A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes

Completed · Phase 2

Conditions studied: Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT00260065

Run by

Eisai Inc.

People needed

99

Starts

2005-05-01

Expected to finish

2008-12-01

Last updated by the study team

2013-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Boca Raton, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Griffin, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Rochester, Minnesota, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — Canton, Ohio, United States
• Study site — Charleston, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Midland, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — La Crosse, Wisconsin, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.