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NCT00496444 · ClinicalTrials.gov registry record · Phase 1
Azacytidine and Valproic Acid in Patients With Advanced Cancers
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT00496444: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00496444 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00496444, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
Primary Objective: 1\. To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in patients with advanced cancer. Secondary Objectives: 1. To perform a preliminary assessment of the histone acetylation and DNA methylation effects of this combination on peripheral blood mononuclear cells (PBMC). 2. To assess the clinical anti-tumor activity (objective response including complete and partial responses) of this combination in patients with advanced cancer, in a descriptive fashion.
Interventions
- DRUG Azacitidine
- DRUG Valproic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
What the finished NCT00496444 record still lists
NCT00496444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT00496444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00496444 about?
NCT00496444 is a clinical study titled "Azacytidine and Valproic Acid in Patients With Advanced Cancers". Primary Objective: 1\. To evaluate side effects and maximum tolerated dose of azacitidine and valproic acid in patients with advanced cancer. Secondary Objectives: 1. To perform a preliminary assessment of the histone acetylation and DNA methylation effects of this combination on peripheral blood...
What is the current status of trial NCT00496444?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2005-05. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00496444?
The interventions under investigation include: Azacitidine (DRUG), Valproic Acid (DRUG).
Who is sponsoring clinical trial NCT00496444?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00496444's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 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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