A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00040092|
Recruitment Status : Completed
First Posted : June 20, 2002
Last Update Posted : January 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Virulizin®||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||July 2005|