Basal Cell Carcinoma Clinical Trial
Official title:
A Pilot Open-Label Study to Examine the Safety and Efficacy of Oral LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma Who Have Been Previously Treated With Non-LDE225 Smoothened Inhibitor(s)
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
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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