54
Participants
Start Date
February 28, 2011
Primary Completion Date
March 31, 2012
Study Completion Date
June 30, 2014
Regorafenib (Stivarga, BAY73-4506)
Subjects will receive regorafenib 160 mg od on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets. In case of administration as a single agent during the study, regorafenib will be administered 160 mg od for 3 weeks on/1 week off. Each cycle consists of 28 days.
Oxaliplatin
On day 1 and day 15 of each cycle, participants will receive 85 mg/m\^2 oxaliplatin as a 2 hour i.v. infusion.
Folinic acid
On day 1 and day 15 of each cycle, participants will receive folinic acid (either 400 mg/m\^2 D/L-folinic acid or 200 mg/m\^2 L-folinic acid) as a 2 hour i.v. infusion.
5-FU (mFOLFOX6)
Participants will receive a 400 mg/m\^2 5 FU i.v. bolus injection immediately followed by a 2400 mg/m\^2 5 FU 46 hour i.v. infusion.
Bruxelles - Brussel
Concord
Edegem
Leuven
Woodville South
Genoa
Oldenburg
Madrid
Santander
Herne
Ancona
Stuttgart
Napoli
Chicago
Dresden
Barcelona
Manchester
Glasgow
Lead Sponsor
Bayer
INDUSTRY