Pancreatic Cancer Clinical Trial
Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. It is presented in vials as a sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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