132
Participants
Start Date
September 30, 2013
Primary Completion Date
March 31, 2016
Study Completion Date
March 31, 2016
OGX-427
Three separate administrations of OGX-427 will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive 600mg OGX-427 prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. OGX-427 will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Placebo
Three separate administrations of Placebo will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive placebo prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. Placebo will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
Virginia Cancer Institute, Richmond
South Carolina Oncology Associates, Columbia
Florida Hospital Cancer Insitute, Orlando
Florida Cancer Specialists-North, St. Petersburg
Florida Cancer Specialists-South, Fort Myers
Tennessee Oncology, PLLC, Nashville
Tennessee Oncology - Chattanooga, Chattanooga
Oncology Hematology Care, Inc., Cincinnati
Ingalls Cancer Research Center, Harvey
The Center for Cancer and Blood Disorders, Fort Worth
University of California-San Francisco, San Francisco
Collaborators (1)
Achieve Life Sciences
INDUSTRY
SCRI Development Innovations, LLC
OTHER