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NCT02438644 Clinical Trial

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

Basal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02438644
Other study ID # ML29740
Secondary ID
Status Completed
Phase N/A
First received May 6, 2015
Last updated February 22, 2018
Start date June 30, 2015
Est. completion date July 26, 2017

Study information
Verified date February 2018
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date July 26, 2017
Est. primary completion date July 26, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate as assessed by the treating physician Approximately 12 months
Secondary Duration of treatment Approximately 12 months
Secondary Duration of response as assessed by the treating physician Approximately 12 months
Secondary Incidence of adverse events Approximately 12 months
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