CompletedNot Applicable

Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions

Germany53 participantsStarted 2016-04-29

Plain-language summary

The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Willing and able to provide informed consent * Age ≥ 18 years * laBCC (inappropriate for surgery or radiotherapy) * Patient is not included in any other trial * Male or female patient is included in the pregnancy prevention program, as determined by the German authority (BfArM) Exclusion Criteria: Patients, for whom treatment with Vismodegib is contraindicated according to the Summary of Product Characteristics (SmPC), which has been in effect at the time of treatment with Vismodegib, including: * Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. of the latest SmPC * Women who are pregnant or breast-feeding * Women of childbearing potential who do not comply with the Vismodegib (Erivedge) Pregnancy Prevention Programme * Coadministration of St John's wort (Hypericum perforatum)

What they're measuring

Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first)

Timeframe: up to 3 years from first dose Vismodegib

Trial details

NCT IDNCT02781389

SponsorUniversity Hospital, Essen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-05-31

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