Avastin in Metastatic Renal Cancer

Renal Cell Cancer Clinical Trial

Official title:

AVASTIN® First Line in Metastatic Renal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627144
• Other study ID #: ML21519
• Status: Completed
• Phase: N/A
• First received: December 8, 2015
• Last updated: December 8, 2015
• Start date: January 2008
• Est. completion date: September 2014

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical Trial Summary

This is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous Avastin in combination with interferon alpha-2a for first-line treatment of participants with advanced and/or metastatic renal cell cancer (mRCC) in daily routine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed advanced and/or metastatic renal cell cancer

• No contraindications for Avastin according to summary of product characteristics (SmPC)

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer

Intervention

Drug:
• Avastin
Avastin will be administered at the recommended dose of 10 mg/kg of body weight once every 2 weeks as an intravenous infusion until disease progression.
• Interferon alpha-2a
Interferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with tumor response		Up to 24 months	No
Primary	Progression-free survival time		Up to 24 months	No
Primary	Cumulative dose of immunotherapy (interferon alpha-2a) in daily routine		Up to 24 months	No
Primary	Percentage of participants with at least one adverse event (AE)		Up to 24 months	No
Primary	Percentage of participants with causes for treatment withdrawal or modifications		Up to 24 months	No