臨床研究等提出・公開システム

Date of registration	Oct. 10, 2019
Last modified on	Oct. 09, 2024
Trial ID	jRCT1080224910

Scientific Title	VANFLYTA Tablet Post-marketing Surveillance Study
Public Title	VANFLYTA Tablet Post-marketing Surveillance Study

Contact for Scientific Queries	Name	Contact for GPSP
	Contact Name for Scientific Queries	GPSP for Contact
	Address	3-5-1,Nihonbashi Honcho,Chuo-ku,Tokyo
	Phone Number	+81-3-6225-1059
	E-mail Address	contact_gpsp@daiichisankyo.co.jp

Contact for Public Queries	Name	Contact for GPSP
	Contact Name for Public Queries	GPSP for Contact
	Address	3-5-1,Nihonbashi Honcho,Chuo-ku,Tokyo
	Phone Number	+81-3-6225-1059
	E-mail Address	contact_gpsp@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		Oct. 10, 2019
Target Sample Size		210
Study Type		Observational
Study Design	Study Design	Observational surveillance (Post-marketing surveillance)
Study Design	Objective	other
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	All patients who start receiving VANFLYTA Tablet during the registration period.
	Exclusion Criteria	Patients with a previous history of hypersensitivity to the ingredients of VANFLYTA.
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Relapsed or refractory acute myeloid leukemia with FLT3-ITD mutation positive
Intervention(s)		investigational material(s) Generic name etc : Quizartinib Hydrochloride INN of investigational material : quizartinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : For adults, VANFLYTA should be administered at a starting dose of 26.5 mg as quizartinib once daily orally for 2 weeks, and then, the dose should be increased to 53 mg once daily. The dose may be reduced depending on the patient's condition. 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 Information about the adverse events that have occurred, by adverse reaction/infection category. Information about the safety specifications concerns that have occurred.
Secondary Outcome		efficacy Best antitumor response

Primary Sponsor	DAIICHI SANKYO CO., LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	3-5-1,Nihonbashi Honcho,Chuo-ku,Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-194995
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Oct. 09, 2024	(this page)	Changes
3	July. 22, 2024	Detail	Changes
2	Feb. 25, 2021	Detail	Changes
1	Oct. 16, 2019	Detail

List of change history