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

NCT01571648 | Completed Phase 1

• 1 other identifier: AZA-MDS-005
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Oral azacitidine

EXPERIMENTAL

Drug: Oral azacitidine

Interventions

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.

Oral azacitidine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (5)

Celgene Trial Site

Fukuoka, Japan

Location

Celgene Trial Site

Hiroshima, Japan

Location

Celgene Trial Site

Nagoya, Japan

Location

Celgene Trial Site

Osaka, Japan

Location

Celgene Trial Site

Tokyo, Japan

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Masamitsu Harata

  Celgene K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 5, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 12, 2019

Record last verified: 2019-11

Locations

JP (5)