solid tumors
Conditions
Interventions
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
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Ki-67 proliferative index after 2-4 weeks of oral itraconazole solution 400 mg PO daily. | — |
Secondary
| Measure | Time frame |
|---|---|
| (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. | — |
Countries
Japan
Contacts
Public ContactHiroshi Tsubamoto
Hyogo College of Medicine Obstetrics and Gynecology
Outcome results
None listed