Basal Cell Carcinoma
Conditions
Keywords
locally advanced basal cell carcinoma, laBCC
Brief summary
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
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.
Interventions
DRUGsonidegib
Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with AEs/SAEs | 3 years | including on-treatment deaths and discontinuation due to AEs/SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with AEs of special interest (AESI) or populations | 3 years | 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 |
Countries
Germany, Italy, Spain, Switzerland
Contacts
PRINCIPAL_INVESTIGATORRalf Gutzmer
Universitätsklinik für Dermatologie, Venerologie, Allergologie und Phlebologie Johannes Wesling Klinikum Minden Mühlenkreiskliniken Universitätsklinikum der Ruhr-Universität Bochum
Outcome results
None listed