198
Participants
Start Date
March 31, 2009
Primary Completion Date
January 31, 2011
Study Completion Date
February 29, 2012
Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease (PD)
Matching placebo + mFOLFOX6 (5-FU, levo-leucovorin, oxaliplatin)
Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m\^2 bolus and 2400 mg/m\^2 for 46-48 hrs; levo-leucovorin 200 mg/m\^2; 85 mg/m\^2 oxaliplatin) every 14 days until progressive disease
Bruxelles - Brussel
Budapest
Bruxelles - Brussel
Budapest
Budapest
Antwerp
Leuven
Liège
Debrecen
Kecskemét
Szeged
Székesfehérvár
Ghent
Győr
Torino
Genova
Cherkassy
Madrid
Málaga
Castelfranco Veneto
Udine
Pordenone
Verona
Santander
Sumy
Seville
Valencia
Valencia
Dnipropetrovsk
Dnipro
Kryvyi Rih
Kharkiv
Macerata
Wichita
Metairie
Dallas
Ivano-Frankivsk
Lviv
Donetsk
Mariupol
Uzhhorod
Palermo
Luhansk
Moscow
Moscow
Moscow
Yaroslavl
Ivanovo
Arkhangelsk
Syktyvkar
Saint Petersburg
Saint Petersburg
Saint Petersburg
Saint Petersburg
Saint Petersburg
Craiova-Dolj
Obninsk
Tula
Timișoara
Kursk
Krasnodar
Rostov-on-Don
Sochi
Pjatygorsk
Cluj-Napoca
Volgograd
Oradea
Astrakhan
Kazan'
Izhevsk
Baia Mare
Ulyanovsk
Samara
Chelyabinsk
Magnitogorsk
Alba Iulia
Vladimir
Nizhny Novgorod
Yekaterinburg
Novosibirsk
Irkutsk
Khabarovsk
Iași
Suceava
Brockton
Burlington
Bialystok
Elblag
Gdansk
Gdynia
Krakow
Krakow
Olsztyn
Warsaw
Warsaw
Wroclaw
Bucharest
Bucharest
Barcelona
Barcelona
L'Hospitalet de Llobregat
Manresa
Palma de Mallorca
Kiev
Bristol
Manchester
Liverpool
Northwood
Nottingham
Aberdeen
Belfast
Glasgow
Hull
London
Newcastle upon Tyne
Portsmouth