Breast CancerPhase 2NCT00497809
Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia
A Phase 2 study testing AVI-014 versus Filgrastim in people with Breast Cancer and Neutropenia, run by AviGenics at 31 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neutropenia
- What is being tested?
- AVI-014 versus Filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Aug 2007to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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[+]).
Show all 11Show fewer
- 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.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
India17 sites
Apollo Specialty Hospital, Padma Complex
320 Mount Road, Chennai, 600 035
Ruby Hall Clinic
40 Sasoon Road, Pune, 411001
Amrita Institute of Medical Sciences
Amrita Lane Elamakkara, Cochin, 682026
Kasturba Medical College Hospital
Attavar, Mangalore, 576104
Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda Road
Bangalore, Karnataka, 560 029
Indraprastha Apollo Hospital
Delhi Mathura Road, Sarita Vihar, New Delhi, 110076
Tata Memorial Hospital,
Dr. E Borges Road, Parel, Mumbai, 400 012
Mohan Dai Oswal Cancer Treatment & Research Foundation
G.T. Road, Sherpur Bye Pass, Ludhiana, 141009
Jawaharlal Nehru Cancer Hospital and Research Centre
Idgah Hills, Bhopal, 462001
Apollo Hospitals Educational and Research Foundation
Jubilee Hills, Hyderabad, 500033
Meenakshi Mission Hospital and Research Centre
Lake Area, Melur Road, Madurai,, 625107
IRCH, AIIMS, Ansari Nagar,
New Delhi, New Delhi, 110029
Regional Cancer Centre, IGIMS
Sheikhpura, Patna, 800014
Dayanand Medical College and Hospital
Tagore Nagar, Civil Lines, Ludhiana, 141001
Dharamshila Hospital and research Centre
Vasundhara Enclave, National Capital Territory of Delhi, 10096
Dharamshila Cancer Center, Dharamshila Marg
Vasundhara Enclave, New Delhi, 110096
King George Hospital
Vizag, Vishakhapattanam, 110076
United States14 sites
Cancer Outreach Associates PC
Abingdon, Virginia, 24211
Cancer Care Institute of Carolina
Aiken, South Carolina, 29801
Pacific Cancer Medical Center
Anaheim, California, 92801
Gabrail Cancer Center
Canton, Ohio, 44781
Southern Illinois Hematology/Oncology
Centralia, Illinois, 62801
Cancer Specialists of South Texas
Corpus Christi, Texas, 78412
Physicians Research Alliance LLC.
DeBary, Florida, 32713
California Cancer Center
Greenbrae, California, 94904-2007
Ghassan Al-Jazayrly, MD, Inc.
Los Angeles, California, 90027
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042
University of Oklahoma Health Sciences Ctr
Oklaoma City, Oklahoma, 73104
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270
Brian LeBerthon, MD, A Medical Corporation
West Covina, California, 91790
Infosphere Clinical Research
West Hills, California, 91307
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Neutropenia
- Being tested
- AVI-014 versus Filgrastim
- Keywords
- Breast Cancer, Neutropenia, Chemotherapy, High risk
- Medical subject headings
- Breast Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVI-014 versus FilgrastimDrug
3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AVI-014 2.5mcg/kg Receives: Drug: AVI-014 versus Filgrastim |
| 2 | Experimental | AVI-014 5.0 mcg/kg Receives: Drug: AVI-014 versus Filgrastim |
| 3 | Experimental | AVI014 10.0 mcg/kg Receives: Drug: AVI-014 versus Filgrastim |
| 4 | Active comparator | Filgrastim 5.0 mcg/kg Receives: Drug: AVI-014 versus Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is duration of grade 4 neutropenia (DSN), defined as ANC <0.5 x 109/L during chemotherapy cycle 1.
Measured: First cycle of GCSF
Secondary outcomes (1)
• 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)
Measured: Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- AviGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Howard Ozer, MD, Principal investigator, University of OklahomaRobert J. Grieve, M.B,Ch.B., FRCR, Principal investigator, University Hospitals of Coventry and WarwickshireWalter Kraft, MD, MS, FACP, Study chair, AviGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497809
- Sponsor's protocol ID
- AVI-014-P02
- Status last verified
- May 2011
- First submitted
- 5 Jul 2007
- Last updated
- 3 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00497809
- Acronym / sponsor ID
- AVI-014-P02
- Conditions
- Breast Cancer, Neutropenia
- Keywords
- Breast Cancer, Neutropenia, Chemotherapy, High risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- AviGenicsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AVI-014 versus FilgrastimAVI-014 2.5mcg/kg |
| 2 | Experimental | Drug: AVI-014 versus FilgrastimAVI-014 5.0 mcg/kg |
| 3 | Experimental | Drug: AVI-014 versus FilgrastimAVI014 10.0 mcg/kg |
| 4 | Active comparator | Drug: AVI-014 versus FilgrastimFilgrastim 5.0 mcg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVI-014 versus Filgrastim3 different dose arms of AVI-014 versus Filgrastim for up to 14 days daily | Drug | 1, 2, 3, 4 |
Primary outcome
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
1 secondary outcome
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Ozer, MD principal investigator
University of Oklahoma
Robert J. Grieve, M.B,Ch.B., FRCR principal investigator
University Hospitals of Coventry and Warwickshire
Walter Kraft, MD, MS, FACP study chair
AviGenics
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVI-014 versus Filgrastim in people with Breast Cancer and Neutropenia, run by AviGenics at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: First cycle of GCSF). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2011.