An Observational Study of Avastin (Bevacizumab) and Interferon Alpha 2a in Patients With Metastatic Renal Cell Cancer (VERA)

Completed

• Conditions: Renal Cell Cancer

• Registration Number: NCT01392729
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This prospective observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with interferon alpha 2a in patients with previously untreated metastatic renal cell cancer. Data will be collected from each patient for up to 4 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Histologically confirmed metastatic renal cell cancer, clear cell type
• Eligible for treatment with Avastin and interferon alpha 2a according to local prescribing information

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Exclusion Criteria

• Contraindications for Avastin or interferon alpha 2a treatment according to local Summary of Product Characteristics
• Known hypersensitivity to Avastin and/or interferon alpha 2a or any of its excipients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	approximately 4 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	approximately 4 years
Response rate	approximately 4 years
Safety: Incidence of adverse events	approximately 4 years