Bayer HealthCare has initiated patient enrolment in the COAST trial evaluating regorafenib (Stivarga) tablets in colorectal cancer (CRC) patients with resected liver metastases.
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) trial is evaluating regorafenib in patients with CRC after curative resection of liver metastases and completion of all planned chemotherapy.
The trial will investigate whether providing oral regorafenib in the adjuvant setting increases disease-free survival (DFS) and overall survival (OS).
Around 750 patients will be enrolled in the study and they will be randomised in a 1:1 ratio to receive either 160mg regorafenib or placebo.
According to the company, 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: "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 Phase III trial will be carried out in North America, Brazil, Europe, Asia, Israel and Australia.
Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumour growth and progression, angiogenesis, oncogenesis and the tumour microenvironment.
The preclinical studies have showed that Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumour neoangiogenesis.
Currently, the drug is approved in the US, Europe, Japan and in several other countries for the treatment of metastatic CRC.
Stivarga is also approved for the treatment of gastrointestinal stromal tumours (GIST), in the US, Japan and in several other countries.
In September 2013, Bayer submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the treatment of patients with GIST.
Image: Intermediate micrograph of a colorectal tubular adenoma without high grade dysplasia. Photo: courtesy of Nephron.