Observational Study of Vismodegib (Erivedge) in Patients Treated in Argentina
Completed
- Conditions
- Basal Cell Carcinoma
- Registration Number
- NCT02438644
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational, noninterventional study is designed to further characterize the effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is estimated to be approximately 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
- Argetine patients prescribed vismodegib according to standard of care and in line with Summary of Product Characteristics (SPC) and local labeling
- Diagnosis of laBCC or mBCC for the effectiveness analysis
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Exclusion Criteria
- None specified
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate as assessed by the treating physician Approximately 12 months
- Secondary Outcome Measures
Name Time Method Duration of treatment Approximately 12 months Duration of response as assessed by the treating physician Approximately 12 months Incidence of adverse events Approximately 12 months