A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes

May 13, 2013 updated by: Eisai Inc.

A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes

The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
    • Arizona
      • Phoenix, Arizona, United States
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Fort Myers, Florida, United States
      • Jacksonville, Florida, United States
      • New Port Richey, Florida, United States, 34652
    • Georgia
      • Griffin, Georgia, United States, 30224
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
      • Maywood, Illinois, United States, 60153
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • Buffalo, New York, United States, 14263
    • Ohio
      • Canton, Ohio, United States, 44718
    • South Carolina
      • Charleston, South Carolina, United States, 29406
    • Tennessee
      • Memphis, Tennessee, United States, 38138
    • Texas
      • Houston, Texas, United States, 77030
      • Midland, Texas, United States, 79701
    • Washington
      • Seattle, Washington, United States, 98104
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must sign an Institutional Review Board (IRB) -approved informed consent form.
  2. Must be 18 years of age or older.
  3. Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.
  4. If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
  5. If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.

Exclusion Criteria:

  1. Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.
  2. Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
  3. Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
  4. Must not have an active viral or bacterial infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Decitabine
20mg/m^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.
Other Names:
  • Dacogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Achieved Overall Response
Time Frame: 1 year
Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Response and Overall Improvement
Time Frame: 1 year
Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: Eisai US Medical Services, Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 28, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

December 1, 2005

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DACO-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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