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Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia

Primary Purpose

Breast Cancer, Neutropenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AVI-014 versus Filgrastim
Sponsored by
AviGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Neutropenia, Chemotherapy, High risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 participation.
  • 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.

Sites / Locations

  • Pacific Cancer Medical Center
  • California Cancer Center
  • Ghassan Al-Jazayrly, MD, Inc.
  • Desert Hematology Oncology Medical Group
  • Brian LeBerthon, MD, A Medical Corporation
  • Infosphere Clinical Research
  • Physicians Research Alliance LLC.
  • Southern Illinois Hematology/Oncology
  • Gabrail Cancer Center
  • Signal Point Clinical Research Center, LLC
  • University of Oklahoma Health Sciences Ctr
  • Cancer Care Institute of Carolina
  • Cancer Specialists of South Texas
  • Cancer Outreach Associates PC
  • Jawaharlal Nehru Cancer Hospital and Research Centre
  • Apollo Specialty Hospital, Padma Complex
  • Amrita Institute of Medical Sciences
  • Dharamshila Hospital and research Centre
  • Apollo Hospitals Educational and Research Foundation
  • Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda Road
  • Mohan Dai Oswal Cancer Treatment & Research Foundation
  • Dayanand Medical College and Hospital
  • Meenakshi Mission Hospital and Research Centre
  • Kasturba Medical College Hospital
  • Tata Memorial Hospital,
  • Indraprastha Apollo Hospital
  • Dharamshila Cancer Center, Dharamshila Marg
  • Regional Cancer Centre, IGIMS
  • Ruby Hall Clinic
  • King George Hospital
  • IRCH, AIIMS, Ansari Nagar,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

AVI-014 2.5mcg/kg

AVI-014 5.0 mcg/kg

AVI014 10.0 mcg/kg

Filgrastim 5.0 mcg/kg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

• Incidence of grade 4 neutropenia • Duration of neutropenia (defined as the number of days with ANC <0.5 x 109/L and <0.1 x 109/L)

Full Information

First Posted
July 5, 2007
Last Updated
May 2, 2011
Sponsor
AviGenics
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1. Study Identification

Unique Protocol Identification Number
NCT00497809
Brief Title
Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AviGenics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neutropenia
Keywords
Breast Cancer, Neutropenia, Chemotherapy, High risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AVI-014 2.5mcg/kg
Arm Title
2
Arm Type
Experimental
Arm Description
AVI-014 5.0 mcg/kg
Arm Title
3
Arm Type
Experimental
Arm Description
AVI014 10.0 mcg/kg
Arm Title
4
Arm Type
Active Comparator
Arm Description
Filgrastim 5.0 mcg/kg
Intervention Type
Drug
Intervention Name(s)
AVI-014 versus Filgrastim
Intervention Description
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
Primary Outcome Measure Information:
Title
The primary efficacy endpoint is duration of grade 4 neutropenia (DSN), defined as ANC <0.5 x 109/L during chemotherapy cycle 1.
Time Frame
First cycle of GCSF
Secondary Outcome Measure Information:
Title
• Incidence of grade 4 neutropenia • Duration of neutropenia (defined as the number of days with ANC <0.5 x 109/L and <0.1 x 109/L)
Time Frame
Cycle 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 participation. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Ozer, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert J. Grieve, M.B,Ch.B., FRCR
Organizational Affiliation
University Hospitals of Coventry and Warwickshire
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter Kraft, MD, MS, FACP
Organizational Affiliation
AviGenics
Official's Role
Study Chair
Facility Information:
Facility Name
Pacific Cancer Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
California Cancer Center
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904-2007
Country
United States
Facility Name
Ghassan Al-Jazayrly, MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Desert Hematology Oncology Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Brian LeBerthon, MD, A Medical Corporation
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Infosphere Clinical Research
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Physicians Research Alliance LLC.
City
Debary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Southern Illinois Hematology/Oncology
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44781
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
University of Oklahoma Health Sciences Ctr
City
Oklaoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cancer Care Institute of Carolina
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29801
Country
United States
Facility Name
Cancer Specialists of South Texas
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Cancer Outreach Associates PC
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Jawaharlal Nehru Cancer Hospital and Research Centre
City
Idgah Hills
State/Province
Bhopal
ZIP/Postal Code
462001
Country
India
Facility Name
Apollo Specialty Hospital, Padma Complex
City
320 Mount Road
State/Province
Chennai
ZIP/Postal Code
600 035
Country
India
Facility Name
Amrita Institute of Medical Sciences
City
Amrita Lane Elamakkara
State/Province
Cochin
ZIP/Postal Code
682026
Country
India
Facility Name
Dharamshila Hospital and research Centre
City
Vasundhara Enclave
State/Province
Delhi
ZIP/Postal Code
10096
Country
India
Facility Name
Apollo Hospitals Educational and Research Foundation
City
Jubilee hills
State/Province
Hyderabad
ZIP/Postal Code
500033
Country
India
Facility Name
Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda Road
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 029
Country
India
Facility Name
Mohan Dai Oswal Cancer Treatment & Research Foundation
City
G.T. Road, Sherpur Bye Pass
State/Province
Ludhiana
ZIP/Postal Code
141009
Country
India
Facility Name
Dayanand Medical College and Hospital
City
Tagore Nagar, Civil Lines
State/Province
Ludhiana
ZIP/Postal Code
141001
Country
India
Facility Name
Meenakshi Mission Hospital and Research Centre
City
Lake Area, Melur Road
State/Province
Madurai,
ZIP/Postal Code
625107
Country
India
Facility Name
Kasturba Medical College Hospital
City
Attavar
State/Province
Mangalore
ZIP/Postal Code
576104
Country
India
Facility Name
Tata Memorial Hospital,
City
Dr. E Borges Road, Parel
State/Province
Mumbai
ZIP/Postal Code
400 012
Country
India
Facility Name
Indraprastha Apollo Hospital
City
Delhi Mathura road, Sarita vihar
State/Province
New Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Dharamshila Cancer Center, Dharamshila Marg
City
Vasundhara Enclave
State/Province
New Delhi
ZIP/Postal Code
110096
Country
India
Facility Name
Regional Cancer Centre, IGIMS
City
Sheikhpura
State/Province
Patna
ZIP/Postal Code
800014
Country
India
Facility Name
Ruby Hall Clinic
City
40 Sasoon Road
State/Province
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
King George Hospital
City
Vizag
State/Province
Vishakhapattanam
ZIP/Postal Code
110076
Country
India
Facility Name
IRCH, AIIMS, Ansari Nagar,
City
New Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

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Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia

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