臨床研究等提出・公開システム

Date of registration	Feb. 29, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221724

Scientific Title	Phase I Clinical Trial of DS-7423 - Evaluation of Safety and Pharmacokinetics of DS-7423 in Japanese Patients With Advanced Solid Tumors -
Public Title	Phase I Clinical Trial of DS-7423

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/corporate/rd/measure/clinical/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		27
Study Type		Interventional
Study Design	Study Design	Open label phase I clinical trial
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Histologically or cytologically diagnosed advanced solid tumors which are not curable with, or not eligible for standard treatment(s) - ECOG performance status: 0-1
	Exclusion Criteria	- 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, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event, clinically significant pulmonary disease (eg severe COPD or asthma) - History of type I and II diabetes - Patient with a clinically active brain metastasis, or who need drugs to control adverse event - History of pneumonitis - Patients with any severe or uncontrolled intercurrent diseases
	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 : DS-7423 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 4mg (starting dose) of DS-7423 will be administered orally once daily. After evaluation of starting dose, the dose of DS-7423 guided by the modified continuous reassessment method will be administered orally once daily.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety (including evaluation of maximum tolerated dose and recommended phase2 dose) and Pharmacokinetics - To evaluate the safety profile according to CTCAE - To evaluate the pharmacokinetics according to the protocol
Secondary Outcome		- Preliminary anti-tumor effect - Pharmacodynamics - Preliminary biomarker study - To evaluate anti-tumor effect according to RECIST - To evaluate pharmacodynamics of DS-7423 according to the protocol - To study potential biomarker of DS-7423 activity 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-121766
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
11	Dec. 17, 2018	(this page)	Changes
10	Oct. 21, 2015	Detail	Changes
9	Oct. 21, 2015	Detail	Changes
8	Sept. 19, 2014	Detail	Changes
7	Sept. 19, 2014	Detail	Changes
6	April. 17, 2014	Detail	Changes
5	April. 17, 2014	Detail	Changes
4	Mar. 13, 2013	Detail	Changes
3	Mar. 13, 2013	Detail	Changes
2	Feb. 29, 2012	Detail	Changes
1	Feb. 29, 2012	Detail

List of change history