Bayer HealthCare has kicked off a global Phase III trial of Stivarga (regorafenib) in colorectal cancer patients whose disease has spread to the liver.
The randomised, double-blind, placebo-controlled COAST study is designed to assess the effect of adjuvant treatment with the drug in patients whose liver tumours have been removed.
The primary endpoint of the study - which intends to enrol around 750 patients across sites in North America, Brazil, Europe, Asia, Israel and Australia - is Disease Free Survival (as assessed by the investigator).
Colorectal cancer is the third most commonly diagnosed cancer and the third leading cause of cancer death in the US, in both men and women. Around 50% of colon cancer patients will be diagnosed with liver metastases, either at the time of diagnosis or due to recurrent disease, illustrating the scale of the patient population.
Stivarga is already approved in the US to treat two different tumour types:
- in 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; and
- and to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumour (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.