Stivarga enters trial for treatment of Colorectal Cancer after resection of liver metastases - Bayer

Bayer HealthCare has announced that the company has begun to enroll patients in the COAST trial studying regorafenib (Stivarga) tablets in Colorectal Cancer (CRC) patients with resected liver metastases. The randomized, double-blind, placebo-controlled Phase III trial is evaluating regorafenib as adjuvant treatment of colorectal cancer following resection of liver metastases with curative intent.

The Phase III Trial Design- COAST (Patients with Stage IV COlorectal Cancer treated with Adjuvant Regorafenib Versus Placebo after Curative Treatment of Liver Metastases in A Randomized, Double-blind, Placebo-controlled Phase-III STudy) clinical trial is studying regorafenib in patients with colorectal cancer after curative resection of liver metastases and completion of all planned chemotherapy. The study will investigate whether providing oral regorafenib in the adjuvant setting increases disease-free survival (DFS) and overall survival (OS). The trial will enroll approximately 750 patients who will be randomized in a 1:1 ratio to receive either 160 mg regorafenib or placebo. Safety and tolerability of the treatment groups will be continuously monitored.