A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peregrine Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Bavituximab; Docetaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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