臨床研究等提出・公開システム

Date of registration	Sept. 15, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220861

Scientific Title	Phase 1 Study of CS-1008 - Evaluation of Safety and Pharmacokinetics of CS-1008 in Japanese Patients With Solid Cancer
Public Title	Phase 1 Study of CS-1008

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 COMPANY, LIMITED
	Address	http://www.daiichisankyo.co.jp/contact/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		15
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 metastatic solid cancers which are not curable with, or not eligible for standard treatment(s) ECOG performance status: 0-1
	Exclusion Criteria	Patients with a clinically active brain metastasis, or who need drugs like steroid to control edemas Patients with diarrhea (grade 2) Inflammatory bowel disease, or partial bowel obstruction Patients with pleural effusion or ascites effusion that requires drainage Patients with history of myocardial infarction or cerebral infarction within 6 months Patients with any severe or uncontrolled intercurent diseases
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Solid Cancer not curable with, or not eligible for standard treatment(s)
Intervention(s)		investigational material(s) Generic name etc : Tigatuzumab (CS-1008) INN of investigational material : Tigatuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : intravenous infusion
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		Anti-CS-1008 antibodies Determination of the recommended Phase 2 dose Preliminary anti-tumor effect of CS-1008 Preliminary biomarker study of CS-1008 To characterize the immunogenicity of CS-1008 by monitoring for anti-CS-1008 antibodies To study potential biomarker of CS-1008 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-090892
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
8	Dec. 17, 2018	(this page)	Changes
7	Feb. 07, 2011	Detail	Changes
6	Oct. 27, 2010	Detail	Changes
5	Oct. 27, 2010	Detail	Changes
4	April. 20, 2010	Detail	Changes
3	April. 20, 2010	Detail	Changes
2	Sept. 15, 2009	Detail	Changes
1	Sept. 15, 2009	Detail

List of change history