Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00111020
Collaborator
(none)
2,567
320
1
40
8
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2567 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date
:
Jun 1, 2005
Actual Primary Completion Date
:
Jun 1, 2007
Actual Study Completion Date
:
Oct 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Safety parameters [From signing consent to 30 days after last dose of study drug]
Secondary Outcome Measures
- Limited radiological evaluations [At baseline, than every 8 weeks after start of sorafenib]
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bessemer | Alabama | United States | 35023 | |
| 2 | Cullman | Alabama | United States | 35058 | |
| 3 | Mobile | Alabama | United States | 36608 | |
| 4 | Anchorage | Alaska | United States | 99508 | |
| 5 | Glendale | Arizona | United States | 85304 | |
| 6 | Scottsdale | Arizona | United States | 85258 | |
| 7 | Tucson | Arizona | United States | 85704 | |
| 8 | Conway | Arkansas | United States | 72034 | |
| 9 | Hot Springs | Arkansas | United States | 71913 | |
| 10 | Little Rock | Arkansas | United States | 72205 | |
| 11 | Pine Bluff | Arkansas | United States | 71603 | |
| 12 | Springdale | Arkansas | United States | 72764 | |
| 13 | Bakersfield | California | United States | 93309 | |
| 14 | Beverly | California | United States | 90211 | |
| 15 | Concord | California | United States | 94520 | |
| 16 | Duarte | California | United States | 91010 | |
| 17 | Fountain Valley | California | United States | 92708 | |
| 18 | Glendale | California | United States | 91206 | |
| 19 | Highland | California | United States | 92346 | |
| 20 | La Jolla | California | United States | 92037 | |
| 21 | La Jolla | California | United States | 92093 | |
| 22 | Loma Linda | California | United States | 92357 | |
| 23 | Long Beach | California | United States | 90813 | |
| 24 | Los Angeles | California | United States | 90025 | |
| 25 | Los Angeles | California | United States | 90033 | |
| 26 | Los Angeles | California | United States | 90057 | |
| 27 | Los Angeles | California | United States | 90095 | |
| 28 | Newport Beach | California | United States | 92663 | |
| 29 | Orange | California | United States | 92868 | |
| 30 | Rancho Mirage | California | United States | 92270 | |
| 31 | Sacramento | California | United States | 95823 | |
| 32 | Salinas | California | United States | 93901 | |
| 33 | San Diego | California | United States | 92120 | |
| 34 | San Francisco | California | United States | 94115 | |
| 35 | Stanford | California | United States | 94305 | |
| 36 | Sunnyvale | California | United States | 94086 | |
| 37 | Vallejo | California | United States | 94589 | |
| 38 | Aurora | Colorado | United States | 80045 | |
| 39 | Colorado Springs | Colorado | United States | 80907 | |
| 40 | Denver | Colorado | United States | 80210 | |
| 41 | Denver | Colorado | United States | 80218 | |
| 42 | Glenwood Springs | Colorado | United States | 81601 | |
| 43 | Lafayette | Colorado | United States | 80026 | |
| 44 | Loveland | Colorado | United States | 80538 | |
| 45 | Greenwich | Connecticut | United States | 06830 | |
| 46 | Hartford | Connecticut | United States | 06105 | |
| 47 | Middletown | Connecticut | United States | 06457 | |
| 48 | New Britain | Connecticut | United States | 06050 | |
| 49 | New Haven | Connecticut | United States | 6520 | |
| 50 | Norwich | Connecticut | United States | 06360 | |
| 51 | Southington | Connecticut | United States | 06489 | |
| 52 | Stamford | Connecticut | United States | 06902 | |
| 53 | Trumbull | Connecticut | United States | 06611 | |
| 54 | Boca Raton | Florida | United States | 33486 | |
| 55 | Daytona Beach | Florida | United States | 32114 | |
| 56 | Fort Myers | Florida | United States | 33901 | |
| 57 | Ft Lauderdale | Florida | United States | 33308 | |
| 58 | Gainesville | Florida | United States | 32610 | |
| 59 | Hialeah | Florida | United States | 33016 | |
| 60 | Jacksonville | Florida | United States | 32207 | |
| 61 | Lakeland | Florida | United States | 33805 | |
| 62 | Melbourne | Florida | United States | 32901 | |
| 63 | Miami Beach | Florida | United States | 33140 | |
| 64 | Miami | Florida | United States | 33136 | |
| 65 | Ocala | Florida | United States | 34474 | |
| 66 | Ocoee | Florida | United States | 34761 | |
| 67 | Orlando | Florida | United States | 32806 | |
| 68 | Ormond Beach | Florida | United States | 32174 | |
| 69 | Panama City | Florida | United States | 32405 | |
| 70 | Pensacola | Florida | United States | 32501 | |
| 71 | Pensacola | Florida | United States | 32514 | |
| 72 | St Petersburg | Florida | United States | 33705 | |
| 73 | Stuart | Florida | United States | 34994 | |
| 74 | Tampa | Florida | United States | 33607 | |
| 75 | Weston | Florida | United States | 33331 | |
| 76 | Albany | Georgia | United States | 31701 | |
| 77 | Atlanta | Georgia | United States | 30309 | |
| 78 | Atlanta | Georgia | United States | 30342 | |
| 79 | Augusta | Georgia | United States | 30901 | |
| 80 | Columbus | Georgia | United States | 31904 | |
| 81 | Macon | Georgia | United States | 31201 | |
| 82 | Tamc | Hawaii | United States | 96859 | |
| 83 | Coeur D Alene | Idaho | United States | 83814 | |
| 84 | Chicago | Illinois | United States | 60637 | |
| 85 | Chicago | Illinois | United States | 60640 | |
| 86 | Decatur | Illinois | United States | 62526 | |
| 87 | Harvey | Illinois | United States | 60426 | |
| 88 | Joliet | Illinois | United States | 60432 | |
| 89 | Joliet | Illinois | United States | 60435 | |
| 90 | Niles | Illinois | United States | 60714 | |
| 91 | Peoria | Illinois | United States | 61615 | |
| 92 | Springfield | Illinois | United States | 62701 | |
| 93 | Urbana | Illinois | United States | 61801 | |
| 94 | Beech Grove | Indiana | United States | 46107 | |
| 95 | Evansville | Indiana | United States | 47715 | |
| 96 | Fishers | Indiana | United States | 46038 | |
| 97 | Goshen | Indiana | United States | 46526 | |
| 98 | Indianapolis | Indiana | United States | 46254 | |
| 99 | Indianapolis | Indiana | United States | 46256 | |
| 100 | Kokomo | Indiana | United States | 46902 | |
| 101 | Laporte | Indiana | United States | 46350 | |
| 102 | South Bend | Indiana | United States | 46601 | |
| 103 | Valparaiso | Indiana | United States | 46383 | |
| 104 | Ames | Iowa | United States | 50010 | |
| 105 | Cedar Rapids | Iowa | United States | 52402 | |
| 106 | Cedar Rapids | Iowa | United States | 52403 | |
| 107 | Council Bluffs | Iowa | United States | 51503 | |
| 108 | Des Moines | Iowa | United States | 50309 | |
| 109 | Dubuqe | Iowa | United States | 52001 | |
| 110 | Sioux City | Iowa | United States | 51101 | |
| 111 | Hutchinson | Kansas | United States | 67502 | |
| 112 | Lawrence | Kansas | United States | 66044 | |
| 113 | Olathe | Kansas | United States | 66061 | |
| 114 | Overland Park | Kansas | United States | 66210 | |
| 115 | Wichita | Kansas | United States | 67214 | |
| 116 | Louisville | Kentucky | United States | 40202 | |
| 117 | Louisville | Kentucky | United States | 40207 | |
| 118 | Louisville | Kentucky | United States | 40215 | |
| 119 | Louisville | Kentucky | United States | 40292 | |
| 120 | Baton Rouge | Louisiana | United States | 70809 | |
| 121 | Houma | Louisiana | United States | 70360 | |
| 122 | Lafayette | Louisiana | United States | 70506 | |
| 123 | Metairie | Louisiana | United States | 70006 | |
| 124 | Shreveport | Louisiana | United States | 71105 | |
| 125 | Bangor | Maine | United States | 4401 | |
| 126 | Scarborough | Maine | United States | 04074 | |
| 127 | Annapolis | Maryland | United States | 21401 | |
| 128 | Baltimore | Maryland | United States | 21204 | |
| 129 | Baltimore | Maryland | United States | 21237 | |
| 130 | Baltimore | Maryland | United States | 21239 | |
| 131 | Bethesda | Maryland | United States | 20817 | |
| 132 | Chevy Chase | Maryland | United States | 20815 | |
| 133 | Clinton | Maryland | United States | 20735 | |
| 134 | Rockville | Maryland | United States | 20850 | |
| 135 | Boston | Massachusetts | United States | 02215 | |
| 136 | Jamaica Plain | Massachusetts | United States | 2130 | |
| 137 | Milford | Massachusetts | United States | 01757 | |
| 138 | Quincy | Massachusetts | United States | 02169 | |
| 139 | Springfield | Massachusetts | United States | 1104 | |
| 140 | Springfield | Massachusetts | United States | 1107 | |
| 141 | Ann Arbor | Michigan | United States | 48106 | |
| 142 | Clinton Township | Michigan | United States | 48038 | |
| 143 | Detroit | Michigan | United States | 48201 | |
| 144 | Detroit | Michigan | United States | 48202 | |
| 145 | Grand Rapids | Michigan | United States | 49546 | |
| 146 | Marquette | Michigan | United States | 49855 | |
| 147 | MT Clemens | Michigan | United States | 48043 | |
| 148 | Muskegon | Michigan | United States | 49443 | |
| 149 | Duluth | Minnesota | United States | 55805 | |
| 150 | Minneapolis | Minnesota | United States | 55455 | |
| 151 | St Louis Park | Minnesota | United States | 55416 | |
| 152 | St Louis Park | Minnesota | United States | 55426 | |
| 153 | Willmar | Minnesota | United States | 56201 | |
| 154 | Kansas City | Missouri | United States | 64118 | |
| 155 | Springfield | Missouri | United States | 65804 | |
| 156 | St Joseph | Missouri | United States | 64507 | |
| 157 | St Louis | Missouri | United States | 63110 | |
| 158 | St Louis | Missouri | United States | 63136 | |
| 159 | St Louis | Missouri | United States | 63141 | |
| 160 | Missoula | Montana | United States | 59807 | |
| 161 | Lincoln | Nebraska | United States | 68506 | |
| 162 | Lincoln | Nebraska | United States | 68510 | |
| 163 | North Platte | Nebraska | United States | 69103 | |
| 164 | Omaha | Nebraska | United States | 68114 | |
| 165 | Omaha | Nebraska | United States | 68122 | |
| 166 | Omaha | Nebraska | United States | 68124 | |
| 167 | Las Vegas | Nevada | United States | 89106 | |
| 168 | Las Vegas | Nevada | United States | 89109 | |
| 169 | Lebanon | New Hampshire | United States | 03766 | |
| 170 | Portsmouth | New Hampshire | United States | 03801 | |
| 171 | Belleville | New Jersey | United States | 07109 | |
| 172 | East Orange | New Jersey | United States | 7018 | |
| 173 | Hackensack | New Jersey | United States | 7601 | |
| 174 | Long Branch | New Jersey | United States | 07740 | |
| 175 | Montclair | New Jersey | United States | 07042 | |
| 176 | Morristown | New Jersey | United States | 07962 | |
| 177 | New Brunswick | New Jersey | United States | 08902 | |
| 178 | Newark | New Jersey | United States | 07112 | |
| 179 | Phillipsburg | New Jersey | United States | 08865 | |
| 180 | Summit | New Jersey | United States | 07901 | |
| 181 | Albuquerque | New Mexico | United States | 87106 | |
| 182 | Albuquerque | New Mexico | United States | 87108 | |
| 183 | Santa Fe | New Mexico | United States | 87505 | |
| 184 | Armonk | New York | United States | 10504 | |
| 185 | Bayshore | New York | United States | 11706 | |
| 186 | Bronx | New York | United States | 10466 | |
| 187 | Bronx | New York | United States | 10469 | |
| 188 | Buffalo | New York | United States | 14263 | |
| 189 | Cooperstown | New York | United States | 13326 | |
| 190 | Dunkirk | New York | United States | 14048 | |
| 191 | East Syracuse | New York | United States | 13057 | |
| 192 | Fresh Meadows | New York | United States | 11365 | |
| 193 | Glens Falls | New York | United States | 12801 | |
| 194 | Jamaica | New York | United States | 11432 | |
| 195 | Johnson City | New York | United States | 13790 | |
| 196 | Latham | New York | United States | 12110 | |
| 197 | Mineola | New York | United States | 11501 | |
| 198 | Mount Kisco | New York | United States | 10549 | |
| 199 | New York | New York | United States | 10016 | |
| 200 | New York | New York | United States | 10021 | |
| 201 | New York | New York | United States | 10032 | |
| 202 | Poughkeepsie | New York | United States | 12601 | |
| 203 | Rochester | New York | United States | 14642 | |
| 204 | Setauket | New York | United States | 11733 | |
| 205 | Stony Brook | New York | United States | 11794 | |
| 206 | Utica | New York | United States | 13502 | |
| 207 | Williamsville | New York | United States | 14221 | |
| 208 | Burlington | North Carolina | United States | 27215 | |
| 209 | Chapel Hill | North Carolina | United States | 27599 | |
| 210 | Charlotte | North Carolina | United States | 28203 | |
| 211 | Charlotte | North Carolina | United States | 28204 | |
| 212 | Greenville | North Carolina | United States | 27834 | |
| 213 | Hickory | North Carolina | United States | 28602 | |
| 214 | Kinston | North Carolina | United States | 28501 | |
| 215 | Pollocksville | North Carolina | United States | 28573 | |
| 216 | Bismarck | North Dakota | United States | 58501 | |
| 217 | Fargo | North Dakota | United States | 58108 | |
| 218 | Fargo | North Dakota | United States | 58122 | |
| 219 | Barberton | Ohio | United States | 44203 | |
| 220 | Canton | Ohio | United States | 44710 | |
| 221 | Canton | Ohio | United States | 44718 | |
| 222 | Cincinnati | Ohio | United States | 45236 | |
| 223 | Cleveland | Ohio | United States | 44195 | |
| 224 | Columbus | Ohio | United States | 43213 | |
| 225 | Columbus | Ohio | United States | 43214 | |
| 226 | Columbus | Ohio | United States | 43235 | |
| 227 | Dayton | Ohio | United States | 45429 | |
| 228 | Mayfield Heights | Ohio | United States | 44124 | |
| 229 | Middletown | Ohio | United States | 45042 | |
| 230 | Lawton | Oklahoma | United States | 73505 | |
| 231 | Midwest City | Oklahoma | United States | 73110 | |
| 232 | Oklahoma City | Oklahoma | United States | 73120 | |
| 233 | Tulsa | Oklahoma | United States | 74136 | |
| 234 | Bend | Oregon | United States | 97701 | |
| 235 | Medford | Oregon | United States | 97504 | |
| 236 | Portland | Oregon | United States | 97213 | |
| 237 | Portland | Oregon | United States | 97239 | |
| 238 | Allentown | Pennsylvania | United States | 18105 | |
| 239 | Bethlehem | Pennsylvania | United States | 18015 | |
| 240 | Dunmore | Pennsylvania | United States | 18512 | |
| 241 | East Stroudsburg | Pennsylvania | United States | 18301 | |
| 242 | Harrisburg | Pennsylvania | United States | 17111 | |
| 243 | Hermitage | Pennsylvania | United States | 16148 | |
| 244 | Kittanning | Pennsylvania | United States | 16201 | |
| 245 | Lancaster | Pennsylvania | United States | 17604 | |
| 246 | Lemoyne | Pennsylvania | United States | 17043 | |
| 247 | Monongahela | Pennsylvania | United States | 15063 | |
| 248 | Philadelphia | Pennsylvania | United States | 19104 | |
| 249 | Philadelphia | Pennsylvania | United States | 19106 | |
| 250 | Philadelphia | Pennsylvania | United States | 19111 | |
| 251 | Philadelphia | Pennsylvania | United States | 19114 | |
| 252 | Pottsville | Pennsylvania | United States | 17901 | |
| 253 | State College | Pennsylvania | United States | 16803 | |
| 254 | Wynnewood | Pennsylvania | United States | 19096 | |
| 255 | York | Pennsylvania | United States | 17403 | |
| 256 | Cranston | Rhode Island | United States | 02920 | |
| 257 | Charleston | South Carolina | United States | 29403 | |
| 258 | Charleston | South Carolina | United States | 29406 | |
| 259 | Columbia | South Carolina | United States | 29210 | |
| 260 | Florence | South Carolina | United States | 29501 | |
| 261 | North Charleston | South Carolina | United States | 29406 | |
| 262 | Sioux Falls | South Dakota | United States | 57104 | |
| 263 | Clarksville | Tennessee | United States | 37043 | |
| 264 | Memphis | Tennessee | United States | 38104 | |
| 265 | Memphis | Tennessee | United States | 38119 | |
| 266 | Memphis | Tennessee | United States | 38120 | |
| 267 | Nashville | Tennessee | United States | 37203 | |
| 268 | Amarillo | Texas | United States | 79106 | |
| 269 | Arlington | Texas | United States | 76012 | |
| 270 | Austin | Texas | United States | 78705 | |
| 271 | Austin | Texas | United States | 78731 | |
| 272 | Austin | Texas | United States | 78759 | |
| 273 | Dallas | Texas | United States | 75230 | |
| 274 | Dallas | Texas | United States | 75237 | |
| 275 | Dallas | Texas | United States | 75246 | |
| 276 | Fort Worth | Texas | United States | 76104 | |
| 277 | Houston | Texas | United States | 77024 | |
| 278 | Midland | Texas | United States | 79701 | |
| 279 | San Antonio | Texas | United States | 78212 | |
| 280 | San Antonio | Texas | United States | 78229 | |
| 281 | San Antonio | Texas | United States | 78245 | |
| 282 | Temple | Texas | United States | 76502 | |
| 283 | Tyler | Texas | United States | 75701 | |
| 284 | Tyler | Texas | United States | 75702 | |
| 285 | Ogden | Utah | United States | 84403 | |
| 286 | Salt Lake City | Utah | United States | 84112 | |
| 287 | Bennington | Vermont | United States | 5201 | |
| 288 | Charlottesville | Virginia | United States | 22908 | |
| 289 | Fairfax | Virginia | United States | 22031 | |
| 290 | Lynchburg | Virginia | United States | 24501 | |
| 291 | Norfolk | Virginia | United States | 23502 | |
| 292 | Richmond | Virginia | United States | 23229 | |
| 293 | Richmond | Virginia | United States | 23230 | |
| 294 | Richmond | Virginia | United States | 23235 | |
| 295 | Richmond | Virginia | United States | 23294 | |
| 296 | Richmond | Virginia | United States | 23298 | |
| 297 | Lacey | Washington | United States | 98503 | |
| 298 | Seattle | Washington | United States | 98101 | |
| 299 | Seattle | Washington | United States | 98104 | |
| 300 | Tacoma | Washington | United States | 98405 | |
| 301 | Vancouver | Washington | United States | 98684 | |
| 302 | Yakima | Washington | United States | 98902 | |
| 303 | Charleston | West Virginia | United States | 25304 | |
| 304 | Huntington | West Virginia | United States | 25702 | |
| 305 | Morgantown | West Virginia | United States | 26505 | |
| 306 | Glendale | Wisconsin | United States | 53212 | |
| 307 | Green Bay | Wisconsin | United States | 54301 | |
| 308 | Madison | Wisconsin | United States | 53715 | |
| 309 | Marshfield | Wisconsin | United States | 54449 | |
| 310 | Milwaukee | Wisconsin | United States | 53215 | |
| 311 | Milwaukee | Wisconsin | United States | 53226 | |
| 312 | Wausau | Wisconsin | United States | 54401 | |
| 313 | Edmonton | Alberta | Canada | T6G 1Z2 | |
| 314 | Winnipeg | Manitoba | Canada | R3E 0V9 | |
| 315 | Halifax | Nova Scotia | Canada | B3H 2Y9 | |
| 316 | Hamilton | Ontario | Canada | L8V 5C2 | |
| 317 | London | Ontario | Canada | N6A 4L6 | |
| 318 | Toronto | Ontario | Canada | M4N 3M5 | |
| 319 | Toronto | Ontario | Canada | M5G 2M9 | |
| 320 | Montreal | Quebec | Canada | H2W 1S6 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00111020
Other Study ID Numbers:
- 11868
First Posted:
May 17, 2005
Last Update Posted:
Aug 6, 2014
Last Verified:
Aug 1, 2014