Clinical Trials

multi-kinase inhibitor. Stivarga® (regorafenib) is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression - angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3 it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.

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 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.

* On March 5, 2015, Bayer HealthCare announced that it is suspending enrolment into a Phase III trial with regorafenib (Stivarga®) in colorectal cancer patients with resected liver metastases due to insufficient patient recruitment. The randomized, double-blind, placebo-controlled Phase III trial is evaluating regorafenib as an adjuvant treatment of colorectal cancer following resection of liver metastases with curative intent. As a result of slow patient accrual, the study will be closed to further enrolment before the study endpoints can be assessed. Importantly, there were no new safety signals from the study. Bayer is informing Health Authorities and investigators on the planned enrolment suspension. The company is actively working with the Data Monitoring Committee, the Study Steering Committee and investigators with regard to the appropriate disposition of patients who have entered into the trial. A summary of the findings will be disclosed to the public as available.

* On February 20, 2014, 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.