Clinical trial NCT04066504: Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Basal Cell Carcinoma
Keywords: locally advanced basal cell carcinoma
laBCC
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with laBCC undergoing treatment with sonidegib.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of patients with AEs/SAEs
timeFrame: 3 years
Secondary outcomes:
measure: Proportion of patients with AEs of special interest (AESI) or populations
timeFrame: 3 years
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum St. Josef-Hospital
city: Buxtehude
country: Germany
facility: Elbe Kliniken Stade - Buxtehude GmbH
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH
city: Dresden
country: Germany
facility: Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
city: Erfurt
country: Germany
facility: Helios Klinikum
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Gera
country: Germany
facility: SRH Wald-Klinikum
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Universitaets-Hautklinik Kiel
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen gGmbH
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Magdeburg
country: Germany
facility: Universitätsklinik Magdeburg
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Münster
country: Germany
facility: Fachklinik Muenster-Hornheide
city: Oberhausen
country: Germany
facility: Helios St. Elisabeth Klinik
city: Quedlinburg
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben GmbH
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Bari
country: Italy
facility: I.R.C.C.S Istituto Tumori "Giovanni Paolo II"
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
city: Firenze
country: Italy
facility: Azienda Toscana Centro - Università di Firenze
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: L'Aquila
country: Italy
facility: ASL1 Avezzano-Sulmona-L'Aquila
city: Meldola
country: Italy
facility: Ist. Scien. Romagnolo per lo Studio e la Cura dei Tumori - IRST
city: Milan
country: Italy
facility: Forndazione I.R.C.C.S. Istituto nazionale dei tumori
city: Napoli
country: Italy
facility: Istituto Tumori Napoli Fondazione G. Pascale
city: Napoli
country: Italy
facility: Università Degli Studi di Napoli Federico II
city: Novara
country: Italy
facility: AOU Maggiore della Carità - Università del Piemonte Orientale
city: Roma
country: Italy
facility: IDI
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario de Pontevedra
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Valencia
country: Spain
facility: Hospital General Universitari València
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Bern
country: Switzerland
facility: Inselspital
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Universitätsklinik für Dermatologie, Venerologie, Allergologie und Phlebologie Johannes Wesling Klinikum Minden Mühlenkreiskliniken Universitätsklinikum der Ruhr-Universität Bochum
name: Ralf Gutzmer
role: PRINCIPAL_INVESTIGATOR
References: