TAC-101 as second line treatment in Hepatocellular Carcinoma

• Research type

  Research Study

• Full title

  A PHASE 2, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, INTERNATIONAL, MULTICENTER STUDY OF ORAL TAC 101 AS SECOND LINE TREATMENT IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA WHO RECEIVED SORAFENIB AS FIRST LINE THERAPY

• Sponsor organisation

  Taiho Pharma USA, Inc.

• Eudract number

  2007-007629-32

• ISRCTN Number

  N/A

• Research summary

  Liver cancer is the fifth most common cancer worldwide and the third most common cause of cancer-related death in the world. It is approximately 2.5 times more common among men than woman. The most important risk factors for (HCC) hepatocellular cancer (liver cancer) are hepatitis B virus (HBV), hepatitis C virus (HCV), and dietary fungal contamination. Other well-established risk factors include alcoholic liver disease and haemochromatosis (an hereditary disease that causes increased iron level in the body). Obesity, diabetes, smoking, oral contraceptive use, and inadequate intake of selenium and antioxidants also have been implicated as risk factors. The drug under study is a synthetic retinoid. Retinoids are naturally occurring and synthetic versions of vitamin A (retinol) that act as critical controls of many body processes. In the clinical setting, retinoids have demonstrated potential in the prevention and treatment of cancer. Currently there is no second line therapy available for hepatocellular cancer. It is hoped that the study drug treatment can extend overall survival after discontinuation of sorafenib. This study is designed to assess the survival benefit of the study drug as second line treatment in patients with HCC who received sorafenib as first line therapy. Patients will be randomised in a 1:1 ratio to receive either the study drug or placebo (dummy pill)Once randomised patients will take 2 tablets once a day with food for 14 days followed by a 7-day recovery period. This cycle will be repeated every 21 days.Treatment with study medication will continue until the patient has disease progression and/or, in the opinion of the Investigator, there is no clinical benefit to continue treatment. This study will be recruiting in London, Birmingham and Newcastle-Upon-Tyne in the UK.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  08/H1208/52

• Date of REC Opinion

  19 Feb 2009

• REC opinion

  Further Information Favourable Opinion