臨床研究等提出・公開システム

Scientific Title	Prospective Evaluation of the Molecular Effects of Itraconazole as an anti-cancer agent: A Window of Opportunity Study (Window trial)
Public Title	Window trial (Window trial)

Contact for Scientific Queries	Name	Tsubamoto Hiroshi
	Affiliation	Hyogo Medical University Hospital
	Address	Mukogawa 1-1, Nishinomiya, Hyogo
	Telephone	+81-798-45-6481
	E-mail	tsuba@hyo-med.ac.jp
Contact for Public Queries	Name	Tsubamoto Hiroshi
	Affiliation	Hyogo Medical University Hospital
	Address	Mukogawa 1-1, Nishinomiya, Hyogo
	Telephone	+81-798-45-6481
	E-mail	tsuba@hyo-med.ac.jp

Recruitment status	Suspended

Anticipated date of first enrollment		Aug. 10, 2015
Actual date of first enrollment		Sept. 24, 2015
Target sample size		200
Study Type		Interventional
Study Design	allocation	single arm study
	masking	double blind
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who have window period before standard treatment And who have no standard treatment
	Exclusion Criteria	Patients who have drugs which interferes CYP3A
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Solid tumor
Intervention(s)		Administration of itraconazole for 2~4 weeks
Health Condition(s) Keyword		Repurposing, window trial
Intervention(s) Keyword		drug repositioning
Health Condition(s) Code		D009369
Intervention(s) Code		D058492
Primary Outcome(s)		Ki-67 index, serological and/or radiological response
Secondary Outcome(s)		Symptom control ratio, Response rate Adverse events Biomarker using tissue and blood Identification of new target

Name of Certified Review Board	Kobe city hospital organization certified review board
Address	2-1-1, Minatojima-minamimachi Chuo-ku, Kobe-city, Hyogo
Telephone	+81-78-302-5176
E-Mail	c_crb@kcho.jp
Approval Status	Approval
Date of approval	Mar. 15, 2019

Secondary ID(s)	UMIN000018388
Issuing Authority	University Hospital Medical Information Network

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history