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

Status
Active
Cancer Type
Liver Cancer
Trial Phase
Phase III
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01140347
Protocol IDs
13895 (primary)
2010-019318-26
CP12-0919
I4T-IE-JVBF
Study Sponsor
ImClone Systems, Incorporated

Summary

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.

Approximately 544 patients will be randomized and will be at least 18 years of age with HCC. Patients must have received sorafenib as first-line systemic treatment for HCC, and must have discontinued sorafenib prior to entering the study.

Hypothesis: This sample size will allow differentiation of the expected increase in median OS, from 6 months in the placebo arm to 8 months with the addition of ramucirumab).

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 or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the patient, or investigator decision.