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

Study Timeline

• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-08
• Study Start: 2015-06-30
• Primary Completion: 2017-07-26
• Study Completion: 2017-07-26
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26

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

Exclusion Criteria

• None specified

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