181
Participants
Start Date
April 7, 2011
Primary Completion Date
November 15, 2016
Study Completion Date
October 2, 2020
Regorafenib (BAY 73-4506)
Regorafenib, 160 mg, PO, Days 4-10 and Days 18-24 of 28 day cycle
FOLFIRI
FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.
Placebo
Placebo, 160 mg, PO, Days 4-10 and Days 18-24 of 28 day cycle
FOLFIRI
FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.
New York University Langone Medical Center, New York
North Shore Long Island Jewish Health System, Manhasset
University of Virginia, Charlottesville
Portsmouth Naval Medical Center, Portsmouth
The Moses Cone Regional Cancer Center, Greensboro
Southeast Medical Oncology Center, Goldsboro
University of North Carolina, Chapel Hill
Rex Cancer Center at Rex Hospital, Raleigh
Leo W. Jenkins Cancer Center at ECU Medical School, Greenville
Carolinas HealthCare System, Charlotte
First Health of the Carolinas, Moore Regional Hospital, Pinehurst
Seby B. Jones Cancer Center, Boone
Emory University, Atlanta
Georgia Cancer Specialists, Atlanta
Mount Sinai Medical Center-Miami, Miami
Moffitt Cancer Center, Tampa
University of Louisville James Brown Cancer Center, Louisville
Ohio State University Comprehensive Cancer Center, Columbus
University of Cincinnati, Cincinnati
Indiana University Simon Cancer Center, Indianapolis
Rocky Mountain Cancer Centers, Denver
Multicare Regional Cancer Center, Tacoma
Wake Forest University Comprehensive Cancer Center, Winston-Salem
Ireland Cooperative Clinical Research Group, Dublin
Collaborators (1)
Bayer
INDUSTRY
UNC Lineberger Comprehensive Cancer Center
OTHER