Conditions: Carcinoma, Hepatocellular
Keywords: Regorafenib BAY73-4506
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 573
Healthy volunteers: no

Brief summary:
The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.

Detailed description:

Arms:
arm 1: 160 mg orally (p.o.) every day (qd) for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off) plus BSC (Best Supportive Care) arm 2: 4 matching placebo tablets for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off) plus BSC

Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506) intervention 2: Placebo
Intervention descriptions: intervention 1: Regorafenib, 40 mg tablets intervention 2: Placebo tablets matching in appearance

Protocol document: