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NCT00080899 · ClinicalTrials.gov registry record · Phase 2
Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00080899: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00080899 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00080899, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
This phase II trial is studying how well fenretinide works in treating patients with biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy) prostate cancer. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die
Primary Outcome
PSA normalization (PSA-N) was recorded as the best PSA response when a PSA level was undetectable (\< 0.1 ng/ml), and was then subsequently confirmed by a second measurement ≥ 4 weeks later. PSA partial response (PSA-PR) was recorded if the PSA decreased by ≥ 50% from pre-treatment or baseline values and was confirmed by a second measurement made ≥ 4 weeks later. Response = PSA-N + PSA-PR.
Interventions
- OTHER laboratory biomarker analysis
- DRUG fenretinide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2004-06 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
What the finished NCT00080899 record still lists
NCT00080899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT00080899 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00080899 about?
NCT00080899 is a clinical study titled "Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer". This phase II trial is studying how well fenretinide works in treating patients with biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy) prostate cancer. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so th...
What is the current status of trial NCT00080899?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2004-06. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00080899?
The interventions under investigation include: laboratory biomarker analysis (OTHER), fenretinide (DRUG).
Who is sponsoring clinical trial NCT00080899?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00080899's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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