CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 230 enrolled
Drug / intervention
LDE225drug
Likely dose
LDE225 200 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/NCT01327053
NCT01327053Phase 2Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Apr 1, 2011·Updated Aug 28, 2019

In Brief

A Phase 2 clinical trial evaluating LDE225 for Basal Cell Carcinoma. Completed, enrolled 230 participants across 62 sites in 12 countries.

Detailed Summary

This study assessed the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBasal Cell Carcinoma
CountriesAustralia, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2011
Enrollment StartJun 29, 2011
Primary CompletionJun 28, 2013
Study CompletionJun 29, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 15.3 years ago

Interventions

LDE225drug

LDE225 was administered orally, on a continuous once daily dosing schedule and was supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day of study visit, patients received a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients received 4 capsules of LDE225 and 200 mg dose arm patients received 1 LDE225 capsule + 3 placebo capsules.