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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
  Purpose

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


Condition Intervention Phase
Myelodysplastic Syndromes
 Drug: Oral azacitidine
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Subjects With Myelodysplastic

Resource links provided by NLM:

Drug Information available for: Azacitidine
U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 5
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral azacitidine 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571648

Locations
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, Japan
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Masayuki Omote Celgene K.K.
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01571648     History of Changes
Other Study ID Numbers: AZA-MDS-005
Study First Received: April 3, 2012
Last Updated: November 15, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013