A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2021-02-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Niacinamide; Sorafenib

Criteria

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.