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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)


Phase 4
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes

Thank you

Trial Information

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)

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR), defined as proportion of patients having complete response (CR) or marrow complete response (mCR).

Outcome Time Frame:

Six Months

Safety Issue:

No

Principal Investigator

Karen Stein

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7373-A001-401

NCT ID:

NCT01011283

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Myelodysplastic Syndromes
  • MDS
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Florida Cancer SpecialistsFort Myers, Florida  33901
Cornell Medical CenterNew York, New York  10021
Sarah Cannon Cancer CenterNashville, Tennessee  37203
University of ChicagoChicago, Illinois  60637
Gabrail Cancer CenterCanton, Ohio  44718
Pasco Pinellas Cancer CenterNew Port Richey, Florida  34652
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Birmingham Hematology and Oncology AssociatesBirmingham, Alabama  35235
Gulf Coast OncologySt. Petersburg, Florida  33705
Stanford University Cancer CenterStanford, California  94305
Stockton Hematology OncologyStockton, California  95204
Sletten Cancer InstituteGreat Falls, Montana  59405
Charleston Hematology Oncology AssociatesCharleston, South Carolina  29403
University of Pittsburgh School of MedicinePittsburgh, Pennsylvania  15232
Siouxland Haeatology - Oncology AssociatesSioux City, Iowa  51101
Carolinas Medical Center NorthEast NorthEast Oncology Associates100 Medical Park Drive Suite 110 Concord, North Carolina  28025
Oncology and Hematology CareCincinnati, Ohio  45242
Gunderson Clinic Ltd.La Crosse, Wisconsin  54601