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Brief Title: Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
Official Title: A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma
Study ID: NCT02289898
Brief Summary: This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma. The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.
Detailed Description:
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Providence Saint Joseph Medical Center, Burbank, California, United States
City of Hope, Duarte, California, United States
Scripps Cancer Center, La Jolla, California, United States
University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States
Soulhern California Permanente Medical Group, San Marcos, California, United States
Kaiser Permanente Medical Center, Vallejo, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Lynn Cancer Institute, Boca Raton, Florida, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
University of Michigan, Ann Arbor, Michigan, United States
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
University of Rochester, Rochester, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Kaiser Permanente NW Oncology Research, Portland, Oregon, United States
Thomas Jefferson University, Sydney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
Baylor College of Medicine, Houston, Texas, United States
Joe Arrington Cancer Research Treatment Center, Lubbock, Texas, United States
Huntsman Cancer Institute at The University of Utah, Salt Lake City, Utah, United States
Prince of Wales Hospital, Randwick, New South Wales, Australia
Monash Medical Centre, Moorabbin, Bentleigh East, Victoria, Australia
Western Health (Sunshine Hospitals), St Albans, Victoria, Australia
St John of God Murdoch Hospital, Murdoch, Western Australia, Australia
St. John of God Subiaco Hospital, Subiaco, Western Australia, Australia
Hopital Erasme, Brussels, Brussels Capital, Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
London Regional Cancer Program, London, Ontario, Canada
Sunnybrook Health Sciences Centre, Odette Cancer Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
St Josephs Health Centre, Toronto, Ontario, Canada
Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain
Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO), Barcelona, , Spain
Hospital General Universitario Gregorio Marafi6n, Madrid, , Spain
Hospital Universitario de Fuenlabrada, Madrid, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Bristol Haematology & Oncology Centre, Bristol, , United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom