UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018388 |
|---|---|
| Receipt number | 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 10:30:03 |
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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 |
| Obstetrics 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
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
tsuba@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021292
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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