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

Sun Pharma

Status: Completed

Conditions: Basal Cell Carcinoma

Treatments: Drug: sonidegib

Study type: Observational

Funder types: Industry

Identifiers

NCT04066504

CLDE225A2404

Details and patient eligibility

About

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.

Full 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.

Enrollment: 323 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

323 participants in 1 patient group

Sonidegib

Description:

Patients with laBCC undergoing sonidegib treatment in routine clinical practice

Treatment:

Drug: sonidegib