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
1 other identifier
observational
5
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2010
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedOctober 4, 2017
October 1, 2017
1 year
May 9, 2011
October 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: Incidence of adverse events
approximately 4 years
Secondary Outcomes (3)
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
Study Arms (1)
Cohort
Eligibility Criteria
Patients with advanced and/or metastatic renal cell carcinoma treated with Avastin and interferon alpha-2a
You may qualify if:
- 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
You may not qualify if:
- Contraindications to Avastin and/or interferon alpha-2a as per local label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Aurangabad, 43100, India
Unknown Facility
Delhi, 110085, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 11, 2011
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
October 4, 2017
Record last verified: 2017-10