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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary efficacy endpoint is duration of grade 4 neutropenia (DSN), defined as ANC <0.5 x 109/L during chemotherapy cycle 1.
First cycle of GCSF
No
Howard Ozer, MD
Principal Investigator
University of Oklahoma
United States: Food and Drug Administration
AVI-014-P02
NCT00497809
August 2007
July 2009
Name | Location |
---|---|
California Cancer Center | Fresno, California 93720 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Cancer Specialists of South Texas | Corpus Christi, Texas 78412 |
Cancer Care Institute of Carolina | Aiken, South Carolina 29801 |
Pacific Cancer Medical Center | Anaheim, California 92801 |
Desert Hematology Oncology Medical Group | Rancho Mirage, California 92270 |
Cancer Outreach Associates PC | Abingdon, Virginia 24211 |
Southern Illinois Hematology/Oncology | Centralia, Illinois 62801 |
Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
Ghassan Al-Jazayrly, MD, Inc. | Los Angeles, California 90027 |
Brian LeBerthon, MD, A Medical Corporation | West Covina, California 91790 |
Infosphere Clinical Research | West Hills, California 91307 |
Physicians Research Alliance LLC. | Debary, Florida 32713 |
University of Oklahoma Health Sciences Ctr | Oklaoma City, Oklahoma 73104 |