A Randomized Phase II Clinical Trial of Two Dose-levels of Itraconazole in Patients With Metastatic Castration-resistant Prostate Cancer
Itraconazole is an oral, generic, and commercially available antifungal drug with a long
safety record when used at doses ranging from 200 to 600 mg daily.
Itraconazole has been shown in cellular and animal models to be a potent angiogenesis
inhibitor as well as a Hedgehog pathway antagonist; both pathways are considered important
in prostate cancer. Itraconazole has not previously been tested as an antineoplastic agent,
but given its well-established safety profile, the gap between further preclinical studies
and human clinical trials can be narrowed to accelerate development of this agent as a
putative anticancer drug. We hypothesize that itraconazole will prevent PSA progression in a
significant proportion of men with metastatic CRPC and that it will have an acceptable
safety profile at both doses. Itraconazole may ultimately delay the need for chemotherapy in
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the proportion of patients with metastatic CRPC who do not have prostate specific antigen (PSA) progression after 24 weeks of therapy with one of two dose-levels of itraconazole: 200 mg or 600 mg daily.
To determine the proportion of patients without new/progressive metastases at 24 weeks, as demonstrated on CT and/or bone scan.
Up to 24 weeks
Michael A Carducci, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Johns Hopkins Hospital||Baltimore, Maryland 21287|
|Karmanos Cancer Center||Detroit, Michigan 48201|