A Phase 2 Randomized, Double-Blind, Multicenter Trial of Amplimexon® Plus Gemcitabine Versus Gemcitabine Plus Placebo in Patients With Metastatic Chemotherapy Naïve Pancreatic Adenocarcinoma (Stage IV)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall Survival for the Intent to Treat Population
To compare the overall survival duration of the two treatment arms. Overall survival is measured from the time of randomization until reported death. Subjects were censored at last time known alive if lost to follow-up. Alive patients were censored at the last survival follow-up. Follow-up was monthly after off study treatment.
up to 2 years
No
Evan Hersh, MD
Study Director
AmpliMed Corporation
United States: Food and Drug Administration
AMP-019
NCT00637247
April 2008
June 2010
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Swedish Cancer Institute | Seattle, Washington 98104 |
Hunterdon Regional Cancer Center | Flemington, New Jersey 08822 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Hematology Oncology Associates | Morristown, New Jersey 07962 |
Lahey Clinic | Burlington, Massachusetts 01805 |
University of New Mexico | Albuquerque, New Mexico 87131 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Hematology Oncology Associates | Albuquerque, New Mexico 87106 |
Pottstown Memorial Medical Center | Pottstown, Pennsylvania 19464 |
Peachtree Hematology And Oncology Consultants | Atlanta, Georgia 30309 |
Birmingham Hematology and Oncology- US Oncology | Birmingham, Alabama 35205 |
AZ Onc Associates D.B.A. Hematology Oncology- US Oncology | Tucson, Arizona 85704 |
Rocky Mountain Cancer Center- US Oncology | Denver, Colorado 80218 |
Ocala Oncology Center- US Oncology | Ocala, Florida 34471 |
Cancer Centers of Florida- US Oncology | Orlando, Florida 34761 |
Hematology Oncology Associates of Illinois- US Oncology | Chicago, Illinois 60611 |
Cancer Care & Hematolog Specialists of Chicagoland- US Oncology | Niles, Illinois 60714 |
Central Indiana Cancer Centers- US Oncology | Indianapolis, Indiana 46227 |
Hope Center- US Oncology | Terre Haute, Indiana 47802 |
University of Kentucky, Hematology/Oncology/BMT Clinical Research | Lexington, Kentucky 40536-0093 |
Kansas City Cancer Center, LLC- US Oncology | Kansas City, Missouri 64131 |
Comprehensive Cancer Centers of Nevada- US Oncology | Las Vegas, Nevada 89169 |
University of New Mexico Cancer Center South | Las Cruces, New Mexico 88011 |
New Mexico Cancer Care Associates- US Oncology | Santa Fe, New Mexico 87505 |
Cancer Center of North Carolina- US Oncology | Raleigh, North Carolina 27607 |
Medical Onc Assoc of Wyoming Valley, PC- US Oncology | Kingston, Pennsylvania 18704 |
Associates in Hematology-Oncology P.C. US Oncology | Upland, Pennsylvania 19013 |
Reading Hospital Regional Medical Center | West Reading, Pennsylvania 19611 |
Sanford Clinic | Sioux Falls, South Dakota 57104 |
Texas Oncology - Amarillo- US Oncology | Amarillo, Texas 79106 |
Mamie Mcfaddin Ward Cancer Center, Texas Oncology- US Oncology | Beaumont, Texas 77702 |
Texas Oncology P.A.- Bedford- US Oncology | Bedford, Texas 76022 |
Texas Cancer Center at Medical City- US Oncology | Dallas, Texas 75230 |
Texas Oncology P.A. - Dallas- US Oncology | Dallas, Texas 75231 |
Methodist Charlton Cancer Center - Texas Oncology- US Oncology | Dallas, Texas 75237 |
Texas Oncology - Odessa- US Oncology | Odessa, Texas 79761 |
Scott and White Hospital and Clinics | Temple, Texas 76508 |
Texas Oncology Cancer Care and Research Center- US Oncology | Waco, Texas 76712 |
Texoma Cancer Center- US Oncology | Wichita Falls, Texas 76310 |
Virginia Oncology Associates- US Oncology | Norfolk, Virginia 23502 |
Onc & Hematology Assoc. of Southern VA, Inc D.B.A. - US Oncology | Salem, Virginia 24153 |
Cancer Care Northwest- US Oncology | Spokane, Washington 99202 |
Northwest Cancer Specialists- US Oncology | Vancouver, Washington 98684 |