drugset / Trial / NCT00941109

Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)

NCT00941109 ↗

Phase 1 Completed 12 enrolled Eisai Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine how the body absorbs decitabine when taken orally in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral dose.

Timeline

Start
2009-12
Primary completion
2011-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2 Oral
Subject Decitabine Small molecule 30 mg Oral
Subject Decitabine Small molecule 60 mg Oral
Subject Decitabine Small molecule 120 mg Oral
Subject Decitabine Small molecule 240 mg Oral