MedTrace Logo

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

NCT04066504 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 323

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

sonidegib

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

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Principal Investigators

  • Ralf Gutzmer · Universitätsklinik für Dermatologie, Venerologie, Allergologie und Phlebologie Johannes Wesling Klinikum Minden Mühlenkreiskliniken Universitätsklinikum der Ruhr-Universität Bochum

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2025-03-14
Completion
2025-03-14

Countries

  • Germany
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066504 on ClinicalTrials.gov