A Double-blind, Randomized, Vehicle-controlled Proof of Concept (PoC) Study to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Topical Administrations of LDE225 (a Specific Smoothened Inhibitor) on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients Followed by an Open Label, Randomized Expansion Group to Test Two Different Strengths of an Improved LDE225 Formulation for Extended Treatment Durations

Trial Profile

A Double-blind, Randomized, Vehicle-controlled Proof of Concept (PoC) Study to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Topical Administrations of LDE225 (a Specific Smoothened Inhibitor) on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients Followed by an Open Label, Randomized Expansion Group to Test Two Different Strengths of an Improved LDE225 Formulation for Extended Treatment Durations

Completed
Phase of Trial: Phase II

Latest Information Update: 05 Nov 2015

At a glance

  • Drugs Sonidegib (Primary)
  • Indications Basal cell cancer; Basal cell nevus syndrome
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Novartis
  • Most Recent Events

    • 22 Dec 2012 New source identified and integrated (European Clinical Trials Database; EudraCT2008-005506-40)
    • 18 May 2011 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 18 May 2011 Actual end date (Aug 2010) added as reported by ClinicalTrials.gov.
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