Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
NCT ID: NCT00111020
Last Updated: 2014-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2567 participants
INTERVENTIONAL
2005-06-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Sorafenib (Nexavar, BAY43-9006)
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
Interventions
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Sorafenib (Nexavar, BAY43-9006)
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
15 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Bessemer, Alabama, United States
Cullman, Alabama, United States
Mobile, Alabama, United States
Anchorage, Alaska, United States
Glendale, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Conway, Arkansas, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Pine Bluff, Arkansas, United States
Springdale, Arkansas, United States
Bakersfield, California, United States
Beverly, California, United States
Concord, California, United States
Duarte, California, United States
Fountain Valley, California, United States
Glendale, California, United States
Highland, California, United States
La Jolla, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Orange, California, United States
Rancho Mirage, California, United States
Sacramento, California, United States
Salinas, California, United States
San Diego, California, United States
San Francisco, California, United States
Stanford, California, United States
Sunnyvale, California, United States
Vallejo, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Glenwood Springs, Colorado, United States
Lafayette, Colorado, United States
Loveland, Colorado, United States
Greenwich, Connecticut, United States
Hartford, Connecticut, United States
Middletown, Connecticut, United States
New Britain, Connecticut, United States
New Haven, Connecticut, United States
Norwich, Connecticut, United States
Southington, Connecticut, United States
Stamford, Connecticut, United States
Trumbull, Connecticut, United States
Boca Raton, Florida, United States
Daytona Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
Ocala, Florida, United States
Ocoee, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Panama City, Florida, United States
Pensacola, Florida, United States
Pensacola, Florida, United States
St. Petersburg, Florida, United States
Stuart, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
Albany, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Columbus, Georgia, United States
Macon, Georgia, United States
Tamc, Hawaii, United States
Coeur d'Alene, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Harvey, Illinois, United States
Joliet, Illinois, United States
Joliet, Illinois, United States
Niles, Illinois, United States
Peoria, Illinois, United States
Springfield, Illinois, United States
Urbana, Illinois, United States
Beech Grove, Indiana, United States
Evansville, Indiana, United States
Fishers, Indiana, United States
Goshen, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Kokomo, Indiana, United States
La Porte, Indiana, United States
South Bend, Indiana, United States
Valparaiso, Indiana, United States
Ames, Iowa, United States
Cedar Rapids, Iowa, United States
Cedar Rapids, Iowa, United States
Council Bluffs, Iowa, United States
Des Moines, Iowa, United States
Dubuqe, Iowa, United States
Sioux City, Iowa, United States
Hutchinson, Kansas, United States
Lawrence, Kansas, United States
Olathe, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Houma, Louisiana, United States
Lafayette, Louisiana, United States
Metairie, Louisiana, United States
Shreveport, Louisiana, United States
Bangor, Maine, United States
Scarborough, Maine, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Chevy Chase, Maryland, United States
Clinton, Maryland, United States
Rockville, Maryland, United States
Boston, Massachusetts, United States
Jamaica Plain, Massachusetts, United States
Milford, Massachusetts, United States
Quincy, Massachusetts, United States
Springfield, Massachusetts, United States
Springfield, Massachusetts, United States
Ann Arbor, Michigan, United States
Clinton Township, Michigan, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Marquette, Michigan, United States
Mount Clemens, Michigan, United States
Muskegon, Michigan, United States
Duluth, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Louis Park, Minnesota, United States
Saint Louis Park, Minnesota, United States
Willmar, Minnesota, United States
Kansas City, Missouri, United States
Saint Joseph, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Lincoln, Nebraska, United States
Lincoln, Nebraska, United States
North Platte, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
Portsmouth, New Hampshire, United States
Belleville, New Jersey, United States
East Orange, New Jersey, United States
Hackensack, New Jersey, United States
Long Branch, New Jersey, United States
Montclair, New Jersey, United States
Morristown, New Jersey, United States
New Brunswick, New Jersey, United States
Newark, New Jersey, United States
Phillipsburg, New Jersey, United States
Summit, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
Armonk, New York, United States
Bay Shore, New York, United States
Buffalo, New York, United States
Cooperstown, New York, United States
Dunkirk, New York, United States
East Syracuse, New York, United States
Fresh Meadows, New York, United States
Glens Falls, New York, United States
Jamaica, New York, United States
Johnson City, New York, United States
Latham, New York, United States
Mineola, New York, United States
Mount Kisco, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Setauket, New York, United States
Stony Brook, New York, United States
The Bronx, New York, United States
The Bronx, New York, United States
Utica, New York, United States
Williamsville, New York, United States
Burlington, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Hickory, North Carolina, United States
Kinston, North Carolina, United States
Pollocksville, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
Barberton, Ohio, United States
Canton, Ohio, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Mayfield Heights, Ohio, United States
Middletown, Ohio, United States
Lawton, Oklahoma, United States
Midwest City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Bend, Oregon, United States
Medford, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Dunmore, Pennsylvania, United States
East Stroudsburg, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Hermitage, Pennsylvania, United States
Kittanning, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Lemoyne, Pennsylvania, United States
Monongahela, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pottsville, Pennsylvania, United States
State College, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
York, Pennsylvania, United States
Cranston, Rhode Island, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Florence, South Carolina, United States
North Charleston, South Carolina, United States
Sioux Falls, South Dakota, United States
Clarksville, Tennessee, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Arlington, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Midland, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Tyler, Texas, United States
Tyler, Texas, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Bennington, Vermont, United States
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Lynchburg, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Lacey, Washington, United States
Seattle, Washington, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Vancouver, Washington, United States
Yakima, Washington, United States
Charleston, West Virginia, United States
Huntington, West Virginia, United States
Morgantown, West Virginia, United States
Glendale, Wisconsin, United States
Green Bay, Wisconsin, United States
Madison, Wisconsin, United States
Marshfield, Wisconsin, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States
Wausau, Wisconsin, United States
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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11868
Identifier Type: -
Identifier Source: org_study_id
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