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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018388
Receipt No. R000021292
Scientific Title Prospective Evaluation of the Molecular Effects of Itraconazoleas an anti-cancer agent: A Window of Opportunity Study
Date of disclosure of the study information 2015/08/10
Last modified on 2021/01/24

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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/ctr_e/ctr_view.cgi?recptno=R000021292

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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