CompletedNot Applicable

Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)

Germany67 participantsStarted 2015-09-17

Plain-language summary

The primary purpose for this multi-center, non-interventional study is to evaluate the duration of response defined as duration from first documented response of complete response (CR) or partial response (PR) until disease progression (as determined by the treating physician) for participants with laBCC.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Histologically confirmed IaBCC (inappropriate for surgery or radiotherapy) * Participant is not included in any other trial * Male or female participants are included in the pregnancy prevention program Exclusion Criteria: Participants for whom treatment with Vismodegib is contraindicated according to the 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 * Women who are pregnant or breastfeeding * Women of childbearing potential who do not comply with the Vismodegib Pregnancy Prevention Programme * Coadministration of St John's wort (Hypericum perforatum)

What they're measuring

Duration of Response, Defined as the Time from the First Assessment of CR or PR until Disease Progression or Death from any Cause, Whichever Occurs First

Timeframe: From first objective response until disease progression or death from any cause, up to 3 years

Trial details

NCT IDNCT02674009

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-03-31

View on ClinicalTrials.gov More Carcinoma, Basal Cell trials