A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
Study Details
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.
Protocol Summary
Progression free survival (PFS) rate at 4 months
Timeframe: 4 months
Incidence of adverse events and significant laboratory abnormalities
Timeframe: Adverse events at every visit, significant laboratory abnormalities at least every 4 weeks
Objective response rate, Disease control rate, Progression free survival, Overall survival, Time to progression
Timeframe: Radiologic imaging every 8 weeks
Pharmacokinetic parameters for AMG 386 when used in combination with Sorafenib
Timeframe: Weeks 1, 2, 5, 9, and every 16 weeks thereafter
Pharmacokinetic parameter for Sorafenib when used in combination with AMG 386
Timeframe: Weeks 2, 5, 9, and every 16 weeks thereafter
Incidence of the occurrence of anti-AMG 386 antibody formation
Timeframe: Weeks 1, 5, 9, and every 16 weeks thereafter
Baseline values of and changes from baseline in pharmacodynamic, immunologic, biochemical, transcriptional, pharmacogenetic and angiogenic markers
Timeframe: Weeks 1, 2, 5, and every 16 weeks thereafter