NCT01807156

Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about the effect of the investigational agent tivozanib on the control of the tumor growth in hepatocellular (liver) cancer. The investigators also plan to collect information on the likelihood to develop side effects while on this treatment. Tivozanib is an oral medication (pill) taken once a day. This medication is designed to stop the tumor from developing new blood vessels.

Detailed description

Angiogenesis is the formation of new blood vessels. Angiogenesis is driven by cytokines 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.

Conditions

• Hepatocellular Cancer

Interventions

Type	Name	Description
DRUG	Tivozanib	Oral medication given daily. No placebo.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-03-08
• Last updated: 2016-04-22
• Results posted: 2016-04-22

Locations

1 site across 1 country: United States