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

Primary Purpose

Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Oral azacitidine
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Celgene Trial Site
  • Celgene Trial Site
  • Celgene Trial Site
  • Celgene Trial Site
  • Celgene Trial Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral azacitidine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PK- Maximum concentration in plasma (Cmax)
PK- Maximum concentration in plasma (Cmax)
PK- Time to maximum plasma concentration (Tmax)
PK- Time to maximum plasma concentration (Tmax)
PK-Elimination rate constant (Kel)
PK-Elimination rate constant (Kel)
PK-Terminal half-life (T1/2,z)
PK-Terminal half-life (T1/2,z)
PK-Area under the plasma concentration-time curve (AUC)
PK-Area under the plasma concentration-time curve (AUC)
PK-Apparent total body clearance (CL/F)
PK-Apparent total body clearance (CL/F)
PK-Apparent volume of distribution (Vz/f)
PK-Apparent volume of distribution (Vz/f)
Safety (type, frequency, severity, number of participants with adverse events)
Safety (type, frequency, severity, number of participants with adverse events)
Efficacy (Hematologic response and hematologic improvement)
Efficacy (Hematologic response and hematologic improvement)

Full Information

First Posted
April 3, 2012
Last Updated
November 7, 2019
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT01571648
Brief Title
A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Patients With Myelodysplastic Syndromes
Official Title
A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Subjects With Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2012 (Actual)
Primary Completion Date
January 1, 2013 (Actual)
Study Completion Date
January 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral azacitidine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oral azacitidine
Intervention Description
Patients will receive 300 mg dose of oral azacitidine administered once daily for the first 21 days of each 28-day treatment cycle.
Primary Outcome Measure Information:
Title
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
Description
Incidence of dose-limiting toxicity in accordance with Common Terminology Criteria for Adverse Events
Time Frame
1 month
Secondary Outcome Measure Information:
Title
PK- Maximum concentration in plasma (Cmax)
Description
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
Title
PK- Time to maximum plasma concentration (Tmax)
Description
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
Title
PK-Elimination rate constant (Kel)
Description
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
Title
PK-Terminal half-life (T1/2,z)
Description
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
Title
PK-Area under the plasma concentration-time curve (AUC)
Description
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
Title
PK-Apparent total body clearance (CL/F)
Description
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
Title
PK-Apparent volume of distribution (Vz/f)
Description
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
Title
Safety (type, frequency, severity, number of participants with adverse events)
Description
Safety (type, frequency, severity, number of participants with adverse events)
Time Frame
Up to 2 years
Title
Efficacy (Hematologic response and hematologic improvement)
Description
Efficacy (Hematologic response and hematologic improvement)
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masamitsu Harata
Organizational Affiliation
Celgene K.K.
Official's Role
Study Director
Facility Information:
Facility Name
Celgene Trial Site
City
Fukuoka
Country
Japan
Facility Name
Celgene Trial Site
City
Hiroshima
Country
Japan
Facility Name
Celgene Trial Site
City
Nagoya
Country
Japan
Facility Name
Celgene Trial Site
City
Osaka
Country
Japan
Facility Name
Celgene Trial Site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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