Status:
COMPLETED
A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer
Lead Sponsor:
Peregrine Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer
Eligibility Criteria
Inclusion
- Adult females over age 18 with life expectancy of at least 3 months
- Histologically or cytologically confirmed locally advanced or metastatic breast cancer
- One and only one prior chemotherapy regimen (no prior docetaxel)
- Measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral CT)
- Adequate hematologic, renal, and hepatic function;
Exclusion
- Known history of bleeding diathesis or coagulopathy
- Any current evidence of clinically significant bleeding
- Any history of thromboembolic events
- Concurrent hormone therapy
- Prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00669591
Start Date
January 1 2008
End Date
August 1 2010
Last Update
April 21 2017
Active Locations (4)
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1
JSC. National Cancer Centre
Lisi Lake, K'alak'i T'bilisi, Georgia, 0177
2
Ltd. Oncological Center
Batumi, Georgia, 6000
3
Ltd. Tbilisi Oncological Dispensary
Tbilisi, Georgia, 0171
4
Ltd. Chemotherapy and Immunotherapy clinic Medulla 6, Jikia Str
Tbilisi, Georgia, 0176