臨床研究等提出・公開システム

Date of registration	Nov. 30, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223031

Scientific Title	Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects with Advanced Solid Tumors
Public Title	Phase 1 study of DS-1123a

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	dsclinicaltrial@daiichisankyo.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		27
Study Type		Interventional
Study Design	Study Design	Multi-center, open label study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available. -ECOG Performance Status (PS) of 0 or 1
	Exclusion Criteria	- Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment: Cardiac failure (NYHA >= ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic events, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia) - Severe or uncontrolled concomitant disease. - Clinically active brain metastases defined as symptomatic or requiring treatment.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
Intervention(s)		investigational material(s) Generic name etc : DS-1123a INN of investigational material : Therapeutic category code : 42- Antineoplastic 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, tolerability, and pharmacokinetics - The safety of DS-1123a will be assessed by CTCAE. - The maximum tolerated dose of DS-1123a, and the recommended dose of DS-1123a for the following clinical studies will be estimated.
Secondary Outcome		- Incidence of anti-DS-1123a antibody - Exploratory assessment of DS-1123a-related biomarkers - Exploratory assessment of tumor response to DS-1123a - Tumor response will be assessed by 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-153085
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
15	Dec. 17, 2018	(this page)	Changes
14	Dec. 25, 2017	Detail	Changes
13	Dec. 25, 2017	Detail	Changes
12	Dec. 25, 2017	Detail	Changes
11	Dec. 25, 2017	Detail	Changes
10	Oct. 17, 2017	Detail	Changes
9	Oct. 17, 2017	Detail	Changes
8	April. 21, 2017	Detail	Changes
7	April. 21, 2017	Detail	Changes
6	April. 13, 2017	Detail	Changes
5	April. 13, 2017	Detail	Changes
4	Mar. 17, 2016	Detail	Changes
3	Mar. 17, 2016	Detail	Changes
2	Nov. 30, 2015	Detail	Changes
1	Nov. 30, 2015	Detail

List of change history