Status:
COMPLETED
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
Lead Sponsor:
Sun Pharmaceutical Industries Limited
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
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) a...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 14 2025
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT04066504
Start Date
March 11 2019
End Date
March 14 2025
Last Update
June 24 2025
Active Locations (47)
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1
Katholisches Klinikum Bochum St. Josef-Hospital
Bochum, Germany
2
Elbe Kliniken Stade - Buxtehude GmbH
Buxtehude, Germany
3
Klinikum Darmstadt GmbH
Darmstadt, Germany, 64297
4
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
Dresden, Germany, 1307