A 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

Phase 2

Completed

Conditions: locally advanced and metastatic basal cell carcinoma
skin cancer
10040900

Registration Number: NL-OMON38204

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the efficacy of LDE225 when administered once daily, as measured by<br /><br>Objective Response Rate (ORR) in patients with locally advanced or metastatic<br /><br>BCC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the time to the first documented tumor response (TTR) as complete or<br /><br>partial response associated with 800 mg and 200 mg dose LDE225 therapy.<br /><br>To assess duration of overall response, i.e. partial response (PR) or complete<br /><br>response (CR) associated with 800 mg and 200 mg dose LDE225 therapy.<br /><br>To assess the effect of LDE225 treatment on progression-free survival (PFS).<br /><br>To assess overall survival (OS) associated with LDE225 treatment.<br /><br>Characterize the safety of LDE225 treatment.<br /><br>To further characterize the pharmacokinetics.</p><br>