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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Azacitidine

Criteria

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