Clinical trial · Observational
Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)
Non-Interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions (NIELS)
NCT02674009CI-TRIAL-00038582NIELScompletedClinicalTrials.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 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.
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 |
|---|---|---|---|
| Carcinoma, Basal Cell | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vismodegib | Drug | Vismodegib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- laBCC Participants
- description
- 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).
- interventionNames
- Drug: Vismodegib
Primary outcomes (1)
- measure
- 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
- timeFrame
- From first objective response until disease progression or death from any cause, up to 3 years
Secondary outcomes (7)
- measure
- Percentage of Participants with Objective Response (CR or PR) as Determined by the Physician
- timeFrame
- From date of first therapy until disease progression or death, whichever occurs first (up to 3 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.