An Observational Study of Avastin (Bevacizumab) in Combination With Interferon Alpha-2a as First-Line Treatment in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

Renal Cell Cancer Clinical Trial

Official title:

An Open Label, Prospective, Observational, Non-interventional Study of Bevacizumab in Combination With Interferon Alpha-2a for the First-line Treatment of Patients With Advanced and/or Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351571
• Other study ID #: ML25251
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: October 2, 2017
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with interferon alpha-2a as first-line treatment in patients with advanced and/or metastatic renal cell carcinoma. Data will be collected from each patient as per routine clinical practice of the Investigator (maximum of 52 weeks, until disease progression /unacceptable toxicity or withdrawal of consent) and/or based on the local label.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Advanced and/or metastatic renal cell carcinoma

• Receiving first-line treatment with Avastin and interferon alpha-2a according to standard of care and current local label

• At least one measurable and non-measurable lesion according to RECIST criteria

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Adequate bone marrow, renal and liver function

Exclusion Criteria:

• Contraindications to Avastin and/or interferon alpha-2a as per local label

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

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 4 years
Secondary	Progression-free survival: time from first drug administration to documented disease progression or death of any cause		approximately 4 years
Secondary	Overall response rate: complete response or partial response according to RECIST criteria		approximately 4 years
Secondary	Overall survival		approximately 4 years