locally advanced and metastatic basal cell carcinoma skin cancer
Conditions
Interventions
All enrolled patients will receive LDE225 at either 800 mg or 200 mg.
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patient is male or female * 18 years of age - Histologically confirmed diagnosis of locally advanced or metastatic BCC with measurable disease - WHO performance status * 2 - Adequate renal and liver functions
Exclusion criteria
Exclusion criteria: - Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data. - Patients who have previously been treated with systemic LDE225 or with other Hh pathway inhibitors. - Patients who have neuromuscular disorders or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis - Pregnant or nursing (lactating) women - Women of child-bearing potential, UNLESS they are using two forms of highly effective contraception - Fertile males not willing to use condoms throughout the study and for 3 months after
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of LDE225 when administered once daily, as measured by Objective Response Rate (ORR) in patients with locally advanced or metastatic BCC. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the time to the first documented tumor response (TTR) as complete or partial response associated with 800 mg and 200 mg dose LDE225 therapy. To assess duration of overall response, i.e. partial response (PR) or complete response (CR) associated with 800 mg and 200 mg dose LDE225 therapy. To assess the effect of LDE225 treatment on progression-free survival (PFS). To assess overall survival (OS) associated with LDE225 treatment. Characterize the safety of LDE225 treatment. To further characterize the pharmacokinetics. | — |
Countries
Netherlands
Outcome results
None listed