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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Bavituximab

• Registration Number: NCT00669591
• Lead Sponsor: Peregrine Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-28
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-04-30
• Primary Completion: 2010-06
• Study Completion: 2010-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bavituximab	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

Primary Outcome Measures

Name	Time	Method
Overall response rate (complete response + partial response) to a combination of bavituximab plus docetaxel in patients with metastatic breast cancer	Up to six (6) 28-day cycles of docetaxel plus weekly bavituximab until disease progression. After chemotherapy, weekly bavituximab is continued until disease progression. Approximate duration 1 year.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives include time to tumor progression, duration of response, overall survival, and safety.	Approximately 1 year

Trial Locations

Locations (4)

Ltd. Oncological Center; 🇬🇪 Batumi, Georgia

Ltd. Chemotherapy and Immunotherapy clinic Medulla 6, Jikia Str; 🇬🇪 Tbilisi, Georgia

Ltd. Tbilisi Oncological Dispensary; 🇬🇪 Tblisi, Georgia

JSC. National Cancer Centre; 🇬🇪 Lisi Lake, Tbilisi, Georgia