E7080-G000-304 - Unresectable Hepatocellular Carcinoma

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma

• IRAS ID

  133364

• Contact name

  Debashis Sarker

• Contact email

  debashis.sarker@kcl.ac.uk

• Sponsor organisation

  Eisai Ltd

• Eudract number

  2012-002992-33

• Clinicaltrials.gov Identifier

  NCT01761266

• Clinicaltrials.gov Identifier

  115650, IND Number

• Duration of Study in the UK

  2 years, 10 months, 1 days

• Research summary

  This study will compare the effectiveness and safety of an investigational drug called lenvatinib, versus standard treatment sorafenib, in patients with unresectable hepatocellular carcinoma (Cancer of the Liver that cannot be treated with surgery)

  Approximately 940 subjects will take part in this study in about 150 study centers in North America, Europe and Asia Pacific.

  Subjects will be randomly assigned to either of the following treatment groups:

  ● Lenvatinib: 12 mg (or 8 mg) once daily by mouth
  ● Sorafenib: 400 mg twice daily by mouth

  There is a 1 in 2 chance that patients will receive lenvatinib and a 1 in 2 chance that patients will receive sorafenib. Patients will receive either lenvatinib or sorafenib until disease progression. The maximum estimated period for each subject on study treatment is anticipated to be approximately 18 months.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  13/LO/1050

• Date of REC Opinion

  4 Sep 2013

• REC opinion

  Further Information Favourable Opinion