Bayer HealthCare Initiates CRC Trial with Stivarga

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Bayer HealthCare announced that it has begun enrolling patients into the Phase 3 COAST trial studying Stivarga (regorafenib) tablets, a kinase inhibitor in colorectal cancer (CRC) patients with resected liver metastases.

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 Stivarga in patients with colorectal cancer after surgical removal of liver metastases and completion of all planned chemotherapy. The primary endpoint of the study is Disease Free Survival (DFS). DFS is defined as the time in days from date of randomization to date of first observed disease recurrence or death.

RELATED: Gastrointestinal Cancers Resource Center

The trial will enroll approximately 750 patients who will be randomized in a 1:1 ratio to receive either Stivarga or placebo. Patients will receive 160mg Stivarga or placebo. Both treatments will be followed by a low-fat meal for 3 weeks of treatment followed by 1 week without treatment.

Stivarga is already 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. It is also approved to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

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