check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

11868

ClinicalTrials.gov Identifier:

NCT00111020

EudraCT Number:

Not Available

EU CT Number:

Not Available
Treatment Protocol for the use of Sorafenib in Patients with Advanced Renal Cell Carcinoma

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

15 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
2567
Trial Dates
June 2005 - October 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Glens Falls, 12801, United States
Completed
Montreal, H2W 1S6, Canada
Completed
Weston, 33331, United States
Completed
New Haven, 6520, United States
Completed
Peoria, 61615, United States
Completed
Marshfield, 54449, United States
Completed
Harrisburg, 17111, United States
Completed
Ogden, 84403, United States
Completed
Baton Rouge, 70809, United States
Completed
Pensacola, 32501, United States
Completed
North Charleston, 29406, United States
Completed
San Antonio, 78229, United States
Completed
Milwaukee, 53226, United States
Completed
Philadelphia, 19114, United States
Completed
Nashville, 37203, United States
Completed
Loma Linda, 92357, United States
Completed
Temple, 76502, United States
Completed
Greenville, 27834, United States
Completed
Seattle, 98101, United States
Completed
Green Bay, 54301, United States
Completed
Baltimore, 21204, United States
Completed
Minneapolis, 55455, United States
Completed
St Louis Park, 55416, United States
Completed
Hackensack, 7601, United States
Completed
Aurora, 80045, United States
Completed
East Orange, 7018, United States
Completed
Chapel Hill, 27599, United States
Completed
Springfield, 1104, United States
Completed
Vallejo, 94589, United States
Completed
Fountain Valley, 92708, United States
Completed
Olathe, 66061, United States
Completed
TAMC, 96859, United States
Completed
Lawton, 73505, United States
Completed
Dallas, 75230, United States
Completed
New Brunswick, 08902, United States
Completed
Fargo, 58122, United States
Completed
Madison, 53715, United States
Completed
Hermitage, 16148, United States
Completed
Chicago, 60637, United States
Completed
Rancho Mirage, 92270, United States
Completed
St Joseph, 64507, United States
Completed
Monongahela, 15063, United States
Completed
Cullman, 35058, United States
Completed
Goshen, 46526, United States
Completed
Canton, 44710, United States
Completed
Midwest City, 73110, United States
Completed
Fargo, 58108, United States
Completed
Utica, 13502, United States
Completed
Arlington, 76012, United States
Completed
Huntington, 25702, United States
Completed
Springfield, 62701, United States
Completed
San Antonio, 78229, United States
Completed
Lakeland, 33805, United States
Completed
Salt Lake City, 84112, United States
Completed
Las Vegas, 89109, United States
Completed
Fort Myers, 33901, United States
Completed
San Antonio, 78212, United States
Completed
Dayton, 45429, United States
Completed
Jamaica, 11432, United States
Completed
Daytona Beach, 32114, United States
Completed
Richmond, 23294, United States
Completed
Chevy Chase, 20815, United States
Completed
Las Vegas, 89106, United States
Completed
St Louis Park, 55426, United States
Completed
Beech Grove, 46107, United States
Completed
Hot Springs, 71913, United States
Completed
Greenwich, 06830, United States
Completed
Charlotte, 28204, United States
Completed
Colorado Springs, 80907, United States
Completed
Missoula, 59807, United States
Completed
Lancaster, 17604, United States
Completed
Springdale, 72764, United States
Completed
MT Clemens, 48043, United States
Completed
Newark, 07112, United States
Completed
Middletown, 45042, United States
Completed
Bakersfield, 93309, United States
Completed
Portsmouth, 03801, United States
Completed
Bismarck, 58501, United States
Completed
Milford, 01757, United States
Completed
Philadelphia, 19111, United States
Completed
Columbus, 43214, United States
Completed
San Diego, 92120, United States
Completed
Los Angeles, 90033, United States
Completed
St Louis, 63110, United States
Completed
Memphis, 38120, United States
Completed
Detroit, 48202, United States
Completed
East Stroudsburg, 18301, United States
Completed
Denver, 80210, United States
Completed
Hutchinson, 67502, United States
Completed
Stony Brook, 11794, United States
Completed
Albuquerque, 87106, United States
Completed
Charleston, 29403, United States
Completed
New York, 10021, United States
Completed
Fort Worth, 76104, United States
Completed
Cedar Rapids, 52402, United States
Completed
Clinton Township, 48038, United States
Completed
Baltimore, 21237, United States
Completed
Marquette, 49855, United States
Completed
Sunnyvale, 94086, United States
Completed
Concord, 94520, United States
Completed
Bronx, 10469, United States
Completed
Lynchburg, 24501, United States
Completed
Columbus, 31904, United States
Completed
Lawrence, 66044, United States
Completed
Charleston, 25304, United States
Completed
Dallas, 75237, United States
Completed
Bend, 97701, United States
Completed
Clinton, 20735, United States
Completed
Lincoln, 68506, United States
Completed
Baltimore, 21239, United States
Completed
Detroit, 48201, United States
Completed
La Jolla, 92093, United States
Completed
Charlottesville, 22908, United States
Completed
Clarksville, 37043, United States
Completed
Poughkeepsie, 12601, United States
Completed
Columbus, 43235, United States
Completed
Columbus, 43213, United States
Completed
New York, 10032, United States
Completed
Pottsville, 17901, United States
Completed
St Louis, 63110, United States
Completed
Houma, 70360, United States
Completed
Setauket, 11733, United States
Completed
Lafayette, 80026, United States
Completed
Dunmore, 18512, United States
Completed
Memphis, 38119, United States
Completed
Armonk, 10504, United States
Completed
Rockville, 20850, United States
Completed
State College, 16803, United States
Completed
Austin, 78705, United States
Completed
York, 17403, United States
Completed
La Jolla, 92037, United States
Completed
Newport Beach, 92663, United States
Completed
Orange, 92868, United States
Completed
Los Angeles, 90025, United States
Completed
Lincoln, 68510, United States
Completed
Pensacola, 32514, United States
Completed
Burlington, 27215, United States
Completed
Urbana, 61801, United States
Completed
Glendale, 53212, United States
Completed
Salinas, 93901, United States
Completed
Cooperstown, 13326, United States
Completed
Williamsville, 14221, United States
Completed
Tyler, 75701, United States
Completed
Mayfield Heights, 44124, United States
Completed
St Petersburg, 33705, United States
Completed
Indianapolis, 46256, United States
Completed
Wausau, 54401, United States
Completed
Tucson, 85704, United States
Completed
Bayshore, 11706, United States
Completed
Albuquerque, 87108, United States
Completed
Rochester, 14642, United States
Completed
Gainesville, 32610, United States
Completed
Albuquerque, 87106, United States
Completed
Boca Raton, 33486, United States
Completed
Bennington, 5201, United States
Completed
Seattle, 98104, United States
Completed
Muskegon, 49443, United States
Completed
Bethlehem, 18015, United States
Completed
St Louis, 63136, United States
Completed
Indianapolis, 46254, United States
Completed
Dubuqe, 52001, United States
Completed
Laporte, 46350, United States
Completed
Duluth, 55805, United States
Completed
Albany, 31701, United States
Completed
Stuart, 34994, United States
Completed
Kinston, 28501, United States
Completed
South Bend, 46601, United States
Completed
Chicago, 60640, United States
Completed
Anchorage, 99508, United States
Completed
Miami, 33136, United States
Completed
Miami Beach, 33140, United States
Completed
Springfield, 65804, United States
Completed
Scottsdale, 85258, United States
Completed
Jamaica Plain, 2130, United States
Completed
New York, 10016, United States
Completed
Bangor, 4401, United States
Completed
Montreal, H2W 1S6, Canada
Completed
Toronto, M5G 2M9, Canada
Completed
London, N6A 4L6, Canada
Completed
Toronto, M4N 3M5, Canada
Completed
Edmonton, T6G 1Z2, Canada
Completed
Hamilton, L8V 5C2, Canada
Completed
Halifax, B3H 2Y9, Canada
Completed
Winnipeg, R3E 0V9, Canada
Completed
Glens Falls, 12801, United States
Completed
Richmond, 23230, United States
Completed
Canton, 44718, United States
Completed
Little Rock, 72205, United States
Completed
Lebanon, 03766, United States
Completed
Hartford, 06105, United States
Completed
Metairie, 70006, United States
Completed
Atlanta, 30309, United States
Completed
Augusta, 30901, United States
Completed
Orlando, 32806, United States
Completed
Glens Falls, 12801, United States
Completed
Beverly, 90211, United States
Completed
Ormond Beach, 32174, United States
Completed
Macon, 31201, United States
Completed
Ocala, 34474, United States
Completed
Latham, 12110, United States
Completed
Wynnewood, 19096, United States
Completed
Pine Bluff, 71603, United States
Completed
Glendale, 85304, United States
Completed
Stamford, 06902, United States
Completed
Mobile, 36608, United States
Completed
Houston, 77024, United States
Completed
Annapolis, 21401, United States
Completed
Louisville, 40292, United States
Completed
Portland, 97213, United States
Completed
Middletown, 06457, United States
Completed
Stanford, 94305, United States
Completed
Bronx, 10466, United States
Completed
Joliet, 60432, United States
Completed
Portland, 97239, United States
Completed
Decatur, 62526, United States
Completed
La Jolla, 92037, United States
Completed
Scarborough, 04074, United States
Completed
Council Bluffs, 51503, United States
Completed
East Syracuse, 13057, United States
Completed
Fresh Meadows, 11365, United States
Completed
Loveland, 80538, United States
Completed
Duarte, 91010, United States
Completed
Springfield, 1107, United States
Completed
Buffalo, 14263, United States
Completed
Dallas, 75246, United States
Completed
Philadelphia, 19106, United States
Completed
Sioux Falls, 57104, United States
Completed
Kokomo, 46902, United States
Completed
Anchorage, 99508, United States
Completed
San Francisco, 94115, United States
Completed
Ocoee, 34761, United States
Completed
Lacey, 98503, United States
Completed
Oklahoma City, 73120, United States
Completed
Tulsa, 74136, United States
Completed
Vancouver, 98684, United States
Completed
Panama City, 32405, United States
Completed
Richmond, 23229, United States
Completed
Evansville, 47715, United States
Completed
Louisville, 40207, United States
Completed
Cedar Rapids, 52403, United States
Completed
Hialeah, 33016, United States
Completed
Valparaiso, 46383, United States
Completed
Coeur D Alene, 83814, United States
Completed
Johnson City, 13790, United States
Completed
Bismarck, 58501, United States
Completed
Morgantown, 26505, United States
Completed
Ames, 50010, United States
Completed
Boston, 02215, United States
Completed
Tacoma, 98405, United States
Completed
St Louis, 63141, United States
Completed
Norfolk, 23502, United States
Completed
Niles, 60714, United States
Completed
Louisville, 40215, United States
Completed
Austin, 78731, United States
Completed
Glendale, 91206, United States
Completed
Pollocksville, 28573, United States
Completed
Mount Kisco, 10549, United States
Completed
Austin, 78759, United States
Completed
Grand Rapids, 49546, United States
Completed
Lemoyne, 17043, United States
Completed
Fishers, 46038, United States
Completed
Amarillo, 79106, United States
Completed
Southington, 06489, United States
Completed
Lafayette, 70506, United States
Completed
Wichita, 67214, United States
Completed
Harvey, 60426, United States
Completed
Tampa, 33607, United States
Completed
Milwaukee, 53215, United States
Completed
Medford, 97504, United States
Completed
Sioux City, 51101, United States
Completed
Charleston, 29406, United States
Completed
Willmar, 56201, United States
Completed
Atlanta, 30342, United States
Completed
Ft Lauderdale, 33308, United States
Completed
Florence, 29501, United States
Completed
New Britain, 06050, United States
Completed
Fairfax, 22031, United States
Completed
Santa Fe, 87505, United States
Completed
Midland, 79701, United States
Completed
Cincinnati, 45236, United States
Completed
Richmond, 23235, United States
Completed
Phillipsburg, 08865, United States
Completed
Los Angeles, 90057, United States
Completed
Joliet, 60435, United States
Completed
Atlanta, 30342, United States
Completed
Long Branch, 07740, United States
Completed
Barberton, 44203, United States
Completed
Hickory, 28602, United States
Completed
Mineola, 11501, United States
Completed
Des Moines, 50309, United States
Completed
St Louis, 63141, United States
Completed
Jacksonville, 32207, United States
Completed
Denver, 80218, United States
Completed
Long Beach, 90813, United States
Completed
Ann Arbor, 48106, United States
Completed
Melbourne, 32901, United States
Completed
Sacramento, 95823, United States
Completed
Dunkirk, 14048, United States
Completed
Columbia, 29210, United States
Completed
Omaha, 68122, United States
Completed
Highland, 92346, United States
Completed
Bessemer, 35023, United States
Completed
Charlotte, 28203, United States
Completed
Overland Park, 66210, United States
Completed
Louisville, 40202, United States
Completed
Summit, 07901, United States
Completed
Shreveport, 71105, United States
Completed
Memphis, 38104, United States
Completed
Omaha, 68114, United States
Completed
Morristown, 07962, United States
Completed
Belleville, 07109, United States
Completed
Quincy, 02169, United States
Completed
Tyler, 75702, United States
Completed
Philadelphia, 19104, United States
Completed
Atlanta, 30342, United States
Completed
Glenwood Springs, 81601, United States
Completed
Conway, 72034, United States
Completed
Richmond, 23298, United States
Completed
Kittanning, 16201, United States
Completed
Montclair, 07042, United States
Completed
San Antonio, 78245, United States
Completed
Norwich, 06360, United States
Completed
Bethesda, 20817, United States
Completed
Cleveland, 44195, United States
Completed
Los Angeles, 90095, United States
Completed
Trumbull, 06611, United States
Completed
New York, 10021, United States
Completed
Cranston, 02920, United States
Completed
North Platte, 69103, United States
Completed
Kansas City, 64118, United States
Completed
Omaha, 68124, United States
Completed
Allentown, 18105, United States
Completed
Yakima, 98902, United States

Primary Outcome

  • Safety parameters
    date_rangeTime Frame:
    From signing consent to 30 days after last dose of study drug
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Limited radiological evaluations
    date_rangeTime Frame:
    At baseline, than every 8 weeks after start of sorafenib
    enhanced_encryption
    Safety Issue:
    No

Trial design

Open Label, Non-Comparative Treatment Protocol for the use of Sorafenib in Patients with Advanced Renal Cell Carcinoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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