NCT01327053

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	LDE225	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.

Timeline

• Start date: 2011-06-29
• Primary completion: 2013-06-28
• Completion: 2018-06-29
• First posted: 2011-04-01
• Last updated: 2019-08-28
• Results posted: 2015-11-23

Locations

62 sites across 12 countries: United States, Australia, Belgium, Canada, France, Germany, Greece, Hungary, Italy, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study