A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Subjects With Myelodysplastic Syndromes
Phase 1
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes
Both
Myelodysplastic Syndromes
Trial Information
A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Subjects With Myelodysplastic Syndromes
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
Outcome Description:
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
Outcome Time Frame:
1 month
Safety Issue:
Yes
Principal Investigator
Masamitsu Harata
Investigator Role:
Study Director
Investigator Affiliation:
Celgene K.K.
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
AZA-MDS-005
NCT ID:
NCT01571648
Start Date:
April 2012
Completion Date:
January 2013
Related Keywords:
- Myelodysplastic Syndromes
- Myelodysplastic Syndromes
- Preleukemia
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