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A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome

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Trial Information

A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Who Achieved Overall Response

Outcome Description:

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)

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Eisai US Medical Services

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

DACO-020

NCT ID:

NCT00260065

Start Date:

May 2005

Completion Date:

December 2008

Related Keywords:

  • Myelodysplastic Syndrome
  • Myelodysplastic Syndrome
  • Decitabine
  • Dacogen
  • MGI Pharma
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Hackensack, New Jersey  07601
Milwaukee, Wisconsin  
Charleston, South Carolina