UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Evaluation of the Molecular Effects of Itraconazoleas an anti-cancer agent: A Window of Opportunity Study
Acronym	A window study of itraconazole
Scientific Title	Prospective Evaluation of the Molecular Effects of Itraconazoleas an anti-cancer agent: A Window of Opportunity Study
Scientific Title:Acronym	A window study of itraconazole
Region	Japan

Condition
Condition	solid tumors
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Dermatology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To determine the molecular effects of itraconazole as an anti-cancer agent
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Change in Ki-67 proliferative index after 2-4 weeks of oral itraconazole solution 400 mg PO daily.
Key secondary outcomes	(1) To identify effects of itraconazole on tumor angiogenesis, the Hedgehog pathway, and autophagy (2) Explore new target of itraconazole as an anti-cancer agent (3) To identify responders of itraconazole (4) To determine the clinical efficacy in cohort A.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Following tumor tissue biopsy and collection of peripheral blood, itraconazole solution 200 mg po BID daily will be taken for 2-4 weeks. Post-treatment biopsy in cohort A and planned surgery in cohort B will be conducted.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically or cytologically proven malignancy, ECOG 0-3 performance status, total bilirubin < 1.5 X institutional upper limit of normal, ability to understand and willingness to sign a written informed consent.
Key exclusion criteria	Uncontrolled bowel obstruction, history of allergic reactions attributed to itraconazole, current use of medications significantly affecting metabolism of itraconazole, pregnant or lactating female.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Tsubamoto
Organization	Hyogo College of Medicine
Division name	Obstetrics and Gynecology
Zip code	6638501
Address	Mukogawa 1-1, Nishinomiya, Hyogo
TEL	0798-45-6481
Email	tsuba@hyo-med.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Tsubamoto
Organization	Hyogo College of Medicine
Division name	Obstetrics and Gynecology
Zip code	6638501
Address	Mukogawa 1-1, Nishinomiya, Hyogo
TEL	0798-45-6481
Homepage URL
Email	tsuba@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo College of Medicine
Address	Mukogawa 1-1, Nishinomiya
Tel	0798-45-6481
Email	tsuba@hyo-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 06 Month 03 Day
Date of IRB	2015 Year 08 Month 01 Day
Anticipated trial start date	2015 Year 08 Month 10 Day
Last follow-up date	2026 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 22 Day
Last modified on	2021 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021292