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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 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.

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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.

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)

3,257 total trials

What the Registry Record Tells You About NCT00392353

The ClinicalTrials.gov registry entry for NCT00392353 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (34% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 3 distinct geographic areas - top geographies include 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.

Similar trials for Myelodysplastic Syndrome

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.