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

NCT02438644 | Completed

• 1 other identifier: ML29740
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Response rate as assessed by the treating physician

  Approximately 12 months

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None specified

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: June 30, 2015
• Primary Completion: July 26, 2017
• Study Completion: July 26, 2017
• Last Updated: February 26, 2018

Record last verified: 2018-02