臨床研究等提出・公開システム

Date of registration	Sept. 03, 2019
Last modified on	Nov. 04, 2022
Trial ID	jRCT2080224853

Scientific Title	-
Public Title	-

Completion Date or Terminated date	Dec. 31, 2022
Actual Enrolled Number	28
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	Yes
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	JAPIC-1@servier.com

Contact for Public Queries	Name
	Contact Name for Public Queries	-
	Address
	Phone Number
	E-mail Address	JAPIC-1@servier.com

Recruitment Status	completed

Date of First Enrolment		Oct. 18, 2019
Target Sample Size		28
Study Type		Interventional
Study Design	Study Design	-
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	-
	Exclusion Criteria	-
	Minimum Age	1age old over
	Maximum Age	21age old under
	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 : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy -
Secondary Outcome		safety - efficacy -

Primary Sponsor	-
Secondary 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	June. 23, 2019

Secondary ID No.	NCT04067518
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194937
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	Nov. 04, 2022	(this page)	Changes
5	Mar. 15, 2021	Detail	Changes
4	July. 28, 2020	Detail	Changes
3	Nov. 14, 2019	Detail	Changes
2	Oct. 23, 2019	Detail	Changes
1	Sept. 04, 2019	Detail

List of change history