Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00111020
First received: May 16, 2005
Last updated: June 29, 2009
Last verified: June 2009
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Purpose
This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY 43-9006, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111020
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| United States, Alabama | |
| Bessemer, Alabama, United States, 35023 | |
| Cullman, Alabama, United States, 35058 | |
| Mobile, Alabama, United States, 36608 | |
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| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Glendale, Arizona, United States, 85304 | |
| Scottsdale, Arizona, United States, 85258 | |
| Tucson, Arizona, United States, 85704 | |
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| 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 | |
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| 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, 90033 | |
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| Los Angeles, California, United States, 90095 | |
| Los Angeles, California, United States, 90025 | |
| 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 | |
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| 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 | |
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| 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 | |
| Naples, Florida, United States, 34102 | |
| 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 | |
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| Albany, Georgia, United States, 31701 | |
| Atlanta, Georgia, United States, 30309 | |
| Atlanta, Georgia, United States, 30342 | |
| Augusta, Georgia, United States, 30901 | |
| Columbus, Georgia, United States, 31904 | |
| Macon, Georgia, United States, 31201 | |
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| Tamc, Hawaii, United States, 96859 | |
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| Coeur D Alene, Idaho, United States, 83814 | |
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| Chicago, Illinois, United States, 60640 | |
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| 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 | |
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| 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, 46256 | |
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| Laporte, Indiana, United States, 46350 | |
| South Bend, Indiana, United States, 46601 | |
| Valparaiso, Indiana, United States, 46383 | |
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| Ames, Iowa, United States, 50010 | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Cedar Rapids, Iowa, United States, 52402 | |
| 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, 40207 | |
| Louisville, Kentucky, United States, 40215 | |
| Louisville, Kentucky, United States, 40202 | |
| 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, 21204 | |
| Baltimore, Maryland, United States, 21237 | |
| Baltimore, Maryland, United States, 21239 | |
| 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, 63110 | |
| St Louis, Missouri, United States, 63141 | |
| St Louis, Missouri, United States, 63136 | |
| United States, Montana | |
| Missoula, Montana, United States, 59807 | |
| United States, Nebraska | |
| Lincoln, Nebraska, United States, 68506 | |
| Lincoln, Nebraska, United States, 68510 | |
| 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 | |
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| 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, 10016 | |
| New York, New York, United States, 10032 | |
| New York, New York, United States, 10021 | |
| 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 | |
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| Burlington, North Carolina, United States, 27215 | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Charlotte, North Carolina, United States, 28204 | |
| Charlotte, North Carolina, United States, 28203 | |
| Greenville, North Carolina, United States, 27834 | |
| Hickory, North Carolina, United States, 28602 | |
| Kinston, North Carolina, United States, 28501 | |
| Pollocksville, North Carolina, United States, 28573 | |
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| 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, 44718 | |
| Canton, Ohio, United States, 44710 | |
| 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, 19106 | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Philadelphia, Pennsylvania, United States, 19114 | |
| 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, 38120 | |
| Memphis, Tennessee, United States, 38104 | |
| Memphis, Tennessee, United States, 38119 | |
| 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, 78705 | |
| Austin, Texas, United States, 78731 | |
| Dallas, Texas, United States, 75246 | |
| Dallas, Texas, United States, 75237 | |
| Dallas, Texas, United States, 75230 | |
| El Paso, Texas, United States, 79902 | |
| Fort Worth, Texas, United States, 76104 | |
| Houston, Texas, United States, 77024 | |
| Midland, Texas, United States, 79701 | |
| San Antonio, Texas, United States, 78212 | |
| San Antonio, Texas, United States, 78229 | |
| San Antonio, Texas, United States, 78245 | |
| 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, 23229 | |
| Richmond, Virginia, United States, 23298 | |
| Richmond, Virginia, United States, 23294 | |
| Richmond, Virginia, United States, 23235 | |
| Richmond, Virginia, United States, 23230 | |
| 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 HealthCare Pharmaceuticals Inc., Therapeutic Area Head |
| ClinicalTrials.gov Identifier: | NCT00111020 History of Changes |
| Other Study ID Numbers: | 11868 |
| Study First Received: | May 16, 2005 |
| Last Updated: | June 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013