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

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.

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma

• Study Type: Observational
• Enrollment (Actual): 75

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is characterized by patients who are prescribed vismodegib in Argentina, according to standard of care and in line with the current SPC and local labeling. Data collection will be prospective except in the cases when a treating physician contacts the vendor for the first time after the patient has started treatment with vismodegib. In these cases the vendor will retrospectively collect data from the start of treatment. Only patients with laBCC or mBCC will be considered in the effectiveness analysis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Study Population; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2015
• Primary Completion (ACTUAL): July 26, 2017
• Study Completion (ACTUAL): July 26, 2017

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (ESTIMATE): May 8, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma, Basal Cell
• Other Study ID Numbers: ML29740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED