Pilot LDE225 in Locally Advanced or Metastatic BCC + Previously Tx Non-LDE225 Smoothened Inhibitors
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
This is a prospective single-center, open label, pilot study to investigate the safety and
efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma.
Primary Objectives:
• To explore the effects of oral LDE225 on the Progression Free Survival (PFS) of individuals
with locally advanced or metastatic BCC who have been previously treated with a non-LDE225
Smo inhibitor.
Secondary Objectives:
- To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation (Gii
1, 2, Patched 1,2 and Ki67) in individuals which are non-na"ive to Smo inhibitors other
than LDE225, at baseline and at end-of-treatment
- To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225
Smo inhibitor usage
- To assess the overall survival rates of individuals with locally advanced BCC or
metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with
LDE225