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

Peregrine Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Bavituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00669591

PPHM 0704

Details and patient eligibility

About

The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer

Enrollment: 46 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

1

Experimental group

Description:

Patients will receive up to six (6) 28-day cycles of docetaxel plus weekly bavituximab during the treatment phase. During the follow-up phase, patients will continue to receive weekly bavituximab until disease progression

Treatment:

Drug: Bavituximab