Observational Study of the Effectiveness and Safety of Vismodegib (Erivedge) in Patients Treated in Argentina

Hoffmann-La Roche0 sites75 target enrollmentJune 30, 2015

ConditionsBasal Cell Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Basal Cell Carcinoma
Sponsor: Hoffmann-La Roche
Enrollment: 75
Primary Endpoint: Response rate as assessed by the treating physician
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 30, 2015

End Date

July 26, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Response rate as assessed by the treating physician

Time Frame: Approximately 12 months

Secondary Outcomes

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)