Myelodysplastic Syndromes (MDS) Clinical Trial
Official title:
A Phase 1, Open-label, Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (AML).
The purpose of this study is to determine whether a tablet form of azacitidine that taken by mouth is safe. This Phase I study will also look at different doses and different treatment schedules in order to better understand the effects (positive and negative) of oral azacitidine on the body and on the disease MDS, AML and CMML.
Optional Extension Phase (OEP) to the AZA PH US 2007 CL 005 study which allows subjects who
continue to receive oral azacitidine and have stable disease or are demonstrating clinical
benefit as assessed by the Investigator, and have consented to participate, may enter the OEP
of this study (at their current doses) at the start of their next cycle.
Subjects who are entering the OEP should be discontinued from Part 1 or Part 2 protocol
prescribed therapy in the AZA PH US 2007 CL 005 study.
Subjects may continue to receive oral azacitidine in the OEP until they meet the criteria for
study discontinuation or oral azacitidine becomes commercially available. Subjects
discontinuing from the OEP will have an OEP discontinuation visit 28 days after the last dose
of study drug or at study withdrawal.
Primary Objective of OEP is to evaluate long term safety of oral azacitidine.
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