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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00260065
First received: November 28, 2005
Last updated: May 13, 2013
Last verified: June 2010
History of Changes
  Purpose

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 Intervention Phase
Myelodysplastic Syndrome
 Drug: Decitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Number of Participants Who Achieved Overall Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Best Response and Overall Improvement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)


Enrollment: 99
Study Start Date: May 2005
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260065

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

Additional Information:
MGI Pharma's website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00260065     History of Changes
Other Study ID Numbers: DACO-020
Study First Received: November 28, 2005
Results First Received: April 13, 2009
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Myelodysplastic Syndrome
Decitabine
Dacogen
MGI Pharma

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Decitabine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013