Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497809
Status:
COMPLETED
Last Update Posted:
2011-05-03
First Post:
2007-07-05
Brief Title:
Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia
Sponsor:
AviGenics
Organization:
AviGenics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None