臨床研究等提出・公開システム

Date of registration	Sept. 02, 2010
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221225

Scientific Title	Phase 1 Study of U3-1287 -Assessment of the safety and pharmacokinetics of U3-1287 in patients with advanced solid tumors -
Public Title	Phase 1 Study of U3-1287

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		18
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 advanced solid tumors as listed below which are not curable with, or not eligible for standard treatment(s): Lung, breast, colorectal, prostate, ovarian, cervical, endometrial, gastric, pancreatic, bladder, head and neck, hepatocellular, esophageal, malignant melanoma, or sarcoma -ECOG performance status: 0-1
	Exclusion Criteria	-History of any of the following diseases within 6 months prior to study enrollment or comorbid medical conditions: 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, or clinically significant pulmonary disease (e.g., 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 solid tumors not curable with, or not eligible for standard treatment(s)
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 -To evaluate the safety profile according to CTCAE -To evaluate the pharmacokinetics according to the protocol
Secondary Outcome		-Incidence of anti-U3-1287 antibody -Determination of the recommended dose for subsequent clinical studies -Preliminary assessment of anti-tumor activity of U3-1287 -Exploratory study on U3-1287-related biomarkers -To evaluate anti-tumor activity in accordance with RECIST -To study potential U3-1287-related biomarkers according to the protocol

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-101262
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Nov. 16, 2012	Detail	Changes
7	Nov. 16, 2012	Detail	Changes
6	Oct. 31, 2011	Detail	Changes
5	Oct. 31, 2011	Detail	Changes
4	Jan. 27, 2011	Detail	Changes
3	Jan. 27, 2011	Detail	Changes
2	Sept. 02, 2010	Detail	Changes
1	Sept. 02, 2010	Detail

List of change history