A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

Stopped early · Phase 1

Conditions studied: Myelodysplastic Syndrome

In brief

The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).

Key facts

Study ID

NCT00282399

Run by

Eisai Inc.

People needed

41

Starts

2006-10-01

Expected to finish

2009-02-01

Last updated by the study team

2015-10-28

Who can join

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

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).

You may not qualify if…

• Prior therapy with decitabine or azacytidine (Vidaza).
• Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
• Clinically significant anemia.
• Prior history of malignancy other than MDS.
• Any active infection.
• Radiotherapy within 14 days prior to study enrollment.

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• H Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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