A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Azacitidine; Decitabine

Criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

2. Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).

Exclusion Criteria:

1. Prior therapy with decitabine or azacytidine (Vidaza).

2. Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.

3. Clinically significant anemia.

4. Prior history of malignancy other than MDS.

5. Any active infection.

6. Radiotherapy within 14 days prior to study enrollment.