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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00260065
Recruitment Status : Completed
First Posted : December 1, 2005
Results First Posted : September 4, 2009
Last Update Posted : May 20, 2013
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Decitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes
Study Start Date : May 2005
Primary Completion Date : June 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine
U.S. FDA Resources

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 Name: Dacogen

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Best Response and Overall Improvement [ Time Frame: 1 year ]
    Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260065

  Show 21 Study Locations
Sponsors and Collaborators
Eisai Inc.
Study Director: Eisai US Medical Services Eisai Inc.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00260065     History of Changes
Other Study ID Numbers: DACO-020
First Posted: December 1, 2005    Key Record Dates
Results First Posted: September 4, 2009
Last Update Posted: May 20, 2013
Last Verified: June 2010

Keywords provided by Eisai Inc.:
Myelodysplastic Syndrome
MGI Pharma

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors