"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival time
12 month
Yes
Ask Aabenhus, MSc. (Pharm)
Study Director
Pharmexa A/S
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
PX115.1.1-302
NCT00358566
June 2006
August 2008
Name | Location |
---|---|
Southwest Regional Cancer Center | Austin, Texas 78705 |
University of South Alabama Mitchell Cancer Institute | Mobile, Alabama 36604 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Genesis Cancer Center | Hot Springs, Arkansas 71913 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Oncology Hematology Associates of Central Illinois, PC | Peoria, Illinois 61602 |
The Center for Hematology-Oncology | Boca Raton, Florida 33486 |
Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage, California 92270 |
Billings Clinic | Billings, Montana 59107-7000 |
Scripps Clinic Torrey Pines | La Jolla, California 92037 |
Tampa General Hospital Usf Digestive Disorders Centre | Tampa, Florida 33606 |
Portneuf Cancer Center | Pocatello, Idaho 83204 |
Hematology Oncology Specialists, Covington | Covington, Louisiana 70433 |
Berskhire Hematology Oncology PC | Pittsfield, Massachusetts 01201 |
Carolinas Hematology Oncology Associates | Charlotte, North Carolina 28203 |
Toledo Community Hospital Oncology Program | Toledo, Ohio 43617 |
Mary Crowley Medical Research Center, Worth St. | Dallas, Texas 75249 |
Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas | Dallas, Texas 75231 |
Oncology Consultants, PA | Houston, Texas 77024 |