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

Renal Cell Cancer Clinical Trial

Official title:

An Open Label, Prospective, Observational, Local, Non-interventional Study of BeVacizumab (Avastin) and IntErpherone (IFN) Alpha 2a in Patients With Metastatic and Locally Advanced Renal Cell CAncer (VERA Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392729
• Other study ID #: ML25255
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: November 1, 2016
• Start date: September 2010
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Agency of Medicine and Medical Devices (MAMMD)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		approximately 4 years	No
Secondary	Overall survival		approximately 4 years	No
Secondary	Response rate		approximately 4 years	No
Secondary	Safety: Incidence of adverse events		approximately 4 years	No