Overview
A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)
Status:
Completed
Completed
Trial end date:
2020-08-19
2020-08-19
Target enrollment:
0
0
Participant gender:
All
All
Summary
This prospective, observational, cohort study is designed to assess the effectiveness and safety outcomes of vismodegib and to assess actual day-to-day disease and participant management by the physician.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La Roche
Criteria
Inclusion Criteria:- BCC that meets one of the study's pre-specified cohort definitions
- Physician's decision to treat participant with vismodegib as per local label
- Participant who has not participated in a clinical trial within 90 days prior to study
enrollment, with the exception of participants who meet the criteria for Cohort 2 (No
Gorlin Syndrome Participants With Prior HPI Exposure)
Exclusion Criteria:
- Female participants are excluded if they are pregnant or if they plan to become
pregnant during treatment or within 2 years after end of treatment
- Male participants with female partners of childbearing potential are excluded if they
plan to impregnate their partner during treatment or within 2 months after end of
treatment