The 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 evaluating regorafenib in patients with CRC after curative resection of liver metastases and completion of all planned chemotherapy.
The Phase III trial will investigate whether providing oral regorafenib in the adjuvant setting increases disease-free survival (DFS) and overall survival (OS).
About 750 patients will be enrolled in the trial and they will be randomized in a 1:1 ratio to receive either 160 mg regorafenib or placebo.
The company said that safety and tolerability of the treatment groups will be continuously monitored.
Bayer HealthCare member of the Executive Committee and head of Global Development Jörg Möller said the COAST trial is another step forward in the company’s ongoing commitment to explore the full clinical potential of regorafenib for colorectal cancer patients across different stages of this disease.
"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," Möller said.
The trial will be carried out in North America, Brazil, Europe, Asia, Israel and Australia.
Currently, Stivarga is approved in the US, Europe, Japan and in several other countries for the treatment of metastatic CRC.
In the US, Japan and in several other countries the drug is also approved for the treatment of gastrointestinal stromal tumors (GIST).
Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.