drugset / Trial / NCT01264705

Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer

NCT01264705

Phase 1/2 Completed 47 enrolled University of Texas Southwestern Medical Center
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study will be activated at the UT Southwestern Medical Center, comprised of The Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to surgical resection or orthotopic liver transplantation or is metastatic in nature.

Timeline

Start
2011-01
Primary completion
2018-04
Completion
2018-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bavituximab Monoclonal antibody 0.3 mg/kg Intravenous
Subject Bavituximab Monoclonal antibody 1 mg/kg Intravenous
Subject Bavituximab Monoclonal antibody 3 mg/kg Intravenous
Background Sorafenib Small molecule 400 mg Oral