Observational Study of Vismodegib (Erivedge) in Patients Treated in Argentina

Roche

Status: Completed

Conditions: Basal Cell Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT02438644

ML29740

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

Study Population

Description:

Patients who are prescribed vismodegib in Argentina, according to standard of care and in line with the current SPC and local labeling, are eligible for observation. Dosing and treatment duration of vismodegib are at the discretion of the physician in accordance with local clinical practice and local labeling. Only patients with laBCC or mBCC will be considered in the effectiveness analysis.