Conditions: Advanced Hepatocellular Carcinoma Liver Cancer Hepatic Cancer Liver Neoplasms
Keywords: Sorafenib CS-1008 Advanced Liver Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 172
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and efficacy of CS-1008 in combination with sorafenib to sorafenib alone for treating liver cancer. Approximately 160 participants will take part in this study at approximately 22 sites (4 in the US, 8 in Japan, and 10 in Asia).

Detailed description:

Arms:
arm 1: Combination of CS-1008 and sorafenib; CS-1008 (2 mg/kg per week) in combination with sorafenib (400 mg self-administered by mouth twice daily) over 4 weeks observation, and may continue treatment until progression. arm 2: Combination of CS-1008 and sorafenib; CS-1008 (4 mg/kg per week) in combination with sorafenib (400 mg self-administered by mouth twice daily) over 4 weeks observation, and may continue treatment until progression. arm 3: Combination of CS-1008 and sorafenib; CS-1008 (6 mg/kg per week) in combination with sorafenib (400 mg self-administered by mouth twice daily) over 4 weeks observation, and may continue treatment until progression. arm 4: Combination of CS-1008 and sorafenib. Treatment Group 1: CS-1008 (6 mg/kg \[or as determined\] loading, 2 mg/kg/week maintenance) + sorafenib twice daily (N=50) arm 5: Combination of CS-1008 and sorafenib. Treatment Group 2: CS-1008 (6 mg/kg \[or as determined\] loading, 6 mg/kg/week \[or maximum tolerated dose {MTD}\] maintenance) + sorafenib twice daily (N=50) arm 6: Sorafenib. Treatment Group 3: sorafenib twice daily (N=50)

Interventions: intervention 1: CS-1008 2 mg/kg intervention 2: Sorafenib intervention 3: CS-1008 6/2 mg/kg intervention 4: CS-1008 6/6 mg/kg intervention 5: CS-1008 4 mg/kg intervention 6: CS-1008 6 mg/kg
Intervention descriptions: intervention 1: On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated. intervention 6: On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated.

Protocol document: