Brivanib versus Sorafenib in Liver Cancer Version 1.0

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Multi-center Phase III Study of Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma

• IRAS ID

  18825

• Contact name

  Philip J Johnson

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2008-003533-24

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Hepatocellular carcinoma (Liver Cancer) is one of most common cancers worldwide with an annual incidence of over 600,000 new cases. The vast majority of patients worldwide are diagnosed in later stages of the disease contributing to a high mortality rate. With limited treatment options for advanced stage patients, liver cancer remains an area of high unmet medical need. This study will compare the overall survival rate for patients assigned 1:1 to treatment with either Bristol Myers Squibb drug Brivanib or Sorafenibas, which is made by Bayer. Patients who have not received prior treatment will receive either Sorafenibas or Brivanib in order to compare tumour growth and overall survival. Both treatments are in tablet form. Cancer cells in a tumour need blood to supply the tumour with oxygen and nutrients to grow. The clinical trial will evaluate the ability of Brivanib to prevent cancer cells from getting the blood supply they need which in turn could slow down or inhibit these cells from growing. Approximately 1050 patients in total are expected to participate in the study, with 48 patients taking part in the UK. The spread or growth of tumour will be assessed by regular CT scans and patients may remain on study treatment after tumour progression if their doctor thinks it is in their best interest. The study will begin mid 2009 with a total duration of three years and estimated patient participation of up to 11 months or even longer. The research will be funded by Bristol-Myers Squibb and patients will be recruited in the UK from hospitals in England.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  09/H0305/88

• Date of REC Opinion

  10 Dec 2009

• REC opinion

  Further Information Favourable Opinion