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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT01571648

First received: April 3, 2012

Last updated: November 15, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 3, 2012

Last Updated Date

November 15, 2012

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01571648 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PK- Maximum concentration in plasma (Cmax) [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose ] [ Designated as safety issue: No ]
PK- Maximum concentration in plasma (Cmax)
PK- Time to maximum plasma concentration (Tmax) [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose ] [ Designated as safety issue: No ]
PK- Time to maximum plasma concentration (Tmax)
PK-Elimination rate constant (Kel) [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose ] [ Designated as safety issue: No ]
PK-Elimination rate constant (Kel)
PK-Terminal half-life (T1/2,z) [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose ] [ Designated as safety issue: No ]
PK-Terminal half-life (T1/2,z)
PK-Area under the plasma concentration-time curve (AUC) [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose ] [ Designated as safety issue: No ]
PK-Area under the plasma concentration-time curve (AUC)
PK-Apparent total body clearance (CL/F) [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose ] [ Designated as safety issue: No ]
PK-Apparent total body clearance (CL/F)
PK-Apparent volume of distribution (Vz/f) [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 hours post-dose ] [ Designated as safety issue: No ]
PK-Apparent volume of distribution (Vz/f)
Safety (type, frequency, severity, number of participants with adverse events) [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
Safety (type, frequency, severity, number of participants with adverse events)
Efficacy (Hematologic response and hematologic improvement) [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
Efficacy (Hematologic response and hematologic improvement)

Original Secondary Outcome Measures ^ICMJE

PK- Maximum concentration in plasma (Cmax) [ Time Frame: Up to 24 days ] [ Designated as safety issue: No ]
PK- Maximum concentration in plasma (Cmax)
PK- Time to maximum plasma concentration (Tmax) [ Time Frame: Up to 24 days ] [ Designated as safety issue: No ]
PK- Time to maximum plasma concentration (Tmax)
PK-Elimination rate constant (Kel) [ Time Frame: Up to 24 days ] [ Designated as safety issue: No ]
PK-Elimination rate constant (Kel)
PK-Terminal half-life (T1/2,z) [ Time Frame: Up to 24 days ] [ Designated as safety issue: No ]
PK-Terminal half-life (T1/2,z)
PK-Area under the plasma concentration-time curve (AUC) [ Time Frame: Up to 24 days ] [ Designated as safety issue: No ]
PK-Area under the plasma concentration-time curve (AUC)
PK-Apparent total body clearance (CL/F) [ Time Frame: Up to 24 days ] [ Designated as safety issue: No ]
PK-Apparent total body clearance (CL/F)
PK-Apparent volume of distribution (Vz/f) [ Time Frame: Up to 24 days ] [ Designated as safety issue: No ]
PK-Apparent volume of distribution (Vz/f)
Safety (type, frequency, severity, number of participants with adverse events) [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
Safety (type, frequency, severity, number of participants with adverse events)
Efficacy (Hematologic response and hematologic improvement) [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
Efficacy (Hematologic response and hematologic improvement)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Myelodysplastic Syndromes

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Oral azacitidine

Intervention: Drug: Oral azacitidine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

March 2015

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01571648

Other Study ID Numbers ^ICMJE

AZA-MDS-005

Has Data Monitoring Committee

Responsible Party

Celgene Corporation

Study Sponsor ^ICMJE

Celgene Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Masayuki Omote

Celgene K.K.

Information Provided By

Celgene Corporation

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top