Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer
Angiogenesis is the formation of new blood vessels. Angiogenesis is driven by cyokines
including vascular endothelial growth factor. Tivozanib is an oral medication that inhibits
vascular endothelial growth factor preventing tumor from developing new blood vessels.
The purpose of this study is to evaluate the effects of tivozanib on hepatocellular (liver)
cancer. Participants in the study take tivozanib daily at a dose of 1 mg for 1month. if
doing well the dose would be increased to 1.5 mg per day. Patients are monitored for
response using CT or MRI scans every 2months. In addition, patients will have blood draws to
evaluate the effects of tivozanib on blood vessels.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with advanced HCC(Hepatocellular cancer) receiving tivozanib who are free the proportion of patients with advanced HCC receiving tivozanib who are free from progression
Evaluation of disease progression will be made using CT or MRI scan of the organ(s) with the target lesion(s).
Bassel El-Rayes, MD
Emory University Winship Cancer Institute
United States: Food and Drug Administration
|Emory University, Winship Cancer Institute||Atlanta, Georgia 30322|