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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

Phase 2
18 Years
Not Enrolling
Breast Cancer, Neutropenia

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Trial Information

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.

Inclusion Criteria:

- Able to understand and voluntarily provide written informed consent before screening,
following an explanation of the nature and purpose of this study.

- Women, aged 18 years and older

- Histologically confirmed breast cancer, undergoing one of a variety of chemotherapy
regimens, or with other risk factors that could lead to a >20% risk of developing
severe neutropenia. Patients receiving chemotherapy regimens with high-risk for
severe neutropenia are eligible; eligibility of patients receiving intermediate-risk
chemotherapy regimens must be discussed with the Medical Monitor for the presence of
additional patient-specific risk factors.

- Must be receiving first-line adjuvant or neoadjuvant therapy for localized breast
cancer or first-line chemotherapy for metastatic breast cancer. It is recommended
that patients with human epidermal growth factor receptor 2 (HER2/neu)-positive
breast cancer should be receiving Herceptin® (trastuzumab), if approved and available
for this indication.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of grade 0 to 2

- Adequate renal (serum creatinine and blood urea nitrogen [BUN] <3 times the upper
limit of normal [ULN]) and hepatic (serum bilirubin, aspartate aminotransferase
[AST], and alanine aminotransferase [ALT] <3 times ULN) function.

- Able to adhere to the study visit schedule and other protocol requirements.

- Women who are not pregnant and do not plan to become pregnant during the study.
Women of childbearing potential must have a negative serum pregnancy test result
within seven days before the first dose of study drug and must be using adequate non
hormonal barrier contraception before entering the study and throughout the study.
Non childbearing potential is defined as post-menopausal for at least one year,
surgically sterile, or having had a hysterectomy before study start.

Exclusion Criteria:

- Pregnant or lactating women.

- History or clinical evidence of a serious medical illness, including renal, hepatic,
respiratory, cardiovascular, endocrine, neurologic, psychiatric, or hematologic
disease, which in the opinion of the investigator will interfere with study

- Metastatic brain or meningeal tumors.

- Ascites or pleural effusions.

- Any active infection requiring systemic antimicrobial therapy.

- Known to be positive for human immunodeficiency virus (HIV, anti-HIV+), hepatitis B
antigen (HBAg[+]), or hepatitis C antibody (HCVAb[+]).

- Known or suspected hypersensitivity to the study drug or its components, such as
avian products, including influenza vaccine, or to E. coli-derived proteins.

- Currently receiving radiation therapy for treatment of a malignant condition, or have
completed radiation therapy within 14 days before study entry. Radiation therapy for
oncologic emergency is allowed.

- Participated in another therapeutic clinical study (i.e., not an epidemiological
study or genomic screening study) during the past 30 days, or are likely to
simultaneously participate in another therapeutic clinical study.

- History of, or known current problems with, substance abuse, or any medical,
psychological, and/or social condition that may interfere with the patient's
participation in the study, or with evaluation of the study results.

- Any condition that could jeopardize the patient's safety and compliance, as judged by
the investigator.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint is duration of grade 4 neutropenia (DSN), defined as ANC <0.5 x 109/L during chemotherapy cycle 1.

Outcome Time Frame:

First cycle of GCSF

Safety Issue:


Principal Investigator

Howard Ozer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Oklahoma


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

July 2009

Related Keywords:

  • Breast Cancer
  • Neutropenia
  • Breast Cancer
  • Neutropenia
  • Chemotherapy
  • High risk
  • Breast Neoplasms
  • Neutropenia



California Cancer CenterFresno, California  93720
Gabrail Cancer CenterCanton, Ohio  44718
Cancer Specialists of South TexasCorpus Christi, Texas  78412
Cancer Care Institute of CarolinaAiken, South Carolina  29801
Pacific Cancer Medical CenterAnaheim, California  92801
Desert Hematology Oncology Medical GroupRancho Mirage, California  92270
Cancer Outreach Associates PCAbingdon, Virginia  24211
Southern Illinois Hematology/OncologyCentralia, Illinois  62801
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
Ghassan Al-Jazayrly, MD, Inc.Los Angeles, California  90027
Brian LeBerthon, MD, A Medical CorporationWest Covina, California  91790
Infosphere Clinical ResearchWest Hills, California  91307
Physicians Research Alliance LLC.Debary, Florida  32713
University of Oklahoma Health Sciences CtrOklaoma City, Oklahoma  73104