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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
207
administered intravenously
administered intravenously
administered intravenously
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
Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms
Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.
Time frame: Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).
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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
...and 32 more locations