Prospective Evaluation of the Molecular Effects of Itraconazoleas an anti-cancer agent: A Window of Opportunity Study
Phase 2
Recruiting
- Conditions
- solid tumors
- Registration Number
- JPRN-UMIN000018388
- Lead Sponsor
- Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Ki-67 proliferative index after 2-4 weeks of oral itraconazole solution 400 mg PO daily.
- Secondary Outcome Measures
Name Time Method (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.