NCT01350115

Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

A Phase II, Double-blind, Randomized, Proof-of-Concept, Dose-ranging Trial Evaluating the Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Adult Patients With Nevoid Basal Cell Carcinoma Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a phase II, double-blind, randomized, proof-of-concept, dose-ranging trial evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult patients with NBCCS. This was an exploratory study designed to demonstrate preliminary efficacy of LDE225 in this indication. This study included a Screening period of approximately 4 weeks, treatment period duration of 12 weeks with initial follow-up of approximately 6-8 weeks followed by a long-term follow-up period.

Conditions

• Basal Cell Carcinoma
• Gorlin Syndrome
• Nevoid Basal Cell Carcinoma Syndrome

Interventions

Type	Name	Description
DRUG	LDE225	supplied as 100 mg capsules
DRUG	Placebo	supplied in capsules

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-05-09
• Last updated: 2015-10-19
• Results posted: 2015-10-19

Locations

6 sites across 4 countries: Austria, Belgium, Canada, Germany