To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.

This study has been terminated.
(The study was stopped due to insufficient enrollment.)
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01011283
First received: November 5, 2009
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: decitabine
Drug: azacitidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel-Group Study Comparing the Efficacy and Safety of DACOGEN (Decitabine) for Injection and VIDAZA (Azacitidine) for Injection In Subjects With Intermediate or High Risk Myelodysplastic Syndromes (MDS)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug. [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]

    Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.

    Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.

    Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.



Secondary Outcome Measures:
  • Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug. [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]

    Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.

    Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.

    Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.



Enrollment: 26
Study Start Date: November 2009
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: decitabine
decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
Other Name: Dacogen (decitabine)
Active Comparator: 2 Drug: azacitidine
azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
Other Name: Vidaza (azacitidine)

  Eligibility

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

Inclusion Criteria

Subjects who meet all of the following criteria may be included in the study:

  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

Subjects who meet any of the following criteria will be excluded from participation in the study:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011283

Locations
United States, Alabama
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States, 35205
United States, California
Stanford University Cancer Center
Stanford, California, United States, 94305
Stockton Hematology Oncology
Stockton, California, United States, 95204
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33619
Pasco Pinellas Cancer Center
New Port Richey, Florida, United States, 34652
Gulf Coast Oncology
St. Petersburg, Florida, United States, 33705
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
Siouxland Haeatology - Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Montana
Sletten Cancer Institute
Great Falls, Montana, United States, 59405
United States, New York
Cornell Medical Center
New York, New York, United States, 10021
United States, North Carolina
Carolinas Medical Center NorthEast NorthEast Oncology Associates
Concord, North Carolina, United States, 28025
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Oncology and Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States, 29403
United States, Tennessee
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Wisconsin
Gunderson Clinic Ltd.
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Karen Stein Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01011283     History of Changes
Other Study ID Numbers: E7373-A001-401
Study First Received: November 5, 2009
Results First Received: July 14, 2013
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
MDS

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

ClinicalTrials.gov processed this record on September 29, 2014