Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia
Public ClinicalTrials.gov record NCT00497809. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00497809
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 189 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2007 (Type not available)
- Primary completion
- Jul 2008 (Actual)
- Completion
- Jul 2009 (Actual)
- Last update posted
- May 3, 2011
2007 – 2009
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pacific Cancer Medical Center | Anaheim | California | 92801 | — |
| California Cancer Center | Greenbrae | California | 94904-2007 | — |
| Ghassan Al-Jazayrly, MD, Inc. | Los Angeles | California | 90027 | — |
| 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 | — |
| Physicians Research Alliance LLC. | DeBary | Florida | 32713 | — |
| Southern Illinois Hematology/Oncology | Centralia | Illinois | 62801 | — |
| Gabrail Cancer Center | Canton | Ohio | 44781 | — |
| Signal Point Clinical Research Center, LLC | Middletown | Ohio | 45042 | — |
| University of Oklahoma Health Sciences Ctr | Oklaoma City | Oklahoma | 73104 | — |
| Cancer Care Institute of Carolina | Aiken | South Carolina | 29801 | — |
| Cancer Specialists of South Texas | Corpus Christi | Texas | 78412 | — |
| Cancer Outreach Associates PC | Abingdon | Virginia | 24211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00497809, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 3, 2011 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00497809 live on ClinicalTrials.gov.