NCT04066504

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 323 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	sonidegib	Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)

Timeline

• Start date: 2019-03-11
• Primary completion: 2025-03-14
• Completion: 2025-03-14
• First posted: 2019-08-26
• Last updated: 2026-03-18

Locations

47 sites across 4 countries: Germany, Italy, Spain, Switzerland