Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma
1 other identifier
observational
47
1 country
8
Brief Summary
A retrospective medical record abstraction study of at least 200 advanced renal cell carcinoma patients treated in the following settings:
- Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line therapy (about 100 patients)
- Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as first-line therapy followed by Sunitinib (Sutent) as second-line therapy (about 100 patients)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2009
Typical duration for all trials
8 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
First Submitted
Initial submission to the registry
April 3, 2009
CompletedFirst Posted
Study publicly available on registry
April 6, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedNovember 14, 2013
November 1, 2013
1.8 years
April 3, 2009
November 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and efficacy of Nexavar as second-line therapy in patients with advanced renal cell carcinoma treated with Nexavar after first-line therapy with Sutent or Avastin.
6 months
Secondary Outcomes (1)
To evaluate safety and efficacy of Nexavar as first-line therapy in patients with advanced renal cell carcinoma and as first-line therapy followed by Sutent as second-line therapy in patients with advanced renal cell carcinoma.
6 months
Eligibility Criteria
Two hundred plus patients treated with Nexavar as first or second line therapy for advanced renal cell carcinoma.
You may qualify if:
- Eligible patient cases are those that have received Sorafenib (Nexavar) as second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line therapy or those patients that were treated with Sorafenib (Nexavar) as first-line therapy followed by Sunitinib (Sutent) as secondline therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Bayercollaborator
Study Sites (8)
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
St. Louis Cancer Care
Chesterfield, Missouri, 63017, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jeffrey F Patton, M.D.
SCRI Development Innovations, LLC
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2009
First Posted
April 6, 2009
Study Start
May 1, 2009
Primary Completion
February 1, 2011
Study Completion
August 1, 2011
Last Updated
November 14, 2013
Record last verified: 2013-11