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NCT00384839 · ClinicalTrials.gov registry record · Phase 2

Vidaza to Restore Hormone Thx Prostate

A Phase 2 study, sponsored by US Oncology Research.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target

NCT00384839: Completed Phase 2 study, sponsored by US Oncology Research.

NCT00384839 is a Phase 2 study that has completed, run by US Oncology Research. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00384839, a Phase 2 study, has completed, sponsored by US Oncology Research.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target

Study Summary

The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this study, Pharmion Corporation, is the manufacturer of Vidaza.

Primary Outcome

To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state. This will be assessed by the proportion of patients who have a documented prostate specific antigen (PSA) doubling time \>3= months.

Interventions

  • DRUG azacitidine for injectable suspension

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2006-04
Est. Completion 2009-11
Phase Phase 2
US Oncology Research

27 total trials

What the finished NCT00384839 record still lists

NCT00384839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 1 intervention - of which azacitidine for injectable suspension is the first listed.

NCT00384839 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00384839 about?

NCT00384839 is a clinical study titled "Vidaza to Restore Hormone Thx Prostate". The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a...

What is the current status of trial NCT00384839?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2006-04. Estimated completion is 2009-11.

What interventions are being tested in trial NCT00384839?

The interventions under investigation include: azacitidine for injectable suspension (DRUG).

Who is sponsoring clinical trial NCT00384839?

This trial is sponsored by US Oncology Research, which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00384839's enrollment target sits among peer trials

36 1496th of 2000 higher than 477 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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Source: ClinicalTrials.gov NCT00384839, the US trial registry maintained by the National Library of Medicine. NCT00384839 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.