Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT04066504
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04066504
Study Brief:
Protocol Section:
NCT04066504