drugset / Trial / NCT00872014

A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer

NCT00872014

Phase 2 Completed 60 enrolled Amgen
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who have not received any prior systemic therapy except surgery or locoregional therapy. Disease status and disease progression will be assessed every 8 weeks. Subjects will remain on treatment until: progressive disease by RECIST criteria; clinical progression; death or loss to follow-up; or withdrawal of informed consent.

Timeline

Start
2009-08
Primary completion
2011-10
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Trebananib Peptide 10 mg/kg Intravenous
Subject Trebananib Peptide 15 mg/kg Intravenous
Background Sorafenib Small molecule 400 mg Oral