臨床研究等提出・公開システム

Date of registration	April. 10, 2018
Last modified on	Jan. 14, 2021
Trial ID	jRCT2080223866

Scientific Title	-
Public Title	-

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Novartis Pharma K.K.
	Address	-
	Phone Number	+81-120-003-293
	E-mail Address	-

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

Recruitment Status	completed

Date of First Enrolment		April. 27, 2018
Target Sample Size		92
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 : - 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		safety
Secondary Outcome		efficacy pharmacokinetics pharmacodynamics

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	Feb. 14, 2018

Secondary ID No.	NCT02740270
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-183922
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/Europe

History of Changes

No	Publication date
3	Jan. 14, 2021	(this page)	Changes
2	April. 11, 2019	Detail	Changes
1	April. 10, 2018	Detail

List of change history