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

Completed

• Conditions: Basal Cell Carcinoma
• Interventions: Drug: sonidegib

• 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.

Study Timeline

• Study Start: 2019-03-11
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Primary Completion: 2025-03-14
• Study Completion: 2025-03-14
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

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).

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)

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

Scroll for more (37 remaining)