Status:
TERMINATED
A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
Lead Sponsor:
Eisai Inc.
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).
Detailed Description
Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS Phase II: To...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00282399
Start Date
October 1 2006
End Date
February 1 2009
Last Update
October 28 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
H Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
3
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461