Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) - Full Text View

Purpose

The primary purpose of this study is to determine the effectiveness and safety of azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).

Condition	Intervention	Phase
High-Risk Myelodysplastic Syndromes	Drug: Azacitidine	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 4, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes.

Resource links provided by NLM:

MedlinePlus related topics: Blood Disorders Bone Marrow Diseases Cancer Myelodysplastic Syndromes

Drug Information available for: Azacitidine

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Proportion of participants with a hematologic response (defined as Complete Response and Partial Response), and Hematologic Improvement based on International Working Group 2000 response criteria for Myelodysplastic Syndromes. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Proportion of participants with a hematologic response (defined as Complete Response and Partial Response), and Hematologic Improvement based on International Working Group 2000 response criteria for Myelodysplastic Syndromes.

Secondary Outcome Measures:

Number of red blood cell transfusions [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Number of platelet transfusions [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Number of infections requiring intravenous antibiotics [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Safety (type, frequency, severity, and relationship of adverse events to azacitidine) [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Steady-state plasma azacitidine concentrations [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	October 2010
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 As indicated in Intervention description	Drug: Azacitidine Subjects will receive azacitidine 75 mg/m2/day SC for 7 days every 28 days for up to 6 cycles, unless they are discontinued from the treatment. In addition, subjects may receive best supportive care as needed, including antibiotics and transfusions, per Investigator discretion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A diagnosis of RAEB or RAEB-T according to FAB classification for MDS and with an IPSS score of intermediate-2 or high risk or a diagnosis of myelodysplastic CMML per modified FAB criteria.
Taiwanese males and females ≥ 18 years of age
ECOG 0, 1, or 2;
Adequate hepatic and renal organ function

Exclusion Criteria:

Previous treatment with azacitidine or decitabine
Malignant disease diagnosed within prior 12 months
Uncorrected red cell folate deficiency or vitamin B12 deficiency
Diagnosis of metastatic disease
Malignant hepatic tumors
Known or suspected hypersensitivity to azacitidine or mannitol
Prior transplantation or cytotoxic therapy, including azacitidine and chemotherapy, administered to treat MDS
Treatment with erythropoietin or myeloid growth factors during the 21 days prior to Day 1 of Cycle 1 or androgenic hormones during the 14 days prior to Day 1 of Cycle 1;
Active HIV or viral hepatitis type B or C
Treatment with other investigational drugs within the previous 30 days prior to Day 1 of Cycle 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period;
Pregnant or lactating females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201811

Locations

Taiwan
Changhua Christian Hospital
Changhua, Taiwan, 500
Chiayi Chang Gung Memorial Hospital
Chiayi, Taiwan, 613
Buddhist Tzu Chi General Hospital-Hualien Tzu Chi Medical Center
Hualien, Taiwan, 970
Kaohsiung Medical Hospital University
Kaohsiung, Taiwan, 807
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Shuang-ho Hospital
New Taipei City, Taiwan, 23561
China Medical University Hospital
Taichung, Taiwan, 404
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 10002
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Tri-Service General Hospital
Taipei, Taiwan, 11490

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

C L Beach, PharmD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01201811 History of Changes
Other Study ID Numbers:	AZA-MDS-001
Study First Received:	September 13, 2010
Last Updated:	April 23, 2013
Health Authority:	Taiwan : Food and Drug Administration

Keywords provided by Celgene Corporation:

Myelodysplastic Syndromes
Taiwan
Azacitidine
Vidaza
Celgene
Pathologic Processes
Neoplasms
Bone Marrow Diseases

Hematologic Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Enzyme inhibitors

Additional relevant MeSH terms:

Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Antimetabolites

Azacitidine
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013