臨床研究等提出・公開システム

Date of registration	Dec. 13, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221670

Scientific Title	Phase I/II trial of YHI-1003 plus Capecitabine in Patients with Refractory Advanced Colorectal Cancer
Public Title	Phase I/II trial of YHI-1003 plus Capecitabine

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Yakult Honsha Co., Ltd.
	Address	TEL: +81-3-5550-8968, FAX: +81-3-3248-5502
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		50
Study Type		Interventional
Study Design	Study Design	open-label, multicenter trial
Study Design	Objective
Phase		1-2
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Patients with recurrent or metastatic colorectal cancer (2)Patients must have failed available therapy for the treatment of advanced colorectal cancer. (3)No prior exposure to capecitabine and S-1 (4)ECOG performance status (PS) :0-1
	Exclusion Criteria	(1)Patients with uncontrolled intercurrent illness (2)Female patients who are pregnant or lactating (3)Patients with known central nervous system CNS metastases
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Refractory Advanced Colorectal Cancer
Intervention(s)		investigational material(s) Generic name etc : YHI-1003 INN of investigational material : Perifosine Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety CTCAE v4.0
Secondary Outcome		efficacy and pharmacokinetic profile RECIST ver1.1

Primary Sponsor	Yakult Honsha Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
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-111712
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
6	Dec. 17, 2018	(this page)	Changes
5	Mar. 27, 2013	Detail	Changes
4	Mar. 27, 2013	Detail	Changes
3	Jan. 27, 2012	Detail	Changes
2	Dec. 15, 2011	Detail	Changes
1	Dec. 13, 2011	Detail

List of change history