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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01351571

Enrollment

Registered

2011-05-11

Start date

2010-08-31

Completion date

2011-08-31

Last updated

2017-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	approximately 4 years

Secondary

Measure	Time frame
Progression-free survival: time from first drug administration to documented disease progression or death of any cause	approximately 4 years
Overall response rate: complete response or partial response according to RECIST criteria	approximately 4 years
Overall survival	approximately 4 years

Countries

India

Outcome results