臨床研究等提出・公開システム

Date of registration	Oct. 05, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221605

Scientific Title	A Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of TAS-115 in Patients with Advanced Solid Tumors.
Public Title	Phase I Study of TAS-115 in Patients with Advanced Solid Tumors

Completion Date or Terminated date
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
Plan description
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	toiawaseCD1@taiho.co.jp
	Phone Number
	E-mail Address

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

Recruitment Status

Date of First Enrolment
Target Sample Size		85
Study Type		Interventional
Study Design	Study Design	Open-label, single-center, phase I study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Signed, written informed consent. - Histologically or cytologically confirmed solid tumor. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
	Exclusion Criteria	- Investigational drug therapy within 28 days prior to enrollment. - Radiotherapy within 21 days prior to enrollment. - Received extensive prior radiotherapy on more than 30% of bone marrow. - Females who are pregnant or breastfeeding. - Serious complications.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Patients with advanced solid tumor
Intervention(s)		investigational material(s) Generic name etc : TAS-115 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : The starting dose of TAS-115 will be 100 mg/body/day given orally by once a day, twice a day or three times a day in patients with advanced solid tumors.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety CTCAE (ver.4.03)
Secondary Outcome		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

Name of IRB	National Cancer Center Institutional Review Board
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-111645
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Dec. 06, 2013	Detail	Changes
7	Dec. 06, 2013	Detail	Changes
6	Aug. 02, 2013	Detail	Changes
5	Aug. 02, 2013	Detail	Changes
4	Nov. 01, 2012	Detail	Changes
3	Nov. 01, 2012	Detail	Changes
2	Oct. 05, 2011	Detail	Changes
1	Oct. 05, 2011	Detail

List of change history