Basal Cell Carcinoma
Conditions
Brief 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.
Interventions
DRUGVismodegib
Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Clinical Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) | From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years) |
| Time to Clinical Response as Assessed by Investigator According to RECIST v1.1 | From the date of first treatment until the date of first documented confirmed complete response (CR) or partial response (PR) (whichever occurs first) (up to approximately 3 years) |
| Duration of Clinical Response as Assessed by Investigator According to RECIST v1.1 | From the date of occurrence of first clinical response up to the date of progression or death from any cause (up to approximately 3 years) |
| Percentage of Participants who Experience a Recurrence | From Baseline up to end of study (up to approximately 3 years) |
| Progression-Free Survival (PFS) as Assessed by Investigator According to RECIST v1.1 | From the date of first treatment up to the date of progression or death from any cause (up to approximately 3 years) |
| Overall survival (OS) | From the date of first treatment until death due to any cause (up to approximately 3 years) |
| Percentage of Participants With Adverse Events | From Baseline up to end of study (up to approximately 3 years) |
| Duration of Vismodegib Treatment | Baseline up to approximately 3 years |
| Percentage of Participants With Vismodegib Treatment Interruption | Baseline up to approximately 3 years |
Countries
Sweden
Outcome results
None listed