Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
- Registration Number
- NCT04066504
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 323
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sonidegib sonidegib Patients with laBCC undergoing sonidegib treatment in routine clinical practice
- Primary Outcome Measures
Name Time Method Proportion of patients with AEs/SAEs 3 years including on-treatment deaths and discontinuation due to AEs/SAEs
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (47)
ASST Spedali Civili di Brescia
🇮🇹Brescia, Italy
Universitaets-Hautklinik Kiel
🇩🇪Kiel, Germany
Klinikum rechts der Isar
🇩🇪München, Germany
Klinikum Darmstadt GmbH
🇩🇪Darmstadt, Germany
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Helios Klinikum
🇩🇪Erfurt, Germany
ASL1 Avezzano-Sulmona-L'Aquila
🇮🇹L'Aquila, Italy
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
🇩🇪Dresden, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Klinikum Ludwigshafen gGmbH
🇩🇪Ludwigshafen, Germany
Katholisches Klinikum Bochum St. Josef-Hospital
🇩🇪Bochum, Germany
Elbe Kliniken Stade - Buxtehude GmbH
🇩🇪Buxtehude, Germany
Università Degli Studi di Napoli Federico II
🇮🇹Napoli, Italy
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Ist. Scien. Romagnolo per lo Studio e la Cura dei Tumori - IRST
🇮🇹Meldola, Italy
Forndazione I.R.C.C.S. Istituto nazionale dei tumori
🇮🇹Milan, Italy
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
SRH Wald-Klinikum
🇩🇪Gera, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Fachklinik Muenster-Hornheide
🇩🇪Münster, Germany
I.R.C.C.S Istituto Tumori "Giovanni Paolo II"
🇮🇹Bari, Italy
Azienda Toscana Centro - Università di Firenze
🇮🇹Firenze, Italy
Complejo Hospitalario Universitario de Pontevedra
🇪🇸Pontevedra, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Harzklinikum Dorothea Christiane Erxleben GmbH
🇩🇪Quedlinburg, Germany
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Santa Cruz De Tenerife, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
IDI
🇮🇹Roma, Italy
Università Cattolica del Sacro Cuore
🇮🇹Roma, Italy
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Inselspital
🇨🇭Bern, Switzerland
Hospital General Universitari València
🇪🇸Valencia, Spain
Istituto Tumori Napoli Fondazione G. Pascale
🇮🇹Napoli, Italy
AOU Maggiore della Carità - Università del Piemonte Orientale
🇮🇹Novara, Italy
Universitaetsklinikum Schleswig-Holstein
🇩🇪Luebeck, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinik Magdeburg
🇩🇪Magdeburg, Germany
Helios St. Elisabeth Klinik
🇩🇪Oberhausen, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany