Bayer Begins Regorafenib Phase III Trial

Bayer said that Regorafenib is a potent oral multi-kinase inhibitor with a kinase inhibition profile targeting angiogenic, stromal and oncogenic receptor tyrosine kinases.

The Correct (Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial is an international, multicenter, randomized, double-blind, placebo-controlled study that will enroll approximately 690 patients with metastatic CRC who have progressed after standard therapies.

According to the study, patients will be randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Treatment cycles will consist of 160 mg of regorafenib (or matching placebo) once daily for three weeks/one week off plus BSC.

The primary endpoint of the trial is overall survival, and secondary endpoints include progression-free survival, objective tumor response rate and disease control rate. The safety and tolerability of the two treatment groups will also be compared, said the company.

Kemal Malik, member of the board of management of Bayer Schering Pharma AG and head of Global Development, said: “There are very few treatment options available to patients with colorectal cancer whose disease has progressed following treatment with existing therapies.

“The initiation of a Phase III clinical trial for regorafenib marks the starting point for a potential new treatment option for colorectal cancer patients, and is an important milestone for Bayer in our ongoing effort to meet the unmet needs of people affected by cancer.”