BERLIN, Germany I March 5, 2015 .
Bayer HealthCare today 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.
“We are disappointed that the extensive measures to increase recruitment did not have the desired outcome. We would like to thank the patients and the study investigators for their contributions and participation in this study,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “Importantly, this decision does not affect our commitment for Stivarga in the approved as well as potential additional indications. We will continue to evaluate regorafenib in a number of tumor types with significant unmet medical needs, including colorectal cancer.”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.
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