LDE225 in patients with basal cell carcinoma

• Research type

  Research Study

• Full title

  A phase II, randomized double-blind study of efficacy and safety of two dose levels of LDE225 in patients with locally advanced or metastatic basal cell carcinoma.

• IRAS ID

  78204

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-022629-14

• Research summary

  This is a multi-center, adaptive, randomized double-blind Phase II study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic BCC. Approximately 120 patients will be enrolled in this study. All enrolled patients will be initially randomised in a 2:1 fashion to receiveLDE225 at either 800 mg or 200 mg on a continuous once daily dosing schedule (i.e. approximately 80 and 40 patients will be randomized to 800 mg and 200 mg, respectively).

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  11/YH/0121

• Date of REC Opinion

  22 Jun 2011

• REC opinion

  Further Information Favourable Opinion