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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aptose Biosciences Inc.

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