A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally
Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus
Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include
Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil.
Patients who have not received any prior chemotherapy will be randomized to receive
Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On
disease progression patients may be switched to 5-Fluorouracil and continue to receive
Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when
5-Fluorouracil is discontinued.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
United States: Food and Drug Administration