臨床研究等提出・公開システム

Date of registration	Oct. 25, 2017
Last modified on	Feb. 15, 2022
Trial ID	jRCT2080223693

Scientific Title	-
Public Title	-

Completion Date or Terminated date	Dec. 22, 2021
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	No
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	+81-120-003-293
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries
	Address
	Phone Number	+81-120-003-293
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Feb. 08, 2018
Target Sample Size		154
Study Type		Interventional
Study Design	Study Design
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria
	Exclusion Criteria
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied
Intervention(s)		investigational material(s) Generic name etc : INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : control material(s) Generic name etc : INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material :
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety
Secondary Outcome		safety efficacy pharmacokinetics

Primary Sponsor
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	approved
Date of Approval by IRB	Dec. 13, 2017

Secondary ID No.	NCT02947165
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173749
Name of Other Registries

Countries / Regions of Recruitment	Japan/North America/Europe

History of Changes

No	Publication date
4	Feb. 15, 2022	(this page)	Changes
3	April. 05, 2021	Detail	Changes
2	Feb. 04, 2018	Detail	Changes
1	Oct. 25, 2017	Detail

List of change history