Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040092
Status:
COMPLETED
Last Update Posted:
2008-01-07
First Post:
2002-06-19
Brief Title:
A Study to Test the Effectiveness of Virulizin Given in Combination With Standard Chemotherapy for Pancreatic Cancer
Sponsor:
Aptose Biosciences Inc
Organization:
Aptose Biosciences Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Virulizin is an immunotherapy drug preparation that is thought to stimulate the patients 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 cancerVirulizin efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None