NCT00358566

GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer

"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Pharmexa A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

Detailed description

The trial is a Phase III, multinational, multicentre, controlled, randomised open-label trial. It will involve 520 advanced pancreatic cancer patients. Patients will be randomly assigned to receive Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease. The experimental treatment is given prior to the current standard treatment in 50% of the patients.

Conditions

• Advanced Unresectable Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	GV1001	0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.
DRUG	Gemcitabine (Chemotherapy)	Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-08-01
• Last updated: 2008-05-19

Locations

86 sites across 12 countries: United States, Australia, Belgium, Denmark, France, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden