Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
NISSO
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)
1 other identifier
observational
323
4 countries
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2019
CompletedFirst Submitted
Initial submission to the registry
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2025
CompletedMarch 18, 2026
March 1, 2026
6 years
August 22, 2019
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with AEs/SAEs
including on-treatment deaths and discontinuation due to AEs/SAEs
3 years
Secondary Outcomes (1)
Proportion of patients with AEs of special interest (AESI) or populations
3 years
Study Arms (1)
Sonidegib
Patients with laBCC undergoing sonidegib treatment in routine clinical practice
Interventions
Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
Eligibility Criteria
Patients diagnosed with laBCC undergoing treatment with sonidegib.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Katholisches Klinikum Bochum St. Josef-Hospital
Bochum, Germany
Elbe Kliniken Stade - Buxtehude GmbH
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
Related Publications (1)
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.
PMID: 39538176DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralf Gutzmer
Universitätsklinik für Dermatologie, Venerologie, Allergologie und Phlebologie Johannes Wesling Klinikum Minden Mühlenkreiskliniken Universitätsklinikum der Ruhr-Universität Bochum
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2019
First Posted
August 26, 2019
Study Start
March 11, 2019
Primary Completion
March 14, 2025
Study Completion
March 14, 2025
Last Updated
March 18, 2026
Record last verified: 2026-03