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Completed

NCT Number: NCT01571648

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

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

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celgene Trial Site, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Azacitidine

Drug

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

Primary outcomes

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

    Time frame: 1 month

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

Secondary outcomes

  1. 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

    PK- Maximum concentration in plasma (Cmax)

  2. 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

    PK- Time to maximum plasma concentration (Tmax)

  3. 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

    PK-Elimination rate constant (Kel)

  4. 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

    PK-Terminal half-life (T1/2,z)

  5. 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

    PK-Area under the plasma concentration-time curve (AUC)

  6. 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

    PK-Apparent total body clearance (CL/F)

  7. 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

    PK-Apparent volume of distribution (Vz/f)

  8. Safety (type, frequency, severity, number of participants with adverse events)

    Time frame: Up to 2 years

    Safety (type, frequency, severity, number of participants with adverse events)

  9. Efficacy (Hematologic response and hematologic improvement)

    Time frame: Up to 2 years

    Efficacy (Hematologic response and hematologic improvement)

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2012
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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