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

Celgene

Status and phase: Completed; Phase 1

Conditions: Myelodysplastic Syndromes

Treatments: Drug: Oral azacitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01571648

AZA-MDS-005

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Oral azacitidine

Experimental group

Treatment:

Drug: Oral azacitidine