NCT01246986

A Study of LY2157299 in Participants With Hepatocellular Carcinoma

Phase 2 Study of LY2157299 in Patients With Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the median time to progression in participants with hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination with sorafenib or ramucirumab.

Detailed description

The study consists of four Parts: Part A where HCC participants with an increased alpha-fetoprotein (AFP) level will be treated with either 160 milligrams (mg) LY2157299 or 300 mg LY2157299. Part B where HCC participants with a normal AFP level will be treated with 300 mg LY2157299, Part C where treatment-naïve HCC participants will be treated with 160 mg LY2157299 + sorafenib or 300 mg LY2157299 + sorafenib, and Part D where HCC participants will be treated with either 160 mg or 300 mg LY2157299 + ramucirumab. Participants who continue to receive benefit from treatment at the time that the study is considered completed, may enter the treatment extension period and continue to receive the study treatment. The end of the study is the date of last visit or last scheduled procedure for the last active subject in the study.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	LY2157299	Administered orally
DRUG	Sorafenib	Administered orally
DRUG	Ramucirumab	Administered IV

Timeline

• Start date: 2011-03-30
• Primary completion: 2019-06-06
• Completion: 2019-12-24
• First posted: 2010-11-24
• Last updated: 2021-01-12
• Results posted: 2020-08-07

Locations

40 sites across 7 countries: United States, Australia, France, Germany, Italy, New Zealand, Spain