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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00394082 |
Purpose
The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab.
The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: ABI-007 plus Bevacizumab Drug: Bevacizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Weekly Administration of ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer |
| Enrollment: | 50 |
| Study Start Date: | June 2006 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ABI-007 plus Bevacizumab |
Drug: ABI-007 plus Bevacizumab
125 mg/m^2,IV on days 1,8,15 of 28 day cycle
Drug: Bevacizumab
10mg/kg given every 2 weeks beginning Cycle 1, Day 1
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.
Contacts and Locations| United States, Florida | |
| Melbourne, Florida, United States, 32901 | |
| Ocoee, Florida, United States, 34761 | |
| United States, Illinois | |
| Niles, Illinois, United States, 60714 | |
| United States, Indiana | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Maryland | |
| Columbia, Maryland, United States, 21044 | |
| Westminister, Maryland, United States, 21157 | |
| United States, Missouri | |
| St. Joseph, Missouri, United States, 64507 | |
| United States, New York | |
| Rochester, New York, United States, 14623 | |
| United States, Texas | |
| Bedford, Texas, United States, 76022 | |
| Dallas, Texas, United States, 75246 | |
| El Paso, Texas, United States, 79915 | |
| Odessa, Texas, United States, 79761 | |
| San Antonio, Texas, United States, 78229 | |
| Tyler, Texas, United States, 75702 | |
| United States, Virginia | |
| Fairfax, Virginia, United States, 22031 | |
| Norfolk, Virginia, United States, 23502 | |
| Salem, Virginia, United States, 24153 | |
| United States, Washington | |
| Burien, Washington, United States, 98166 | |
| Edmonds, Washington, United States, 98026 | |
| Vancouver, Washington, United States, 98684 | |
More Information
| Responsible Party: | Jose Iglesias, Abraxis BioScience |
| ClinicalTrials.gov Identifier: | NCT00394082 History of Changes |
| Other Study ID Numbers: | CA043 |
| Study First Received: | October 30, 2006 |
| Last Updated: | April 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Metastatic breast cancer, Abraxane, Bevacizumab |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Bevacizumab Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |