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NCT00503984 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients
A Phase 1 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00503984: Clinical Trial Phase 1 study, sponsored by University of Miami.
NCT00503984 is a Phase 1 study that was terminated before completion, run by University of Miami. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00503984, a Phase 1 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.
Primary Outcome
Determination of a safe and potentially efficacious phase II dose of azacitidine in combination with docetaxel and prednisone that can be used for the treatment of hormone refractory metastatic prostate cancer.
Interventions
- DRUG Docetaxel
- DRUG Azacitidine
- DRUG Prednisone
- DRUG Pegfilgrastim
- GENETIC GADD45α methylation and expression analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2007-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
Why NCT00503984 stopped before completion
NCT00503984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT00503984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00503984 about?
NCT00503984 is a clinical study titled "A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients". Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes.
What is the current status of trial NCT00503984?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2007-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00503984?
The interventions under investigation include: Docetaxel (DRUG), Azacitidine (DRUG), Prednisone (DRUG), Pegfilgrastim (DRUG), GADD45α methylation and expression analysis (GENETIC).
Who is sponsoring clinical trial NCT00503984?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00503984's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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