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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonidegib | Patients with laBCC undergoing sonidegib treatment in routine clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sonidegib | Drug | Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with AEs/SAEs | including on-treatment deaths and discontinuation due to AEs/SAEs | 3 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with laBCC undergoing treatment with sonidegib.
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Gutzmer | Universitätsklinik für Dermatologie, Venerologie, Allergologie und Phlebologie Johannes Wesling Klinikum Minden Mühlenkreiskliniken Universitätsklinikum der Ruhr-Universität Bochum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katholisches Klinikum Bochum St. Josef-Hospital | Bochum | Germany | ||||
| Elbe Kliniken Stade - Buxtehude GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39538176 | Derived | Gutzmer R, Leiter U, Mohr P, Kahler KC, Ascierto PA, Scalvenzi M, Peris K, Perez-Pastor GM, Fernandez-de-Misa R, Botella-Estrada R, Hunger RE, Martelli S, Guneli N, Arntz R, Hauschild A. Interim analysis of the multinational, post-authorization safety study (NISSO) to assess the long-term safety of sonidegib in patients with locally advanced basal cell carcinoma. BMC Cancer. 2024 Nov 14;24(1):1401. doi: 10.1186/s12885-024-13101-z. |
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|
| Buxtehude |
| Germany |
| Klinikum Darmstadt GmbH | Darmstadt | 64297 | Germany |
| Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden | Dresden | 1307 | Germany |
| Helios Klinikum | Erfurt | 99089 | Germany |
| Universitaetsklinikum Essen | Essen | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79104 | Germany |
| SRH Wald-Klinikum | Gera | 07548 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover | Hanover | '30625 | Germany |
| Universitaets-Hautklinik Kiel | Kiel | Germany |
| Klinikum Ludwigshafen gGmbH | Ludwigshafen | Germany |
| Universitaetsklinikum Schleswig-Holstein | Lübeck | Germany |
| Universitätsklinik Magdeburg | Magdeburg | 39120 | Germany |
| Johannes Wesling Klinikum Minden | Minden | 32429 | Germany |
| Klinikum rechts der Isar | München | 80802 | Germany |
| Fachklinik Muenster-Hornheide | Münster | 48157 | Germany |
| Helios St. Elisabeth Klinik | Oberhausen | 46045 | Germany |
| Harzklinikum Dorothea Christiane Erxleben GmbH | Quedlinburg | 06484 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| I.R.C.C.S Istituto Tumori "Giovanni Paolo II" | Bari | Italy |
| ASST Spedali Civili di Brescia | Brescia | Italy |
| Azienda Toscana Centro - Università di Firenze | Florence | Italy |
| Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| ASL1 Avezzano-Sulmona-L'Aquila | L’Aquila | Italy |
| Ist. Scien. Romagnolo per lo Studio e la Cura dei Tumori - IRST | Meldola | 47014 | Italy |
| Forndazione I.R.C.C.S. Istituto nazionale dei tumori | Milan | 20133 | Italy |
| Istituto Tumori Napoli Fondazione G. Pascale | Naples | 80131 | Italy |
| Università Degli Studi di Napoli Federico II | Naples | Italy |
| AOU Maggiore della Carità - Università del Piemonte Orientale | Novara | Italy |
| IDI | Roma | 00167 | Italy |
| Università Cattolica del Sacro Cuore | Roma | 00168 | Italy |
| Hospital Germans Trias i Pujol | Badalona | 8916 | Spain |
| Hospital Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 8036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 8041 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrín | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Complejo Hospitalario Universitario de Pontevedra | Pontevedra | 36001 | Spain |
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | 38010 | Spain |
| Hospital General Universitari València | Valencia | 46014 | Spain |
| Hospital Universitario La Fe | Valencia | 46026 | Spain |
| Inselspital | Bern | Switzerland |
| Universitätsspital Zürich | Zurich | CH- 8091 | Switzerland |
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
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| ID | Term |
|---|---|
| C561435 | sonidegib |
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