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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02438644

Enrollment

Registered

2015-05-08

Start date

2015-06-30

Completion date

2017-07-26

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Response rate as assessed by the treating physician	Approximately 12 months

Secondary

Measure	Time frame
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

Outcome results