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

NCT00887458 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-10-16

Study results available
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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

Conditions

Interventions

DRUG

Itraconazole 200 mg

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

DRUG

Itraconazole 300mg

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

Sponsors & Collaborators

Principal Investigators

  • Michael A Carducci, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-05-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887458 on ClinicalTrials.gov