To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
NCT ID: NCT01011283
Last Updated: 2014-10-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
26 participants
INTERVENTIONAL
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
decitabine
decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
2
azacitidine
azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
Interventions
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decitabine
decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
azacitidine
azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1 transfusion dependent, Intermediate-2, or High-risk \[defined by International Prognostic Scoring System (IPSS) score of ≥0.5\] and recognized French-American-British (FAB) classifications
2. Male or female, 18 years of age or older with signed informed consent
3. Adequate renal function
4. Demonstrated normal liver function
5. Female subjects of childbearing age must have negative pregnancy test within 1 week of study entry and agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.
6. Male subjects must agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.
Exclusion Criteria
1. Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering study (permitted if \> 2 weeks from study entry and if recovered from toxic effects of therapy)
2. Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing signs or symptoms of infection and without improvement despite appropriate treatment)
3. Pregnancy or current lactation
4. Significant concurrent disease, illness, or psychiatric disorder
5. Treatment with an investigational agent 30 days prior to the first dose of decitabine or azacitidine
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Stein
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States
Stanford University Cancer Center
Stanford, California, United States
Stockton Hematology Oncology
Stockton, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Pasco Pinellas Cancer Center
New Port Richey, Florida, United States
Gulf Coast Oncology
St. Petersburg, Florida, United States
University of Chicago
Chicago, Illinois, United States
Siouxland Haeatology - Oncology Associates
Sioux City, Iowa, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Sletten Cancer Institute
Great Falls, Montana, United States
Cornell Medical Center
New York, New York, United States
Carolinas Medical Center NorthEast NorthEast Oncology Associates
Concord, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Oncology and Hematology Care
Cincinnati, Ohio, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Gunderson Clinic Ltd.
La Crosse, Wisconsin, United States
Countries
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Other Identifiers
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E7373-A001-401
Identifier Type: -
Identifier Source: org_study_id
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