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

• Status: Completed
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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)