Clinical trial · Observational
Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions
Non-interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions
NCT02781389CI-TRIAL-00052095JONAScompletedClinicalTrials.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)
The aim of this non-interventional study is to provide further data on the utilization, effectiveness, safety and clinical benefit including duration of response of Vismodegib for treatment of locally advanced basal cell carcinoma (laBCC), inappropriate for surgery or radiotherapy under real world clinical conditions.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary effectiveness measure: duration of response (partial or complete) until progression, death or up to 3 years from first dose Vismodegib (whichever occurs first)
- timeFrame
- up to 3 years from first dose Vismodegib
- description
- The primary effectiveness measure for this study is as follows: • To evaluate the duration of response, defined as duration from first documented complete response (CR) or first documented partial response (PR), whichever cam first, until disease progression (as determined by the treating physician), or death of any reason or up to 3 years from first dose Vismodegib, whichever occurs first, for laBCC patients.
Secondary outcomes (6)
- measure
- Secondary effectiveness measure: - objective response rate
- timeFrame
- up to 3 years from first dose Vismodegib
- description
- number of patients with complete response or partial response as determined by the treating physician by clinical assessment, histological assessment, imaging assessment
- measure
- Secondary effectiveness measure: - time to response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to provide informed consent * Age ≥ 18 years * laBCC (inappropriate for surgery or radiotherapy) * Patient is not included in any other trial * Male or female patient is included in the pregnancy prevention program, as determined by the German authority (BfArM) Exclusion Criteria: Patients, for whom treatment with Vismodegib is contraindicated according to the Summary of Product Characteristics (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 listed in section 6.1. of the latest SmPC * Women who are pregnant or breast-feeding * Women of childbearing potential who do not comply with the Vismodegib (Erivedge) Pregnancy Prevention Programme * Coadministration of St John's wort (Hypericum perforatum)
References
Publications (0)
Data not yet available
No reference posted for this study.