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

Roche

Status: Completed

Conditions: Carcinoma, Basal Cell

Treatments: Drug: Vismodegib

Study type: Observational

Funder types: Industry

Identifiers

NCT02674009

ML29670

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

67 participants in 1 patient group

laBCC Participants

Description:

Participants with laBCC who received at least one dose of Vismodegib in routine clinical practice for 32 months (between 02 Aug 2013 and 31 Mar 2016).

Treatment:

Drug: Vismodegib