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Brief Title: A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
Official Title: Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.
Study ID: NCT00282399
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 evaluate hematological responses at the dose selected in the Phase I portion of the study. Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Bronx, New York, United States