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

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Response rate as assessed by the treating physician

Time frame: Approximately 12 months

Secondary outcomes

Duration of treatment

Time frame: Approximately 12 months
Duration of response as assessed by the treating physician

Time frame: Approximately 12 months
Incidence of adverse events

Time frame: Approximately 12 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: May 8, 2015
Registry last updated: Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed