Clinical trial · Observational
A Study to Assess the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Advanced Basal Cell Carcinoma (BCC)
A Prospective Observational Study of Erivedge® Treatment, Effectiveness, and Safety Outcomes in Patients With Advanced Basal Cell Carcinoma
NCT02371967CI-TRIAL-00047592ROSETTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vismodegib | Drug | Vismodegib | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- No Gorlin Syndrome Participants With No Prior HPI Exposure
- description
- 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.
- interventionNames
- Drug: Vismodegib
- label
- No Gorlin Syndrome Participants With Prior HPI Exposure
- description
- 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.
- interventionNames
- Drug: Vismodegib
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.