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Clinical Trial Summary

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


Clinical Trial 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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00282399
Study type Interventional
Source Eisai Inc.
Contact
Status Terminated
Phase Phase 1
Start date October 2006
Completion date February 2009

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