A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (REACH-2)

The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) (liver cancer) and elevated baseline alpha-fetoprotein.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Liver Cancer
What the trial is testing?
Ramucirumab
Could I receive a Placebo?
Yes
Enrollment Goal
399
Trial Dates
Jul 20, 2015 - Nov 19, 2021
How long will I be in the trial?
Your participation in this trial could last up to 3-5 months depending on on how you and your tumor respond.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have a confirmed diagnosis of liver cancer or a diagnosis of cirrhosis and a tumor with imaging characteristics of liver cancer

  • Participants in the United States, European Union, Taiwan and Hong Kong must have previously taken a therapy other than sorafenib for the treatment of liver cancer

  • Participants in China must have previously taken sorafenib for the treatment of liver cancer

  • Participant must be willing to provide blood for research

  • Female participant must not be pregnant or breastfeeding and must also use highly effective contraceptive method during study participation, if not surgically sterile or postmenopausal

  • Male participant must be surgically sterile or compliant with a highly effective contraceptive method

Participants Must Not:

  • Participant must not have undergone a prior liver transplant

  • Participant must not have uncontrolled hypertension, HIV, AIDS, active or uncontrolled clinically serious infection, ongoing or recent drug abuse, uncontrolled thrombotic or bleeding disorder or a bowel obstruction

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