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ACTIVE NOT RECRUITING Phase 1

Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia

NCT00392353 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 135 participants
Start Date 2006-11-22
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00392353

The ClinicalTrials.gov registry entry for NCT00392353 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00392353 reports 7 study locations spanning 3 distinct geographic areas — top geographies include New York, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00392353?

The interventions under investigation include: Azacitidine (DRUG), Laboratory Biomarker Analysis (OTHER), Vorinostat (DRUG), Pharmacological Study (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00392353?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial