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Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00111020
First received: May 16, 2005
Last updated: August 5, 2014
Last verified: August 2014
  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.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, BAY43-9006)
Phase 3

Bayer has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety parameters [ Time Frame: From signing consent to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Limited radiological evaluations [ Time Frame: At baseline, than every 8 weeks after start of sorafenib ] [ Designated as safety issue: No ]

Enrollment: 2567
Study Start Date: June 2005
Study Completion Date: October 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: 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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111020

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

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00111020     History of Changes
Other Study ID Numbers: 11868
Study First Received: May 16, 2005
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014