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

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571648
• Other study ID #: AZA-MDS-005
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2012
• Est. completion date: January 1, 2013

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 1, 2013
• Est. primary completion date: January 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Oral azacitidine
Patients will receive 300 mg dose of oral azacitidine administered once daily for the first 21 days of each 28-day treatment cycle.

Locations

Country	Name	City	State
Japan	Celgene Trial Site	Fukuoka
Japan	Celgene Trial Site	Hiroshima
Japan	Celgene Trial Site	Nagoya
Japan	Celgene Trial Site	Osaka
Japan	Celgene Trial Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events	Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events	1 month
Secondary	PK- Maximum concentration in plasma (Cmax)	PK- Maximum concentration in plasma (Cmax)	0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
Secondary	PK- Time to maximum plasma concentration (Tmax)	PK- Time to maximum plasma concentration (Tmax)	0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
Secondary	PK-Elimination rate constant (Kel)	PK-Elimination rate constant (Kel)	0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
Secondary	PK-Terminal half-life (T1/2,z)	PK-Terminal half-life (T1/2,z)	0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
Secondary	PK-Area under the plasma concentration-time curve (AUC)	PK-Area under the plasma concentration-time curve (AUC)	0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
Secondary	PK-Apparent total body clearance (CL/F)	PK-Apparent total body clearance (CL/F)	0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
Secondary	PK-Apparent volume of distribution (Vz/f)	PK-Apparent volume of distribution (Vz/f)	0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose
Secondary	Safety (type, frequency, severity, number of participants with adverse events)	Safety (type, frequency, severity, number of participants with adverse events)	Up to 2 years
Secondary	Efficacy (Hematologic response and hematologic improvement)	Efficacy (Hematologic response and hematologic improvement)	Up to 2 years