Phase 3 Trial of Regorafenib for Metastatic Colorectal Cancer

Onyx and Bayer Healthcare announced results from its Phase 3 CORRECT trial evaluating regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies. In a pre-planned interim analysis, the trial met its primary endpoint of statistically significant improvement in overall survival. CORRECT is an international, multicenter, randomized, double-blind, placebo-controlled study that enrolled 760 patients with mCRC whose disease has progressed after approved standard therapies. Patients were randomized to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Treatment cycles consisted of 160mg of regorafenib (or matching placebo) once daily for three weeks on / one week off plus BSC. The primary endpoint of this trial was overall survival. Secondary endpoints included progression-free survival, objective tumor response rate and disease control rate.

Regorafenib is an investigational oral multi-kinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases (TK)(4) and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

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