臨床研究等提出・公開システム

Date of registration	Aug. 09, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221193

Scientific Title	Phase 1 study of CS-7017 in combination with FOLFIRI in subjects with Metastatic colorectal cancer(CRC)who failed First-line therapy
Public Title	Phase 1 study of CS-7017 in combination with FOLFIRI

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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		21
Study Type		Interventional
Study Design	Study Design	Open Label Phase 1 Study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Histologically or cytologically diagnosed CRC. -Metastatic CRC who failed First-line therapy. -Measurable disease(RECIST Ver.1.1). -Male or female>=20 years of age. -ECOG performance status: 0-1. etc.
	Exclusion Criteria	-First-line treatment with an CPT-11-based regimen. -History of any of the following events within 6 months prior to start of study treatment myocardial infraction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or cerebral infraction, pulumonary embolizm, deep vein thrombosis, or other clinically significant thromboembolic event, clinically significant pulmonary disease (eg severe COPD or asthma) -Patient with a clinically active brain metastasis, or who need drugs to control adverse event like edema and pleural effusion -Diarrhea, inflammatory bowel disease, or bow obstruction etc.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Metastatic CRC who failed First-line therapy
Intervention(s)		investigational material(s) Generic name etc : CS-7017 INN of investigational material : efatutazone Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : CS-7017(0.25-0.50 mg) administered orally twice a day
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety and Pharmacokinetics -To evaluate the safety profile according to CTCAE -To evaluate the pharmacokinetics according to the protocol
Secondary Outcome		-Determination of the recommended dose -Preliminary anti-tumor effect of CS-7017/FOLFIRI -Preliminary biomarker study of CS-7017 -To study potential biomarker of CS-7017 activity according to the protocol -To evaluate anti-tumor effect according to RECIST

Primary Sponsor	DAIICHISANKYO 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-101230
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Mar. 26, 2013	Detail	Changes
7	Mar. 26, 2013	Detail	Changes
6	Feb. 15, 2012	Detail	Changes
5	Feb. 15, 2012	Detail	Changes
4	Jan. 27, 2011	Detail	Changes
3	Jan. 27, 2011	Detail	Changes
2	Aug. 09, 2010	Detail	Changes
1	Aug. 09, 2010	Detail

List of change history