Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

— NISSO  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04066504
• Other study ID #: CLDE225A2404
• Status: Active, not recruiting
• Start date: March 11, 2019
• Est. completion date: November 30, 2025

Study information

• Verified date: June 2024
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 323
• Est. completion date: November 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Drug:
• sonidegib
Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)

Locations

Country	Name	City	State
Germany	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
Germany	SRH Wald-Klinikum	Gera
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitaets-Hautklinik Kiel	Kiel
Germany	Klinikum Ludwigshafen gGmbH	Ludwigshafen
Germany	Universitaetsklinikum Schleswig-Holstein	Luebeck
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	Tuebingen
Germany	Universitätsklinikum Ulm	Ulm
Italy	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	Firenze
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
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas De Gran Canaria
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	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
Switzerland	Inselspital	Bern
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

Germany,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with AEs/SAEs	including on-treatment deaths and discontinuation due to AEs/SAEs	3 years
Secondary	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