Bayer HealthCare 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 3 trial is evaluating regorafenib as adjuvant treatment of colorectal cancer following resection of liver metastases with curative intent.

 

“The COAST trial is another step forward in Bayer’s ongoing commitment to explore the full clinical potential of regorafenib for colorectal cancer patients across different stages of this disease,” said Dr. Jörg Möller, member of the Bayer HealthCare executive committee and head of global development. “Many patients with advanced colorectal cancer that has metastasized to the liver experience disease recurrence despite curative surgery and are in need of new treatment options.”

 

The COAST 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.

 

The study will be conducted in North America, Brazil, Europe, Asia, Israel and Australia.

 

Date: February 20, 2014

Source: Bayer HealthCare