- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351571
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
October 2, 2017 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aurangabad, India, 43100
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Delhi, India, 110085
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with advanced and/or metastatic renal cell carcinoma treated with Avastin and interferon alpha-2a
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Safety: Incidence of adverse events
Time Frame: approximately 4 years
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approximately 4 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Progression-free survival: time from first drug administration to documented disease progression or death of any cause
Time Frame: approximately 4 years
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approximately 4 years
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Overall response rate: complete response or partial response according to RECIST criteria
Time Frame: approximately 4 years
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approximately 4 years
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Overall survival
Time Frame: approximately 4 years
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approximately 4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
May 9, 2011
First Submitted That Met QC Criteria
May 10, 2011
First Posted (Estimate)
May 11, 2011
Study Record Updates
Last Update Posted (Actual)
October 4, 2017
Last Update Submitted That Met QC Criteria
October 2, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML25251
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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