CHR258 in HCC

• Research type

  Research Study

• Full title

  A PHASE I/II DOSE ESCALATION TRIAL OF HDAC INHIBITOR TEFINOSTAT (CHR-2845) FOR CANCER ASSOCIATED INFLAMMATION IN HEPATOCELLULAR CARCINOMA

• IRAS ID

  97042

• Contact name

  Thorsten Hagemann

• Sponsor organisation

  Queen Mary, University of London

• Eudract number

  2012-000326-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Patients with primary liver cancer are difficult to treat and almost all die of their disease. Sorafenib is the only registered treatment in the UK for this group of patients and only provides a limited survival benefit. Sorafenib is not NICE approved in this setting. In addition, a recent publication has demonstrated that sorafenib treatment in a murine model of HCC increased cancer inflammation and promoted disease recurrence and progression. Therefore, there is a need for other treatment options to be developed in this group of patients. Tefinostat is a novel drug that blocks enzymes called histone deacetylases. Cells need these enzymes to grow and divide, blocking them may stop cancer growing. Drugs that block these enzymes are called HDAC inhibitors. This study aims to define the maximum administered dose (MAD) and maximum tolerated dose (MTD) of tefinostat in patients with advanced Hepatocellular Carcinoma (HCC), a type of liver cancer. The study will then go on to assess the safety and tolerability of the MTD of tefinostat in HCC. A maximum of 69 patients will be enrolled into this study at 3 institutions throughout the UK.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/0794

• Date of REC Opinion

  30 Jul 2012

• REC opinion

  Further Information Favourable Opinion