臨床研究等提出・公開システム

Date of registration	Sept. 14, 2015
Last modified on	Aug. 11, 2020
Trial ID	jRCT2080222965

Scientific Title	-
Public Title	-

Completion Date or Terminated date	Dec. 22, 2017
Actual Enrolled Number	719
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	July. 23, 2019
URL hyperlink(s) related to results and publications	https://doi.org/10.1007/s40259-019-00363-4

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	clinical-trials@pfizer.com

Contact for Public Queries	Name
	Contact Name for Public Queries	-
	Address	-
	Phone Number
	E-mail Address	clinical-trials@pfizer.com

Recruitment Status	completed

Date of First Enrolment		Feb. 10, 2016
Target Sample Size		710
Study Type		Interventional
Study Design	Study Design	-
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	-
	Exclusion Criteria	-
	Minimum Age	20age 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 : bevacizumab 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		efficacy -
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	Oct. 13, 2015

Secondary ID No.	NCT02364999
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-153017
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/South America/Europe/Oceania/Africa

History of Changes

No	Publication date
6	Aug. 11, 2020	(this page)	Changes
5	Feb. 19, 2019	Detail	Changes
4	Sept. 06, 2017	Detail	Changes
3	Nov. 18, 2016	Detail	Changes
2	Jan. 18, 2016	Detail	Changes
1	Sept. 14, 2015	Detail

List of change history