Conditions: Colorectal Neoplasms
Keywords: Stage IV colorectal cancer / Liver Metastasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.

Detailed description:

Arms:
arm 1: 4 regorafenib tablets taken orally in the morning daily, followed by a low fat meal for 3 weeks on off treatment followed by 1 week off without treatment,Treatment 21 days. arm 2: 4 placebo tablets taken orally in the morning daily,followed by a low fat meal for 3 weeks on off treatment followed by 1 week off without treatment,Treatment 21 days.

Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506) intervention 2: Placebo
Intervention descriptions: intervention 1: Four tablets of 40mg taken orally daily in the morning, dose of 160 mg for 21 days of treatment followed by 7 days without treatment intervention 2: Four tablets taken in the morning orally daily for 21 days of treatment followed by 7 days without treatment

Protocol document: