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NCT00670046 · ClinicalTrials.gov registry record · Phase 2
Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00670046: Clinical Trial Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00670046 is a Phase 2 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00670046, a Phase 2 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
RATIONALE: Valproic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether valproic acid is more effective than observation in treating patients with prostate cancer. PURPOSE: This randomized phase II trial is studying how well valproic acid works in treating patients with progressive, non-metastatic prostate cancer.
Primary Outcome
Number of participants exhibiting an increase in observed or predicted prostate-specific antigen (PSA) doubling time after initiation of the study. Blood was drawn monthly during study period (1 year), serum PSA was measured \& PSADT calculated. A doubling time of \> 10 month is defined as complete response (3. Secondary Outcome) and this criteria was based on the Pound et al JAMA 1999, Vol 281(No 17) pgs 1591-1697 paper. Any increase in PSADT is defined as partial response (4. Secondary Outcome
Interventions
- DRUG valproic acid
- OTHER standard of care follow-up
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2008-05 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
Why NCT00670046 stopped before completion
NCT00670046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which valproic acid is the first listed.
NCT00670046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00670046 about?
NCT00670046 is a clinical study titled "Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer". RATIONALE: Valproic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether valproic acid is more effective than observation in treating patients with prostate cancer. PURPOSE: This randomized phase II trial is studying how well va...
What is the current status of trial NCT00670046?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2008-05. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00670046?
The interventions under investigation include: valproic acid (DRUG), standard of care follow-up (OTHER).
Who is sponsoring clinical trial NCT00670046?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00670046's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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