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Sponsored by: |
AviGenics |
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Information provided by: | AviGenics |
ClinicalTrials.gov Identifier: | NCT00497809 |
The overall purpose of this study is to assess the dose response, efficacy, and safety of three different dose levels of AVI 014 (granulocyte colony-stimulating factor [G-CSF]) in breast cancer patients at high (>20%) risk for chemotherapy-induced severe neutropenia.
Condition | Intervention | Phase |
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Breast Cancer Neutropenia |
Drug: AVI-014 versus Filgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Dose Finding, Prospective, Multi Center, Randomized, Parallel Group Study to Assess the Efficacy and Safety of Three Different Dose Levels of AVI 014 (G-CSF) Compared With a Standard Dose of Neupogen® in Breast Cancer Patients at High (>20%) Risk for Chemotherapy Induced Severe Neutropenia |
Estimated Enrollment: | 160 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | July 2009 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
AVI-014 2.5mcg/kg
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Drug: AVI-014 versus Filgrastim
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
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2: Experimental
AVI-014 5.0 mcg/kg
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Drug: AVI-014 versus Filgrastim
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
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3: Experimental
AVI014 10.0 mcg/kg
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Drug: AVI-014 versus Filgrastim
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
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4: Active Comparator
Filgrastim 5.0 mcg/kg
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Drug: AVI-014 versus Filgrastim
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
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Filgrastim is a recombinant human G-CSF (rhG-CSF) developed in the mid 1980s, and was approved by the United States (US) Food and Drug Administration (FDA) for use in chemotherapy induced neutropenia in 1991 under the trade name Neupogen®. Filgrastim was first approved in the EU in Germany in 2001 under the same trade name. Filgrastim is a non glycosylated protein, produced in E. coli bacteria transfected with rhG-CSF copy deoxyribonucleic acid (cDNA). Filgrastim differs from native human G CSF only in the addition of an N terminal methionine required for expression in a bacterial host. In 2002, a pegylated filgrastim with extended duration of action relative to the naked filgrastim was approved by the FDA and the EU Commission under the trade name Neulasta.
AviGenics has generated transgenic hens carrying rhG CSF cDNA, which express a glycosylated form of rhG-CSF protein in their egg white. The purified rhG-CSF is biologically active, as assessed by its in vitro binding and cell proliferation activities, and has been fully characterized by AviGenics. AviGenics intends to develop this product to treat chemotherapy-induced neutropenia.
The overall goal of this study is to assess dose response, efficacy, and safety of three different dose levels of AVI-014 (G-CSF) in breast cancer patients at high (>20%) risk for chemotherapy induced severe neutropenia.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Howard Ozer, MD | University of Oklahoma |
Principal Investigator: | Robert J. Grieve, M.B,Ch.B., FRCR | University Hospitals of Coventry and Warwickshire |
Study Chair: | Walter Kraft, MD, MS, FACP | AviGenics |
Responsible Party: | AviGenics ( Kristin Mauri, Director Clinical Operations ) |
Study ID Numbers: | AVI-014-P02 |
Study First Received: | July 5, 2007 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00497809 |
Health Authority: | United States: Food and Drug Administration; Romania: National Medicines Agency; India: Institutional Review Board; India: Ministry of Health |
Breast Cancer Neutropenia Chemotherapy High risk |
Signs and Symptoms Neutropenia Skin Diseases Hematologic Diseases Agranulocytosis |
Breast Neoplasms Leukocyte Disorders Leukopenia Granulocytopenia Breast Diseases |
Neoplasms Neoplasms by Site |