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Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 200 mg

Itraconazole 300mg

Michael A Carducci, MD

This research is being done to test an investigational drug, called itraconazole, in the treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of various fungal infections such as fingernail/toenail infections and other more serious fungal infections. The word "investigational" means that itraconazole is not approved for use in people with cancer. However, the FDA is allowing the use of itraconazole in this research study. Itraconazole has been shown to have activity against cancer (including prostate cancer) in the laboratory, but has not been tested against cancer in humans.

The purpose of this study is to find out:

* If itraconazole is safe when given at two different doses
* How itraconazole affects prostate specific antigen (PSA): a blood test that measures substances released by prostate cancer
* Whether itraconazole can delay further prostate cancer growth and spread
* How itraconazole affects other markers of 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. The investigators 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 these men.

A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy

A Randomized Phase II Clinical Trial of Two Dose-levels of Itraconazole in Patients With Metastatic Castration-resistant Prostate Cancer

To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. "PSA progression" is defined as a 25% increase in PSA over baseline \[or nadir (lowest)\] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later.

Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.

Memorial Sloan Kettering Cancer Center

Johns Hopkins University

Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Low Dose

Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

High Dose

Total

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Michael Carducci

Low Dose Itraconazole

High Dose Itraconazole

Based on how many participants were evaluable for the study primary endpoint

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.

One subject in the high dose arm was not evaluable on account of subject discontinuing study drug during cycle 1 due to clinical progression.

To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy	NCT00887458	Prostate Cancer	Itraconazole 20... Itraconazole 30...	18 Years -	Johns Hopkins University
A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy	NCT00887458	Prostate Cancer	Itraconazole 20... Itraconazole 30...	18 Years -	Johns Hopkins University

Spots Global Cancer Trial Database for itraconazole 300mg