Carcinoma, Basal Cell
Conditions
Brief 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.
Interventions
DRUGVismodegib
Participants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling.
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
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | From first objective response until disease progression or death from any cause, up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Objective Response (CR or PR) as Determined by the Physician | From date of first therapy until disease progression or death, whichever occurs first (up to 3 years) |
| Percentage of Participants with Disease Control (CR, PR, or Stable Disease) | From date of first therapy until disease progression or death, whichever occurs first (up to 3 years) |
| Percentage of Participants with Disease Reccurence, Defined as Participants who Achieve CR and later Progress | From date of first therapy until disease progression or death, whichever occurs first (up to 3 years) |
| Percentage of Participants with Adverse Events | From Baseline up to 3 years |
| Overall Survival | From the date of the first therapy to death from any cause, up to 3 years |
| Time to Response | From the date of first therapy to first confirmed CR or PR whichever occurs first, up to 3 years |
| Progression-Free Survival, Evaluated According to Physician's Assessments | From the date of first therapy to disease progression or death from any cause, up to 3 years |
Countries
Germany
Outcome results
None listed