Advanced Hepatocellular Carcinoma Clinical Trial
Official title:
Phase 2 Open-label Multi-Center Study to Evaluate the Efficacy and Safety of AMG 386 and Sorafenib as First Line Therapy for Subjects With Advanced or Inoperable Hepatocellular Carcinoma
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.
The primary objective is to evaluate the efficacy of AMG 386 in combination with sorafenib as measured by the progression free survival (PFS) rate at 4 months in subjects with advanced or inoperable hepatocellular carcinoma (HCC). ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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