E7050-701 - Phase Ib/II Study of E7050 Hepatocellular Carcinoma

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination with Sorafenib versus Sorafenib Alone as First Line Therapy in Patients with Hepatocellular Carcinoma

• IRAS ID

  83580

• Contact name

  Richard Hubner

• Sponsor organisation

  Eisai Inc

• Eudract number

  2011-000752-41

• Clinicaltrials.gov Identifier

  NCT01271504

• Research summary

  This is an Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7050 in Combination with Sorafenib versus Sorafenib Alone as First Line Therapy in Patients with Hepatocellular Carcinoma.Approximately 20 study sites globally will take part.This open-label, multicenter study will consist of 2 phases:? Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with sorafenib; ? Phase II: a randomized 2-arm design (E7050 plus sorafenib or sorafenib alone). The UK will only be taking part in Phase II. Approximately 10 to 15 patients will take part in Phase Ib. Approximately 80 patients will take part in Phase II. Patients will receive study treatment (E7050 plus sorafenib or sorafenib alone) for six 28-day cycles (24 weeks), until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the Investigator, lost to follow-up, or death, whichever occurs first. After 6 cycles, at the discretion of the Investigator and in consultation with the Medical Monitor, patients who are experiencing clinical benefit may continue E7050, with or without sorafenib(Arm 1) or may continue sorafenib alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated. Patients will be followed until death following completion of therapy. Radiographic scans will be required once every 8 weeks while patients are on therapy and every 12 weeks after stopping therapy until evidence of PD or until starting a next line of therapy, whichever occurs first. In patients experiencing PD, follow-up will be for survival only and radiographic scans are not required.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0772

• Date of REC Opinion

  6 Feb 2012

• REC opinion

  Further Information Favourable Opinion