1199.37 BIBF 1120 in advanced hepatocellular carcinoma

• Research type

  Research Study

• Full title

  A multicentre, open label, phase I/ randomized phase II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with oral sorafenib for advanced hepatocellular carcinoma patients

• IRAS ID

  21419

• Contact name

  Daniel Palmer

• Eudract number

  2009-011924-14

• ISRCTN Number

  N/A

• Research summary

  This study is an open label, phase I followed by a randomized phase II trial to determine the safety, pharmacokinetics (the action of drugs in the body over a period of time) and efficacy of BIBF 1120 compared to oral sorafenib for advanced hepatocellular (liver) cancer (HCC) patients. The phase I part is designed to determine the maximum tolerated dose and pharmacokinetics of BIBF 1120. This is followed by a randomised phase II part using the recommended dose of BIBF 1120 obtained from phase I part to compare with Sorafenib. Patients who have a histological confirmed diagnosis of HCC and are eligible may be considered for this study. The trial will be performed by Investigator'specialized in the treatment of HCC and this type of trial. The study is sponsored by Boehringer Ingelheim, a pharmaceutical company.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  09/H1208/45

• Date of REC Opinion

  5 Oct 2009

• REC opinion

  Further Information Favourable Opinion