A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer

Aptose Biosciences

Status and phase

Completed

Phase 3

Conditions

Pancreatic Cancer

Treatments

Drug: Virulizin®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00040092

LOR/VIR/P03/002

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV)
No previous systemic chemotherapy(unless given as a radiosensitizer).
ECOG Performance Status 0-2
Life expectancy equal to or greater than 12 weeks
Adequate laboratory and organ functions
Stabilizable pain (stable analgesic intake)
No radiotherapy during 4 weeks prior to trial entry
No evidence of ascites, pleural effusion or third space fluid accumulation
Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy