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NCT00887458 · ClinicalTrials.gov registry record · Phase 2
A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT00887458: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT00887458 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 46 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00887458, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study 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
Interventions
- DRUG Itraconazole 200 mg
- DRUG Itraconazole 300mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2009-07 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00887458
The ClinicalTrials.gov registry entry for NCT00887458 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Itraconazole 200 mg is the first listed.
NCT00887458 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00887458 about?
NCT00887458 is a clinical study titled "A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy". 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...
What is the current status of trial NCT00887458?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2009-07. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00887458?
The interventions under investigation include: Itraconazole 200 mg (DRUG), Itraconazole 300mg (DRUG).
Who is sponsoring clinical trial NCT00887458?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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