A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib

What is the purpose of this trial?

This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of Ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison. A total of 544 patients will be randomized, with an expected 434 mortality events.  Upon registration and completion of screening procedures, eligible patients with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this  agent, will be randomized to receive either ramucirumab DP or placebo.

The treatment regimen will be continued until radiographic progression or symptomatic deterioration characterized as progression of disease, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the patient, or investigator decision. During the study, disease imaging will be conducted every 6 weeks (± 3 days) following the first dose of study therapy for the first 6 months, and every 9 weeks (± 3 days) thereafter. Following discontinuation of study therapy, all patients will be followed for survival at regularly scheduled intervals (every 2 months ± 7 days) for as long as the patient is alive, or until the end of the trial.

Participation Guidelines

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Sponsor:

Eli Lilly and Company
Imclone Systems, Inc

Dates:

November 2011

Last Updated:

Study HIC#:

1108008910

Clinicaltrials.gov ID: Yale9507671