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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Gorlin Syndrome Participants With No Prior HPI Exposure | BCC participants with advanced disease and no Gorlin syndrome, and who have not been exposed previously to an Hedgehog Pathway Inhibitor (HPI) (e.g., Vismodegib, LDE225) prior to diagnosis of advanced disease; will receive vismodegib therapy in compliance with the physician's standard practice as per local label and will be followed-up for approximately 3 years or until death, withdrawal of consent, sponsor's decision, lost to follow-up or end of study. |
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| No Gorlin Syndrome Participants With Prior HPI Exposure | BCC participants with advanced disease and no Gorlin syndrome, and who have been exposed previously to an HPI (e.g., during clinical studies with vismodegib [SHH4476g {NCT00833417}, MO25616 {NCT01367665}] or LDE225); will receive vismodegib therapy in compliance with the physician's standard practice as per local label and will be followed-up for approximately 3 years or until death, withdrawal of consent, sponsor's decision, lost to follow-up or end of study. |
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| Gorlin Syndrome Participants With/Without Prior HPI Exposure | BCC participants with advanced disease and Gorlin syndrome, and who have or have not been previously exposed to an HPI (e.g., during clinical studies); will receive vismodegib therapy in compliance with the physician's standard practice as per local label and will be followed-up for approximately 3 years or until death, withdrawal of consent, sponsor's decision, lost to follow-up or end of study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vismodegib | Drug | Vismodegib therapy will be given in compliance with the physician's standard practice as per local label. |
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| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include adult participants with advanced BCC, in whom the treating physician has made the decision to commence vismodegib treatment (in accordance with the local label).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SU/Sahlgrenska, Hudkliniken | Gothenburg | 41345 | Sweden | |||
| Skånes Universitetssjukhus; Hudkliniken |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C538724 | HhAntag691 |
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|
| Baseline up to approximately 3 years |
| Percentage of Participants With Vismodegib Treatment Interruption | Baseline up to approximately 3 years |
| Lund |
| 222 41 |
| Sweden |
| Radiumhemmet | Solna | 171 64 | Sweden |
| Norrlands universitetssjukhus; Onkologkliniken | Umeå | Sweden |
| D018295 |
| Neoplasms, Basal Cell |