A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
The purpose of this study is to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.|
- Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS.
- Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.
|Study Start Date:||October 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Phase I: The purpose of this study is 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 evaluate hematological responses at the dose selected in the Phase I portion of the study.
|United States, Arizona|
|University of Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, Florida|
|H Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|