Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
NCT ID: NCT04066504
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
323 participants
OBSERVATIONAL
2019-03-11
2025-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sonidegib
Patients with laBCC undergoing sonidegib treatment in routine clinical practice
sonidegib
Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
Interventions
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sonidegib
Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Ralf Gutzmer
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik für Dermatologie, Venerologie, Allergologie und Phlebologie Johannes Wesling Klinikum Minden Mühlenkreiskliniken Universitätsklinikum der Ruhr-Universität Bochum
Locations
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Katholisches Klinikum Bochum St. Josef-Hospital
Bochum, , Germany
Elbe Kliniken Stade - Buxtehude GmbH
Buxtehude, , Germany
Klinikum Darmstadt GmbH
Darmstadt, , Germany
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
Dresden, , Germany
Helios Klinikum
Erfurt, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
SRH Wald-Klinikum
Gera, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaets-Hautklinik Kiel
Kiel, , Germany
Klinikum Ludwigshafen gGmbH
Ludwigshafen, , Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck, , Germany
Universitätsklinik Magdeburg
Magdeburg, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
Klinikum rechts der Isar
München, , Germany
Fachklinik Muenster-Hornheide
Münster, , Germany
Helios St. Elisabeth Klinik
Oberhausen, , Germany
Harzklinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , 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, , Italy
ASL1 Avezzano-Sulmona-L'Aquila
L’Aquila, , 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
Istituto Tumori Napoli Fondazione G. Pascale
Napoli, , Italy
Università Degli Studi di Napoli Federico II
Napoli, , Italy
AOU Maggiore della Carità - Università del Piemonte Orientale
Novara, , Italy
IDI
Roma, , Italy
Università Cattolica del Sacro Cuore
Roma, , Italy
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Complejo Hospitalario Universitario de Pontevedra
Pontevedra, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital General Universitari València
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Inselspital
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Countries
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References
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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.
Other Identifiers
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CLDE225A2404
Identifier Type: -
Identifier Source: org_study_id
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