Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma

Study Overview
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Brief Summary
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Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary to AEs.

Detailed Description
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This is a non-interventional, multinational, multi-center post-authorization safety study (PASS), to assess the safety of sonidegib administered in routine clinical practice in patients with laBCC who are not amendable to curative surgery or radiation therapy. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. For this study, each enrolled patient will be followed up for 3 years after enrollment.

Official Title
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A Non-interventional, Multi-national, Multi-center Post-authorization Safety Study (PASS) to Assess the Long Term Safety and Tolerability of Odomzo (Sonidegib) Administered in Patients With Locally Advanced Cell Carcinoma (laBCC)

Conditions
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Basal Cell Carcinoma

Intervention / Treatment
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* Drug: sonidegib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent or equivalent document (e.g., written information) as per country regulation Patients aged 18 years or older with a diagnosis of laBCC who are not amenable to curative surgery or radiation therapy Patients must be treated with sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted) Sonidegib treatment must be started either at the first visit for this study or prior to study entry. Exclusion Criteria: Patients treated with any hedgehog pathway inhibitor besides sonidegib within 3 months prior to study entry Patients currently enrolled in an interventional clinical trial Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC) Pregnancy and breast-feeding Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (as defined in sections 4.4 and 4.6 of the approved SmPC). Male patients who are unable to follow or comply with the required contraception measures (as defined in sections 4.4 and 4.6 of the approved SmPC).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sonidegib<br>Patients with laBCC undergoing sonidegib treatment in routine clinical practice | Drug: sonidegib<br>* Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)<br>* Other names: LDE225;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with AEs/SAEs | including on-treatment deaths and discontinuation due to AEs/SAEs | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with AEs of special interest (AESI) or populations | in patients with: relevant polymorphism, ≥65 yrs, hepatic or renal impairment, female patients with child bearing potential using anticonceptives, anemia (hemoglobin <9 g/dL), recent myocardial ischemia or cardiac failure, concomitant medications with known risk of creatine kinase elevation | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced basal cell carcinoma, laBCC