A Proof of Concept study using LDE225 on basal cell carcinomas

• Research type

  Research Study

• Full title

  A double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the efficacy, safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on sporadic superficial skin basal cell carcinomas (sBCC)

• IRAS ID

  34134

• Contact name

  Sean Whittaker

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-013665-26

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a proof of concept study involving the twice daily topical use of LDE225 in patients with superficial basal cell carcinoma. The primary objective of the study is to evaluate the safety and tolerability of the cream and the efficacy of it. It is hoped that in the UK 12 patients aged between 18 and 75 will be recruited from 3 centres in the UK. Patients must present with an area of 25cm2 on either the scalp, arm, front or back trunk or upper legs. There will be no comparison with another drug; the study is placebo-controlled and randomised. Each randomised patient will spend 16 weeks on the trial including a 21 day run in period.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/113

• Date of REC Opinion

  14 Jan 2010

• REC opinion

  Further Information Favourable Opinion