Overview

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

Status:
Completed

Trial end date:
2013-12-01

Target enrollment:

Participant gender:

Summary

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

Phase:

Phase 2

Details

Lead Sponsor:

Johns Hopkins University

Collaborator:

Memorial Sloan Kettering Cancer Center

Treatments:

Hydroxyitraconazole
Itraconazole