臨床研究等提出・公開システム

Date of registration	Aug. 18, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220818

Scientific Title	Japan/Korea Joint Phase II Study of Nimotuzumab plus Irinotecan in Patients with Advanced or Recurrent Gastric Cancer
Public Title

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		80
Study Type		Interventional
Study Design	Study Design	Open-label, multicenter, randomized, 2-arm
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Histologically or cytologically confirmed gastric adenocarcinoma. Unresectable or recurrent gastric cancer patients, refractory to 5-fluorouracil-based agents or 5-fluorouracil-containing therapy. Only "one prior regimen" is eligible. ECOG Performance Status is 0-1
	Exclusion Criteria	Patients who previously received irinotecan Patients who previously received EGFR-directed therapy (e.g. cetuximab, erlotinib). Patients with any of the following severe or uncontrolled intercurrent diseases
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Advanced or Recurrent Gastric Cancer Refractory to 5-fluorouracil-containing Regimens
Intervention(s)		investigational material(s) Generic name etc : DE-766 (nimotuzumab) INN of investigational material : nimotuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous drip infusion (400mg weekly)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Progression Free Survival RECIST (ver. 1.0)
Secondary Outcome		Response rate, disease control rate, duration of response, time to progression, time to treatment failure, overall survival, safety, pharmacokinetics RECIST (ver. 1.0), NCI-CTC (ver. 3.0)

Primary Sponsor	DAIICHISANKYO Co.,Ltd.
Secondary Sponsor	KUHNIL PHARM.Co., LTD

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-090849
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
17	Dec. 17, 2018	(this page)	Changes
16	June. 19, 2015	Detail	Changes
15	June. 19, 2015	Detail	Changes
14	May. 16, 2014	Detail	Changes
13	May. 16, 2014	Detail	Changes
12	Dec. 07, 2012	Detail	Changes
11	Dec. 07, 2012	Detail	Changes
10	Aug. 11, 2011	Detail	Changes
9	Aug. 11, 2011	Detail	Changes
8	Jan. 27, 2011	Detail	Changes
7	Jan. 27, 2011	Detail	Changes
6	Sept. 27, 2010	Detail	Changes
5	Sept. 27, 2010	Detail	Changes
4	Feb. 17, 2010	Detail	Changes
3	Feb. 17, 2010	Detail	Changes
2	Aug. 18, 2009	Detail	Changes
1	Aug. 18, 2009	Detail

List of change history