LDE225 in adult elapsed patients or elderly leukemia patients.

• Research type

  Research Study

• Full title

  A Phase II multi-center, open label, randomized study to assess safety and efficacy of two different schedules of oral LDE225 in adult patients with elapsed/refractory or untreated elderly patients with acute leukemia.

• IRAS ID

  127191

• Contact name

  Nigel Russell

• Contact email

  nigel.russell@nottingham.ac.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-004022-21

• ISRCTN Number

  n/A

• Research summary

  This is a phase II multi-center, open label, randomized study to assess safety
  and efficacy of two different schedules of oral LDE225 in adult patients
  with relapsed/refractory or untreated elderly patients with acute leukemia. The purpose of this study is to see how safe and effective LDE225 is, in patients with Acute Leukaemia. Patients will receive LDE225 either once a day for the study duration or twice a day for 2 weeks then switch to once a day for the remaining duration. This study is randomised, and there is a 1:1 chance of receiving LDE225 once or twice a day. Patients will continue treatment until they no longer receive benefit, experience unacceptable side effects, withdraw their consent, early termination of the study or up to 53 weeks after the last patient is enrolled whichever occurs sooner. The study will include approximately 80 patients.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  13/SC/0310

• Date of REC Opinion

  12 Jul 2013

• REC opinion

  Further Information Favourable Opinion