At a glance
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Clinical Study Protocol Phase 2, Randomized Study of CS-1008 in Combination With Sorafenib Compared to Sorafenib Alone as First-Line Systemic Therapy in Subjects With Advanced Hepatocellular Carcinoma
In Brief
A Phase 2 clinical trial evaluating CS-1008 2 mg/kg, Sorafenib, and 4 other interventions for Advanced Hepatocellular Carcinoma and 3 related conditions. Completed, enrolled 172 participants across 28 sites in 4 countries.
Detailed 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).
Study Details
Timeline
Interventions
On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg.
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.
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.
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.
On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated.
On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated.