The trial will enroll a total of 220 patients at approximately 45 sites in approximately 20 states and will assess efficacy, safety and patient quality of life as endpoints. Patients will be randomly assigned to receive either Nexavar and gemcitabine, or placebo and gemcitabine (Gemzar).
ACORN will enroll research sites, provide contract and budgeting services, foster the accrual of patients at the site level, collect data and monitor its accuracy, and provide overall project management for the trial.