Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Adv… (NCT04066504) | Clinical Trial Compass
CompletedNot Applicable
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
Germany323 participantsStarted 2019-03-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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).