NIELS: Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
Drug: Vismodegib
Participants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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) [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed IaBCC (inappropriate for surgery or radiotherapy)
-
Participant is not included in any other trial
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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
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Women who are pregnant or breastfeeding
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Women of childbearing potential who do not comply with the Vismodegib Pregnancy Prevention Programme
-
Coadministration of St John's wort (Hypericum perforatum)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie | Frankfurt | Germany | 60590 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML29670