172
Participants
Start Date
July 9, 2010
Primary Completion Date
July 13, 2012
Study Completion Date
September 9, 2013
CS-1008 2 mg/kg
On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg.
Sorafenib
On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal.
CS-1008 6/2 mg/kg
A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 2 mg/kg/week maintenance dose on a once-a-week basis.
CS-1008 6/6 mg/kg
A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 6 mg/kg/week maintenance dose on a once-a-week basis.
CS-1008 4 mg/kg
On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated.
CS-1008 6 mg/kg
On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated.
Changhua Christian Hospital, Changhua
National Cheng-Kung University Hospital, Tainan City
Kaohslung Medical University Hospital, Kaohsiung City
The Mount Sinai Medical Center, New York
Georgetown-Lombardi Cancer Center, Washington D.C.
Chang Gung Medical Foundation-Linkuo, Taoyuan District
Vanderbilt-Ingram Cancer Center, Nashville
Chi-Mei Medical Center, Tainan City
Kenmar Research Group, Los Angeles
Kurume University Hospital, Kurume-shi
Hiroshima University, Hiroshima
Kanazawa University, Kanazawa
Yamaguchi University Hospital, Ube
Kaohiung Chang Gung Hospital, Kaohsiung City
Chang Gung Memorial Hospital, Chiayi City
National Taiwan University Hospital, Taipei
Kinki University Hospital, Osaka
Chiba University Hospital, Chiba
Okayama University Hospital, Okayama
Osaka Med Center Cancer and Cardiovascular Disease, Osaka
Musashino Red-Cross Hospital, Tokyo
Keimyung University Dongsan Hospital, Daegu
Seoul National University Hospital, Seoul
Severance Hospital, Seoul
Samsung Medical Center, Seoul
Korea University Anam Hospital, Seoul
Catholic Univ. of Korea, Seoul St. Mary's Hospital, Seoul
Asan Medical Center, Seoul
Lead Sponsor
Daiichi Sankyo
INDUSTRY