Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laBCC Participants | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vismodegib | Drug | Participants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling. |
|
| Measure | Description | 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 |
| Measure | Description | 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) |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Participants receiving/having received Vismodegib for treatment of laBCC according to the German label and in line with the current Summary of Product Characteristics (SmPC) and who have no contraindication to Vismodegib therapy as per the local label are eligible for this non-interventional study if written informed consent is provided.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie | Frankfurt | 60590 | Germany |
Not provided
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C538724 | HhAntag691 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| 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 |
| 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 |
| Percentage of Participants with Adverse Events | From Baseline up to 3 years |
| D018295 |
| Neoplasms, Basal Cell |