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Published on 21 May 2013

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Phase III trial of regorafenib in patients with advanced liver cancer

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Bayer HealthCare has announced that the company has started to enrol patients in an international Phase III trial to evaluate the efficacy and safety of regorafenib for the treatment of patients with hepatocellular carcinoma (HCC) who have progressed on sorafenib treatment.
Regorafenib is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumour growth and progression – angiogenesis, oncogenesis and maintenance of the tumour microenvironment.
“With sorafenib being a major advance in the treatment of unresectable HCC, Bayer remains committed to developing other treatment options, as there is a high unmet medical need for patients with advanced liver cancer whose disease has progressed after treatment with sorafenib,” said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “This international Phase III trial further broadens Bayer’s extensive and ongoing clinical development program for regorafenib and underscores Bayer’s commitment to developing novel treatment options, particularly for patients with difficult-to-treat cancers.” 
About the Phase III Study
The RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] clinical trial is a randomised, double blind, placebo controlled, multicentre Phase III study of regorafenib in patients with hepatocellular carcinoma whose disease has progressed after treatment with sorafenib. The trial will enrol approximately 530 patients who will be randomised in a 2:1 ratio to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC.
Patients will receive 160 mg regorafenib once daily, for 3 weeks on/1week off, or placebo. The primary endpoint of the study is overall survival, and secondary endpoints are time to progression, progression-free survival, objective tumour response rate and disease control rate. Safety and tolerability of the treatment groups will also be continously monitored.
The study will be conducted in North America, South America, Europe, Asia and Australia. For further information about the study, please visit:
www.clinicaltrials.gov


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