Bayer enrolls patients for Phase III trial of Stivarga (regorafenib) tablets in colorectal cancer

Bayer HealthCare today announced that the company has begun to enroll patients in the COAST trial studying Stivarga^® (regorafenib) tablets in colorectal cancer (CRC) patients with resected liver metastases. The randomized, double-blind, placebo-controlled Phase III trial is designed to determine the effects of Stivarga as adjuvant treatment following surgical removal of liver metastases.

"Patients with more advanced colorectal cancer often develop liver metastases – meaning the disease has spread to the liver," said Joseph Germino, Vice President of Medical Affairs, Oncology, Bayer HealthCare. "The COAST trial will investigate treatment with Stivarga in these patients following surgery to remove liver tumors and completion of chemotherapy."

Stivarga is approved by the U.S. Food and Drug Administration (FDA) to treat two different tumor types. In September 2012, Stivarga was first approved for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. In February 2013, the FDA also approved Stivarga to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.²

Source: Bayer HealthCare Pharmaceuticals Inc.