The regorafenib in patients with hepatocellular carcinoma.

• Research type

  Research Study

• Full title

  A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib.

• IRAS ID

  119662

• Contact name

  Paul Ross

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2012-003649-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver. It is the fifth most common cancer in men (523 000 cases, 7.9% of the total), the seventh in women (226 000 cases, 6.5% of the total), and the third most common cause of cancer-related death.The purpose of this study is to assess an experimental drug called regorafenib in combination with best supportive care. This study is to see if regorafenib is safe and if it slows down the growth of tumours, or even shrinks the tumour, and if this results in increased survival. This placebo controlled phase III study plans to recruit adult patients diagnosed with Hepatocellular carcinoma (HCC) and recently failed treatment with sorafenib. Globally 530 patients will be randomised to receive regorafenib (the active study drug) or placebo tablets (a dummy medicine).Regorafenib or placebo tablets will be taken orally (by mouth) once a day (4 tablets) in the morning for three weeks, followed by one week where no drug is taken. This treatment usually continues until the disease gets worse or the patient wants to stop treatment. During the study a number of assessments will be done, including: tumour assessments (in line with standard practice at the study centre) electrocardiogram, physical examinations and blood tests.If participant'stop treatment for any reason, they will need to return to the hospital/clinic within 14 days of permanently stopping treatment for a number of safety assessments. There will also be a safety follow-up 30 days after stopping treatment.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  13/LO/0150

• Date of REC Opinion

  29 Mar 2013

• REC opinion

  Further Information Favourable Opinion