Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
1 other identifier
interventional
2,567
2 countries
320
Brief Summary
This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2005
Typical duration for phase_3
320 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2005
CompletedFirst Posted
Study publicly available on registry
May 17, 2005
CompletedStudy Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedAugust 6, 2014
August 1, 2014
2 years
May 16, 2005
August 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Safety parameters
From signing consent to 30 days after last dose of study drug
Secondary Outcomes (1)
Limited radiological evaluations
At baseline, than every 8 weeks after start of sorafenib
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Multi kinase inhibitor: 400 mg of Sorafenib, orally, twice a day, on a continuous basis as a single agent for the treatment of advanced RCC
Eligibility Criteria
You may qualify if:
- Patients with advanced (unresectable, recurrent or metastatic) RCC
- Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy
- Patients with an ECOG performance status of 0-2
- Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib
- Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice
You may not qualify if:
- Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
- Patients who have participated in any other sorafenib trial
- Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
- Life expectancy of less than two months
- Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
- Patients with active coronary artery disease or ischemia
- Patients with Child-Pugh class C hepatic impairment
- Patients with severe renal impairment or who require dialysis
- Patients with active uncontrolled hypertension
- Patients with recent or active bleeding diathesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (320)
Unknown Facility
Bessemer, Alabama, 35023, United States
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Cullman, Alabama, 35058, United States
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Mobile, Alabama, 36608, United States
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Anchorage, Alaska, 99508, United States
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Glendale, Arizona, 85304, United States
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Scottsdale, Arizona, 85258, United States
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Tucson, Arizona, 85704, United States
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Conway, Arkansas, 72034, United States
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Hot Springs, Arkansas, 71913, United States
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Little Rock, Arkansas, 72205, United States
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Pine Bluff, Arkansas, 71603, United States
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Springdale, Arkansas, 72764, United States
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Bakersfield, California, 93309, United States
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Beverly, California, 90211, United States
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Concord, California, 94520, United States
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Duarte, California, 91010, United States
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Fountain Valley, California, 92708, United States
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Glendale, California, 91206, United States
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Highland, California, 92346, United States
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La Jolla, California, 92037, United States
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La Jolla, California, 92093, United States
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Loma Linda, California, 92357, United States
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Long Beach, California, 90813, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90033, United States
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Los Angeles, California, 90057, United States
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Los Angeles, California, 90095, United States
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Newport Beach, California, 92663, United States
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Orange, California, 92868, United States
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Rancho Mirage, California, 92270, United States
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Sacramento, California, 95823, United States
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Salinas, California, 93901, United States
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San Diego, California, 92120, United States
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San Francisco, California, 94115, United States
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Stanford, California, 94305, United States
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Sunnyvale, California, 94086, United States
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Vallejo, California, 94589, United States
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Aurora, Colorado, 80045, United States
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Colorado Springs, Colorado, 80907, United States
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Denver, Colorado, 80210, United States
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Denver, Colorado, 80218, United States
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Glenwood Springs, Colorado, 81601, United States
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Lafayette, Colorado, 80026, United States
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Loveland, Colorado, 80538, United States
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Greenwich, Connecticut, 06830, United States
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Hartford, Connecticut, 06105, United States
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Middletown, Connecticut, 06457, United States
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New Britain, Connecticut, 06050, United States
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New Haven, Connecticut, 6520, United States
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Norwich, Connecticut, 06360, United States
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Southington, Connecticut, 06489, United States
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Stamford, Connecticut, 06902, United States
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Trumbull, Connecticut, 06611, United States
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Boca Raton, Florida, 33486, United States
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Daytona Beach, Florida, 32114, United States
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Fort Lauderdale, Florida, 33308, United States
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Fort Myers, Florida, 33901, United States
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Gainesville, Florida, 32610, United States
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Hialeah, Florida, 33016, United States
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Jacksonville, Florida, 32207, United States
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Lakeland, Florida, 33805, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33136, United States
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Miami Beach, Florida, 33140, United States
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Ocala, Florida, 34474, United States
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Ocoee, Florida, 34761, United States
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Orlando, Florida, 32806, United States
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Ormond Beach, Florida, 32174, United States
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Panama City, Florida, 32405, United States
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Pensacola, Florida, 32501, United States
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Pensacola, Florida, 32514, United States
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St. Petersburg, Florida, 33705, United States
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Stuart, Florida, 34994, United States
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Tampa, Florida, 33607, United States
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Weston, Florida, 33331, United States
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Albany, Georgia, 31701, United States
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Atlanta, Georgia, 30309, United States
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Atlanta, Georgia, 30342, United States
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Augusta, Georgia, 30901, United States
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Columbus, Georgia, 31904, United States
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Macon, Georgia, 31201, United States
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Tamc, Hawaii, 96859, United States
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Coeur d'Alene, Idaho, 83814, United States
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Chicago, Illinois, 60637, United States
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Chicago, Illinois, 60640, United States
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Decatur, Illinois, 62526, United States
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Harvey, Illinois, 60426, United States
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Joliet, Illinois, 60432, United States
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Joliet, Illinois, 60435, United States
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Niles, Illinois, 60714, United States
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Peoria, Illinois, 61615, United States
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Springfield, Illinois, 62701, United States
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Urbana, Illinois, 61801, United States
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Beech Grove, Indiana, 46107, United States
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Evansville, Indiana, 47715, United States
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Fishers, Indiana, 46038, United States
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Goshen, Indiana, 46526, United States
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Indianapolis, Indiana, 46254, United States
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Indianapolis, Indiana, 46256, United States
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Kokomo, Indiana, 46902, United States
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La Porte, Indiana, 46350, United States
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South Bend, Indiana, 46601, United States
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Valparaiso, Indiana, 46383, United States
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Ames, Iowa, 50010, United States
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Cedar Rapids, Iowa, 52402, United States
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Cedar Rapids, Iowa, 52403, United States
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Council Bluffs, Iowa, 51503, United States
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Des Moines, Iowa, 50309, United States
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Dubuqe, Iowa, 52001, United States
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Sioux City, Iowa, 51101, United States
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Hutchinson, Kansas, 67502, United States
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Lawrence, Kansas, 66044, United States
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Olathe, Kansas, 66061, United States
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Overland Park, Kansas, 66210, United States
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Wichita, Kansas, 67214, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40207, United States
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Louisville, Kentucky, 40215, United States
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Louisville, Kentucky, 40292, United States
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Baton Rouge, Louisiana, 70809, United States
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Houma, Louisiana, 70360, United States
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Lafayette, Louisiana, 70506, United States
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Metairie, Louisiana, 70006, United States
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Shreveport, Louisiana, 71105, United States
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Bangor, Maine, 4401, United States
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Scarborough, Maine, 04074, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21204, United States
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Baltimore, Maryland, 21237, United States
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Baltimore, Maryland, 21239, United States
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Bethesda, Maryland, 20817, United States
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Chevy Chase, Maryland, 20815, United States
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Clinton, Maryland, 20735, United States
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Rockville, Maryland, 20850, United States
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Boston, Massachusetts, 02215, United States
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Jamaica Plain, Massachusetts, 2130, United States
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Milford, Massachusetts, 01757, United States
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Quincy, Massachusetts, 02169, United States
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Springfield, Massachusetts, 1104, United States
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Springfield, Massachusetts, 1107, United States
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Ann Arbor, Michigan, 48106, United States
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Clinton Township, Michigan, 48038, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Grand Rapids, Michigan, 49546, United States
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Marquette, Michigan, 49855, United States
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Mount Clemens, Michigan, 48043, United States
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Muskegon, Michigan, 49443, United States
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Duluth, Minnesota, 55805, United States
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Minneapolis, Minnesota, 55455, United States
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Saint Louis Park, Minnesota, 55416, United States
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Saint Louis Park, Minnesota, 55426, United States
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Willmar, Minnesota, 56201, United States
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Kansas City, Missouri, 64118, United States
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Saint Joseph, Missouri, 64507, United States
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Springfield, Missouri, 65804, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63136, United States
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St Louis, Missouri, 63141, United States
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Missoula, Montana, 59807, United States
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Lincoln, Nebraska, 68506, United States
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Lincoln, Nebraska, 68510, United States
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North Platte, Nebraska, 69103, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68122, United States
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Omaha, Nebraska, 68124, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89109, United States
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Lebanon, New Hampshire, 03766, United States
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Portsmouth, New Hampshire, 03801, United States
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Belleville, New Jersey, 07109, United States
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East Orange, New Jersey, 7018, United States
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Hackensack, New Jersey, 7601, United States
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Long Branch, New Jersey, 07740, United States
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Montclair, New Jersey, 07042, United States
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Morristown, New Jersey, 07962, United States
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New Brunswick, New Jersey, 08902, United States
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Newark, New Jersey, 07112, United States
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Phillipsburg, New Jersey, 08865, United States
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Summit, New Jersey, 07901, United States
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Albuquerque, New Mexico, 87106, United States
Unknown Facility
Albuquerque, New Mexico, 87108, United States
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Santa Fe, New Mexico, 87505, United States
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Armonk, New York, 10504, United States
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Bay Shore, New York, 11706, United States
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Buffalo, New York, 14263, United States
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Cooperstown, New York, 13326, United States
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Dunkirk, New York, 14048, United States
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East Syracuse, New York, 13057, United States
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Fresh Meadows, New York, 11365, United States
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Glens Falls, New York, 12801, United States
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Jamaica, New York, 11432, United States
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Johnson City, New York, 13790, United States
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Latham, New York, 12110, United States
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Mineola, New York, 11501, United States
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Mount Kisco, New York, 10549, United States
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New York, New York, 10016, United States
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New York, New York, 10021, United States
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New York, New York, 10032, United States
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Poughkeepsie, New York, 12601, United States
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Rochester, New York, 14642, United States
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Setauket, New York, 11733, United States
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Stony Brook, New York, 11794, United States
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The Bronx, New York, 10466, United States
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The Bronx, New York, 10469, United States
Unknown Facility
Utica, New York, 13502, United States
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Williamsville, New York, 14221, United States
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Burlington, North Carolina, 27215, United States
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Chapel Hill, North Carolina, 27599, United States
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Charlotte, North Carolina, 28203, United States
Unknown Facility
Charlotte, North Carolina, 28204, United States
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Greenville, North Carolina, 27834, United States
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Hickory, North Carolina, 28602, United States
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Kinston, North Carolina, 28501, United States
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Pollocksville, North Carolina, 28573, United States
Unknown Facility
Bismarck, North Dakota, 58501, United States
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Fargo, North Dakota, 58108, United States
Unknown Facility
Fargo, North Dakota, 58122, United States
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Barberton, Ohio, 44203, United States
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Canton, Ohio, 44710, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45236, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43213, United States
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Columbus, Ohio, 43214, United States
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Columbus, Ohio, 43235, United States
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Dayton, Ohio, 45429, United States
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Mayfield Heights, Ohio, 44124, United States
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Middletown, Ohio, 45042, United States
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Lawton, Oklahoma, 73505, United States
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Midwest City, Oklahoma, 73110, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74136, United States
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Bend, Oregon, 97701, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97213, United States
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Portland, Oregon, 97239, United States
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Allentown, Pennsylvania, 18105, United States
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Bethlehem, Pennsylvania, 18015, United States
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Dunmore, Pennsylvania, 18512, United States
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East Stroudsburg, Pennsylvania, 18301, United States
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Harrisburg, Pennsylvania, 17111, United States
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Hermitage, Pennsylvania, 16148, United States
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Kittanning, Pennsylvania, 16201, United States
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Lancaster, Pennsylvania, 17604, United States
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Lemoyne, Pennsylvania, 17043, United States
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Monongahela, Pennsylvania, 15063, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19106, United States
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Philadelphia, Pennsylvania, 19111, United States
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Philadelphia, Pennsylvania, 19114, United States
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Pottsville, Pennsylvania, 17901, United States
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State College, Pennsylvania, 16803, United States
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Wynnewood, Pennsylvania, 19096, United States
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York, Pennsylvania, 17403, United States
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Cranston, Rhode Island, 02920, United States
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Charleston, South Carolina, 29403, United States
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Charleston, South Carolina, 29406, United States
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Columbia, South Carolina, 29210, United States
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Florence, South Carolina, 29501, United States
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North Charleston, South Carolina, 29406, United States
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Sioux Falls, South Dakota, 57104, United States
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Clarksville, Tennessee, 37043, United States
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Memphis, Tennessee, 38104, United States
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Memphis, Tennessee, 38119, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Amarillo, Texas, 79106, United States
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Arlington, Texas, 76012, United States
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Austin, Texas, 78705, United States
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Austin, Texas, 78731, United States
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Austin, Texas, 78759, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75237, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77024, United States
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Midland, Texas, 79701, United States
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San Antonio, Texas, 78212, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78245, United States
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Temple, Texas, 76502, United States
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Tyler, Texas, 75701, United States
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Tyler, Texas, 75702, United States
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Ogden, Utah, 84403, United States
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Salt Lake City, Utah, 84112, United States
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Bennington, Vermont, 5201, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Lynchburg, Virginia, 24501, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23229, United States
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Richmond, Virginia, 23230, United States
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Richmond, Virginia, 23235, United States
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Richmond, Virginia, 23294, United States
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Richmond, Virginia, 23298, United States
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Lacey, Washington, 98503, United States
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Seattle, Washington, 98101, United States
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Seattle, Washington, 98104, United States
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Tacoma, Washington, 98405, United States
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Vancouver, Washington, 98684, United States
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Yakima, Washington, 98902, United States
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Charleston, West Virginia, 25304, United States
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Huntington, West Virginia, 25702, United States
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Morgantown, West Virginia, 26505, United States
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Glendale, Wisconsin, 53212, United States
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Green Bay, Wisconsin, 54301, United States
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Madison, Wisconsin, 53715, United States
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Marshfield, Wisconsin, 54449, United States
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Milwaukee, Wisconsin, 53215, United States
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Milwaukee, Wisconsin, 53226, United States
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Wausau, Wisconsin, 54401, United States
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Edmonton, Alberta, T6G 1Z2, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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London, Ontario, N6A 4L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H2W 1S6, Canada
Related Publications (1)
Stadler WM, Figlin RA, McDermott DF, Dutcher JP, Knox JJ, Miller WH Jr, Hainsworth JD, Henderson CA, George JR, Hajdenberg J, Kindwall-Keller TL, Ernstoff MS, Drabkin HA, Curti BD, Chu L, Ryan CW, Hotte SJ, Xia C, Cupit L, Bukowski RM; ARCCS Study Investigators. Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America. Cancer. 2010 Mar 1;116(5):1272-80. doi: 10.1002/cncr.24864.
PMID: 20082451DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 16, 2005
First Posted
May 17, 2005
Study Start
June 1, 2005
Primary Completion
June 1, 2007
Study Completion
October 1, 2008
Last Updated
August 6, 2014
Record last verified: 2014-08