CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
LDE225 +1 moredrug
Likely dose
LDE225 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01350115
NCT01350115Phase 2Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted May 9, 2011·Updated Oct 19, 2015

In Brief

A Phase 2 clinical trial evaluating LDE225 and Placebo for Basal Cell Carcinoma and 2 related conditions. Completed, enrolled 10 participants across 6 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBasal Cell Carcinoma, Gorlin Syndrome, Nevoid Basal Cell Carcinoma Syndrome
CountriesAustria, Belgium, Canada, Germany
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2011
Enrollment StartApr 1, 2011
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.1 years ago

Interventions

LDE225drug

supplied as 100 mg capsules

Placebodrug

supplied in capsules