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| Sponsor: | AviGenics |
|---|---|
| Information provided by: | AviGenics |
| ClinicalTrials.gov Identifier: | NCT00497809 |
Purpose
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 |
|---|---|---|
|
Breast Cancer Neutropenia |
Drug: AVI-014 versus Filgrastim |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 189 |
| Study Start Date: | August 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
AVI-014 2.5mcg/kg
|
Drug: AVI-014 versus Filgrastim
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
|
|
Experimental: 2
AVI-014 5.0 mcg/kg
|
Drug: AVI-014 versus Filgrastim
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
|
|
Experimental: 3
AVI014 10.0 mcg/kg
|
Drug: AVI-014 versus Filgrastim
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
|
|
Active Comparator: 4
Filgrastim 5.0 mcg/kg
|
Drug: AVI-014 versus Filgrastim
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Pacific Cancer Medical Center | |
| Anaheim, California, United States, 92801 | |
| California Cancer Center | |
| Greenbrae, California, United States, 94904-2007 | |
| Ghassan Al-Jazayrly, MD, Inc. | |
| Los Angeles, California, United States, 90027 | |
| Desert Hematology Oncology Medical Group | |
| Rancho Mirage, California, United States, 92270 | |
| Brian LeBerthon, MD, A Medical Corporation | |
| West Covina, California, United States, 91790 | |
| Infosphere Clinical Research | |
| West Hills, California, United States, 91307 | |
| United States, Florida | |
| Physicians Research Alliance LLC. | |
| Debary, Florida, United States, 32713 | |
| United States, Illinois | |
| Southern Illinois Hematology/Oncology | |
| Centralia, Illinois, United States, 62801 | |
| United States, Ohio | |
| Gabrail Cancer Center | |
| Canton, Ohio, United States, 44781 | |
| Signal Point Clinical Research Center, LLC | |
| Middletown, Ohio, United States, 45042 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Ctr | |
| Oklaoma City, Oklahoma, United States, 73104 | |
| United States, South Carolina | |
| Cancer Care Institute of Carolina | |
| Aiken, South Carolina, United States, 29801 | |
| United States, Texas | |
| Cancer Specialists of South Texas | |
| Corpus Christi, Texas, United States, 78412 | |
| United States, Virginia | |
| Cancer Outreach Associates PC | |
| Abingdon, Virginia, United States, 24211 | |
| India | |
| Jawaharlal Nehru Cancer Hospital and Research Centre | |
| Idgah Hills, Bhopal, India, 462001 | |
| Apollo Specialty Hospital, Padma Complex | |
| 320 Mount Road, Chennai, India, 600 035 | |
| Amrita Institute of Medical Sciences | |
| Amrita Lane Elamakkara, Cochin, India, 682026 | |
| Dharamshila Hospital and research Centre | |
| Vasundhara Enclave, Delhi, India, 10096 | |
| Apollo Hospitals Educational and Research Foundation | |
| Jubilee hills, Hyderabad, India, 500033 | |
| Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda Road | |
| Bangalore, Karnataka, India, 560 029 | |
| Mohan Dai Oswal Cancer Treatment & Research Foundation | |
| G.T. Road, Sherpur Bye Pass, Ludhiana, India, 141009 | |
| Dayanand Medical College and Hospital | |
| Tagore Nagar, Civil Lines, Ludhiana, India, 141001 | |
| Meenakshi Mission Hospital and Research Centre | |
| Lake Area, Melur Road, Madurai,, India, 625107 | |
| Kasturba Medical College Hospital | |
| Attavar, Mangalore, India, 576104 | |
| Tata Memorial Hospital, | |
| Dr. E Borges Road, Parel, Mumbai, India, 400 012 | |
| Indraprastha Apollo Hospital | |
| Delhi Mathura road, Sarita vihar, New Delhi, India, 110076 | |
| Dharamshila Cancer Center, Dharamshila Marg | |
| Vasundhara Enclave, New Delhi, India, 110096 | |
| Regional Cancer Centre, IGIMS | |
| Sheikhpura, Patna, India, 800014 | |
| Ruby Hall Clinic | |
| 40 Sasoon Road, Pune, India, 411001 | |
| King George Hospital | |
| Vizag, Vishakhapattanam, India, 110076 | |
| IRCH, AIIMS, Ansari Nagar, | |
| New Delhi, India, 110029 | |
| 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 |
More Information
| Responsible Party: | Mark Hites, Director, Regulatory Affairs, AviGenics |
| ClinicalTrials.gov Identifier: | NCT00497809 History of Changes |
| Other Study ID Numbers: | AVI-014-P02 |
| Study First Received: | July 5, 2007 |
| Last Updated: | May 2, 2011 |
| 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 |
|
Breast Neoplasms Neutropenia Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Agranulocytosis Leukopenia |
Leukocyte Disorders Hematologic Diseases Lenograstim Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |