NCT00040092

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

Completed Phase 3 Last updated 4 January 2008

What this trial tests

Phase 3 trial testing Virulizin® in Pancreatic Cancer in 400 participants. Completed.

Timeline

1 July 2002

Primary endpoint
1 July 2005

Quick facts

Lead sponsor	Aptose Biosciences Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	400
Start date	1 July 2002
Primary completion	1 July 2005

Drugs / interventions tested

• Virulizin® — full drug profile →

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Aptose Biosciences Inc. — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. From bench to bedside a comprehensive review of pancreatic cancer immunotherapy.
   Kunk PR, Bauer TW, Slingluff CL, Rahma OE. · · 2016 · cited 86× · PMID 26981244 · DOI 10.1186/s40425-016-0119-z
2. Network Meta-Analysis of Efficacy and Safety of Chemotherapy and Target Therapy in the First-Line Setting of Advanced Pancreatic Cancer.
   Lin KI, Yang JL, Lin YC, Chou CY, et al · · 2019 · cited 4× · PMID 31703359 · DOI 10.3390/cancers11111746