NCT00669565

Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin to Treat Breast Cancer

A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, multicenter, single-arm, open-label safety and efficacy study of bavituximab in combination with carboplatin plus paclitaxel in patients with locally advanced or metastatic breast cancer.

Conditions

• Carcinoma Breast Stage IV

Interventions

Type	Name	Description
DRUG	Bavituximab	Receive weekly bavituximab at a dose of 3 mg/kg until disease progression, and carboplatin at a dose of AUC = 2 and paclitaxel 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle for up to 6 cycles.

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2008-04-30
• Last updated: 2011-03-24

Locations

9 sites across 1 country: India