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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). 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
Primary Outcome
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.
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 |
What the finished NCT00887458 record still lists
NCT00887458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Itraconazole 200 mg is the first listed.
NCT00887458 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00887458's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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