aug. 09, 2016	Detail	Changes
9	Aug. 09, 2016	Detail	Changes
8	Feb. 19, 2016	Detail	Changes
7	Feb. 19, 2016	Detail	Changes
6	Aug. 05, 2015	Detail	Changes
5	Aug. 05, 2015	Detail	Changes
4	July. 02, 2014	Detail	Changes
3	July. 02, 2014	Detail	Changes
2	May. 28, 2014	Detail	Changes
1	May. 28, 2014	Detail

List of change history