A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma

A Randomized Phase 2 Study of LY2157299 Versus LY2157299 - Sorafenib Combination Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY2157299 in participants with hepatocellular carcinoma.

Inclusion Criteria:

• Have histological evidence of a diagnosis of HCC not amenable to curative surgery.
• Have Child-Pugh Class A.
• Have the presence of measurable disease.
• Have adequate organ function.
• Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• If male or female with reproductive potential, must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
• If females with childbearing potential, must have had a negative serum pregnancy test 7 days prior to the first dose of study drug.
• Are able to swallow capsules or tablets.
• Have available diagnostic or biopsy tumor tissue.

Exclusion Criteria:

• Have received previous systemic treatment for advanced disease.
• Have known HCC with fibro-lamellar or mixed histology.
• Have presence of clinically relevant ascites.
• Have had a liver transplant.
• Have moderate or severe cardiac disease.
• Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C virus infection.
• Have experienced Grade 3 or 4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to enrollment requiring transfusion or endoscopic or operative intervention.
• Have esophageal or gastric varices that require immediate intervention or represent a high bleeding risk.
• Had major surgery within 4 weeks prior to the study randomization.