An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B as First Line Monotherapy in Patients With Unresectable Hepatocellular Cancer.
Inhibition of angiogenesis is considered a promising approach to the treatment of cancer.
Members of the VEGF family and the VEGFR-2 are important mediators of angiogenesis and are
likely important therapeutic targets in advanced HCC.
Angiogenesis appears integral to HCC development and pathogenesis. Angiogenesis inhibition
has been efficacious in both in vitro and in vivo HCC models and results of clinical studies
also suggest potential to inhibit disease growth.
Ramucirumab is a fully human MAb that specifically binds to the extracellular domain of
VEGFR-2 with high affinity. Phase 1 studies currently nearing completion have demonstrated
safety and tolerability at clinically relevant doses, with preliminary evidence of clinical
efficacy in a variety of human cancers.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival (PFS) in patients with unresectable hepatocellular cancer treated with the monoclonal antibody ramucirumab.
Every 6 weeks, with confirmatory assessment at least 4 weeks subsequent to initial objective response.
E-mail: ClinicalTrials@ ImClone.com
United States: Food and Drug Administration
|ImClone Investigational Site||Bakersfield, California 93309|
|ImClone Investigational Site||Decatur, Illinois 62526|
|ImClone Investigational Site||New Orleans, Louisiana 70121|
|ImClone Investigational Site||Philadelphia, Pennsylvania 19107|
|ImClone Investigational Site||Boston, Massachusetts 02135|