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NCT00392353 · ClinicalTrials.gov registry record · Phase 1
Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
A Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 135
- Enrollment target
- 7
- Study locations
NCT00392353: Active Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).
NCT00392353 is a Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 135 participants, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (34% lower). The trial reports 7 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00392353, a Phase 1 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 135 participants
- Enrollment target
- 7
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of vorinostat and azacitidine and to see how well they work in treating patients with myelodysplastic syndromes or acute myeloid leukemia. Vorinostat may stop the growth of cancer or abnormal cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer or abnormal cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vorinostat together with azacitidine may kill more cancer or abnormal cells.
Primary Outcome
Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.
Conditions Studied
Interventions
- DRUG Azacitidine
- OTHER Laboratory Biomarker Analysis
- DRUG Vorinostat
- OTHER Pharmacological Study
Study Locations (7)
New York
- North Shore University Hospital - Manhasset
- Mount Sinai Hospital - New York
- NYP/Weill Cornell Medical Center - New York
- Montefiore Medical Center-Weiler Hospital - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2006-11-22 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT00392353 still lists
NCT00392353 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (34% lower).
The record links to 9 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Azacitidine is the first listed.
NCT00392353 lists 7 locations in 3 states (New York, Illinois, Maryland).
Frequently Asked Questions
What is clinical trial NCT00392353 about?
NCT00392353 is a clinical study titled "Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia". This phase I/II trial studies the side effects and best dose of vorinostat and azacitidine and to see how well they work in treating patients with myelodysplastic syndromes or acute myeloid leukemia. Vorinostat may stop the growth of cancer or abnormal cells by blocking some of the enzymes needed fo...
What is the current status of trial NCT00392353?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 135 participants. The study started on 2006-11-22. Estimated completion is 2026-12-31.
What conditions does trial NCT00392353 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Adult Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts.
What interventions are being tested in trial NCT00392353?
The interventions under investigation include: Azacitidine (DRUG), Laboratory Biomarker Analysis (OTHER), Vorinostat (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT00392353?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00392353 being conducted?
This trial has 7 study locations across Illinois, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00392353's enrollment target sits among peer trials
135 26th of 134 higher than 109 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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.
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