Status:
COMPLETED
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
Lead Sponsor:
Eisai Inc.
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Must sign an Institutional Review Board (IRB) -approved informed consent form.
- Must be 18 years of age or older.
- 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.
- If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
- If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.
Exclusion
- Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.
- Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
- Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
- Must not have an active viral or bacterial infection.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00260065
Start Date
May 1 2005
End Date
December 1 2008
Last Update
May 20 2013
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35235
2
Phoenix, Arizona, United States
3
Boca Raton, Florida, United States, 33486
4
Fort Myers, Florida, United States