drugset / Trial / NCT01335204

Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer

NCT01335204

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research. This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy. Patients must meet the study eligibility criteria and must be competent to give informed consent.

Timeline

Start
2011-06
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Bavituximab Monoclonal antibody 3 mg/kg Intravenous
Subject Cabazitaxel Other / unclassified 25 mg/m2 Intravenous

Indications