A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Patients With Myelodysplastic Syndromes

A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Subjects With Myelodysplastic Syndromes

The purpose of this study is to evaluate the tolerability of oral azacitidine in the treatment of patients with Myelodysplastic Syndromes (MDS).

Inclusion Criteria:

Patients must satisfy the following criteria to be enrolled in the study:

• Have a documented diagnosis of myelodysplastic syndromes (MDS) according to World Health Organization (WHO) 2008 classification
• Age ≥ 20 years;
• Written informed consent;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Resolution of any toxic effects of prior anti-cancer therapy; and
• Negative urine or serum pregnancy test on females of childbearing potential.

Exclusion Criteria:

The presence of any of the following will exclude a patient from enrollment:

• Treatment with chemotherapy, radiotherapy, or surgery within 4 weeks of study registration;
• Pregnant or breast-feeding females;
• Previous or concomitant malignancy other than MDS;
• Significant active cardiac disease within the previous 6 months;
• Uncontrolled systemic infection or
• Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C