臨床研究等提出・公開システム

Date of registration	May. 31, 2011
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221467

Scientific Title	Phase 1b study of U3-1287 in combination with erlotinib in subjects with advanced non-small cell lung cancer (NSCLC)
Public Title	Phase 1b study of U3-1287 in combination with erlotinib in subjects with advanced non-small cell lung cancer (NSCLC)

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		36
Study Type		Interventional
Study Design	Study Design	Open-label, Phase 1b Study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Histologically or cytologically diagnosed advanced NSCLC has progressed on at least one prior chemotherapy -Stage IIIB or IV disease -Measurable tumour lesions and malignant lymph nodes per RECIST ver 1.1 -ECOG performance status: 0-1
	Exclusion Criteria	-Has history of erlotinib or anti-HER3 therapy -Patients with active other malignancies -History of any of the following diseases or comorbid medical conditions: interstitial lung disease, heart failure, myocardial infarction, cerebral infarction, active angina, arrhythmia requiring medication, coronary/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thrombosis, deep vein thrombosis, other clinically significant thromboembolic events, diverticulitis, or clinically significant pulmonary disease (e.g., lung infection, COPD, or asthma) -Patients with any severe or uncontrolled comorbid medical conditions in spite of medications -Has brain metastasis with clinical symptoms or requiring treatment -Has history of bleeding diathesis (e.g., hemoptysis) -Has history of serious drug hypersensitivity such as anaphylactoid reaction
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Advanced NSCLC has progressed on at least one prior chemotherapy
Intervention(s)		investigational material(s) Generic name etc : U3-1287 INN of investigational material : 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 -Determination of the recommended dose of U3-1287 for ubsequent clinical studies -NCI-CTC ver. 4.03
Secondary Outcome		-Preliminary assessment of anti-tumor activity of U3-1287 -Incidence of anti-U3-1287 antibody -Exploratory study on U3-1287-related biomarkers -RECIST ver. 1.1

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-111506
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Aug. 23, 2013	Detail	Changes
5	Aug. 23, 2013	Detail	Changes
4	June. 11, 2012	Detail	Changes
3	June. 11, 2012	Detail	Changes
2	May. 31, 2011	Detail	Changes
1	May. 31, 2011	Detail

List of change history