Phase Ib/II E7080 Stage IV Melanoma

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 in Combination with Dacarbazine versus Dacarbazine Alone as First Line Therapy in Patients with Stage IV Melanoma

• IRAS ID

  48784

• Contact name

  Mark R Middleton

• Sponsor organisation

  Eisai Inc

• Eudract number

  2009-016049-24

• ISRCTN Number

  n/a

• Research summary

  The purpose of this study is to find out the safety, tolerability and maximum tolerated dose of investigational drug E7080 administered in combination with dacarbazine.The study consists of a phase 1b portion: a safety run-in period with 3 ascending doses of E7080 in combination with dacarbazine; and a phase II portion:which will involve patients receiving either E7080 in combination with dacarbazine or dacarbazine alone.This will be completed at sites in the UK, Europe and America

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  10/H1306/34

• Date of REC Opinion

  2 Jul 2010

• REC opinion

  Further Information Favourable Opinion