- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00267748
Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
A Randomized Phase II Study Of The Efficacy And Safety Of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (Renal EFFECT Trial)
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment.
The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Arkansas
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Hot Springs, Arkansas, Spojené státy, 71913
- Pfizer Investigational Site
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Little Rock, Arkansas, Spojené státy, 72205
- Pfizer Investigational Site
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California
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Anaheim, California, Spojené státy, 92807
- Pfizer Investigational Site
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Baldwin Park, California, Spojené státy, 91706
- Pfizer Investigational Site
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Bellflower, California, Spojené státy, 90706
- Pfizer Investigational Site
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Duarte, California, Spojené státy, 91010
- Pfizer Investigational Site
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Fontana, California, Spojené státy, 92335
- Pfizer Investigational Site
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Irvine, California, Spojené státy, 92618
- Pfizer Investigational Site
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Los Angeles, California, Spojené státy, 90095
- Pfizer Investigational Site
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Los Angeles, California, Spojené státy, 90027
- Pfizer Investigational Site
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Los Angeles, California, Spojené státy, 90034
- Pfizer Investigational Site
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Panorama City, California, Spojené státy, 91402
- Pfizer Investigational Site
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Riverside, California, Spojené státy, 92505
- Pfizer Investigational Site
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San Diego, California, Spojené státy, 92108
- Pfizer Investigational Site
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San Diego, California, Spojené státy, 92120
- Pfizer Investigational Site
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Woodland Hills, California, Spojené státy, 91365
- Pfizer Investigational Site
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Colorado
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Aurora, Colorado, Spojené státy, 80012
- Pfizer Investigational Site
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Boulder, Colorado, Spojené státy, 80304
- Pfizer Investigational Site
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Boulder, Colorado, Spojené státy, 80303
- Pfizer Investigational Site
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Colorado Springs, Colorado, Spojené státy, 80909
- Pfizer Investigational Site
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Denver, Colorado, Spojené státy, 80220
- Pfizer Investigational Site
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Denver, Colorado, Spojené státy, 80218
- Pfizer Investigational Site
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Lakewood, Colorado, Spojené státy, 80228
- Pfizer Investigational Site
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Littleton, Colorado, Spojené státy, 80120
- Pfizer Investigational Site
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Lone Tree, Colorado, Spojené státy, 80124
- Pfizer Investigational Site
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Longmont, Colorado, Spojené státy, 80501
- Pfizer Investigational Site
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Parker, Colorado, Spojené státy, 80138
- Pfizer Investigational Site
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Pueblo, Colorado, Spojené státy, 81008
- Pfizer Investigational Site
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Thorton, Colorado, Spojené státy, 80260
- Pfizer Investigational Site
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Connecticut
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Norwich, Connecticut, Spojené státy, 06360
- Pfizer Investigational Site
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Delaware
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Newark, Delaware, Spojené státy, 19718
- Pfizer Investigational Site
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Newark, Delaware, Spojené státy, 19713
- Pfizer Investigational Site
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Wilmington, Delaware, Spojené státy, 19899
- Pfizer Investigational Site
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Florida
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Boca Raton, Florida, Spojené státy, 33486
- Pfizer Investigational Site
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Delray Beach, Florida, Spojené státy, 33484
- Pfizer Investigational Site
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Lakeland, Florida, Spojené státy, 33805
- Pfizer Investigational Site
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Orlando, Florida, Spojené státy, 32806
- Pfizer Investigational Site
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Georgia
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Columbus, Georgia, Spojené státy, 31902
- Pfizer Investigational Site
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Columbus, Georgia, Spojené státy, 31904
- Pfizer Investigational Site
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Idaho
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Boise, Idaho, Spojené státy, 83712
- Pfizer Investigational Site
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Indiana
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Elkhart, Indiana, Spojené státy, 46514
- Pfizer Investigational Site
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Jefferson, Indiana, Spojené státy, 47130
- Pfizer Investigational Site
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Kokomo, Indiana, Spojené státy, 46902-3803
- Pfizer Investigational Site
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La Porte, Indiana, Spojené státy, 46350
- Pfizer Investigational Site
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LaPorte, Indiana, Spojené státy, 46350
- Pfizer Investigational Site
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LaPorte, Indiana, Spojené státy, 46350-5533
- Pfizer Investigational Site
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Michigan City, Indiana, Spojené státy, 46360
- Pfizer Investigational Site
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Plymouth, Indiana, Spojené státy, 46563
- Pfizer Investigational Site
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South Bend, Indiana, Spojené státy, 46601
- Pfizer Investigational Site
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South Bend, Indiana, Spojené státy, 46617
- Pfizer Investigational Site
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Iowa
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Cedar Rapids, Iowa, Spojené státy, 52402
- Pfizer Investigational Site
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Kentucky
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Lexington, Kentucky, Spojené státy, 40536
- Pfizer Investigational Site
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Lexington, Kentucky, Spojené státy, 40536-0293
- Pfizer Investigational Site
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Louisville, Kentucky, Spojené státy, 40202
- Pfizer Investigational Site
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Louisville, Kentucky, Spojené státy, 40217
- Pfizer Investigational Site
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Louisville, Kentucky, Spojené státy, 40207
- Pfizer Investigational Site
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Shelbyville, Kentucky, Spojené státy, 40065
- Pfizer Investigational Site
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Louisiana
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Baton Rouge, Louisiana, Spojené státy, 70809
- Pfizer Investigational Site
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Covington, Louisiana, Spojené státy, 70433
- Pfizer Investigational Site
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Gretna, Louisiana, Spojené státy, 70056
- Pfizer Investigational Site
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Marrero, Louisiana, Spojené státy, 70072
- Pfizer Investigational Site
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Metairie, Louisiana, Spojené státy, 70006
- Pfizer Investigational Site
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New Orleans, Louisiana, Spojené státy, 70115
- Pfizer Investigational Site
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Shreveport, Louisiana, Spojené státy, 71103
- Pfizer Investigational Site
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- Pfizer Investigational Site
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Baltimore, Maryland, Spojené státy, 21237
- Pfizer Investigational Site
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Bethesda, Maryland, Spojené státy, 20817
- Pfizer Investigational Site
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Michigan
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Grand Rapids, Michigan, Spojené státy, 49503
- Pfizer Investigational Site
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Holland, Michigan, Spojené státy, 49424
- Pfizer Investigational Site
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Niles, Michigan, Spojené státy, 49120
- Pfizer Investigational Site
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Saint Joseph, Michigan, Spojené státy, 49085
- Pfizer Investigational Site
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St. Joseph, Michigan, Spojené státy, 49085
- Pfizer Investigational Site
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St. Joseph, Michigan, Spojené státy, 49085-2112
- Pfizer Investigational Site
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St. Joseph, Michigan, Spojené státy, 49085-2158
- Pfizer Investigational Site
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Missouri
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Saint Louis, Missouri, Spojené státy, 63141
- Pfizer Investigational Site
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St. Louis, Missouri, Spojené státy, 63141
- Pfizer Investigational Site
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Washington, Missouri, Spojené státy, 63090
- Pfizer Investigational Site
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Nevada
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Henderson, Nevada, Spojené státy, 89052
- Pfizer Investigational Site
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Las Vegas, Nevada, Spojené státy, 89128
- Pfizer Investigational Site
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Las Vegas, Nevada, Spojené státy, 89148
- Pfizer Investigational Site
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Las Vegas, Nevada, Spojené státy, 89135
- Pfizer Investigational Site
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Las Vegas, Nevada, Spojené státy, 89169
- Pfizer Investigational Site
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- Pfizer Investigational Site
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87131-0001
- Pfizer Investigational Site
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Farmington, New Mexico, Spojené státy, 87401-5631
- Pfizer Investigational Site
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New York
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Albany, New York, Spojené státy, 12206
- Pfizer Investigational Site
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Albany, New York, Spojené státy, 12208
- Pfizer Investigational Site
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Amsterdam, New York, Spojené státy, 12010
- Pfizer Investigational Site
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Brockport, New York, Spojené státy, 14420
- Pfizer Investigational Site
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Canadaigua, New York, Spojené státy, 14424
- Pfizer Investigational Site
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Geneva, New York, Spojené státy, 14456
- Pfizer Investigational Site
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Hudson, New York, Spojené státy, 12534
- Pfizer Investigational Site
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Latham, New York, Spojené státy, 12110
- Pfizer Investigational Site
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New York, New York, Spojené státy, 10021
- Pfizer Investigational Site
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New York, New York, Spojené státy, 10032
- Pfizer Investigational Site
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New York, New York, Spojené státy, 10022
- Pfizer Investigational Site
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Rexford, New York, Spojené státy, 12148
- Pfizer Investigational Site
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Rochester, New York, Spojené státy, 14623
- Pfizer Investigational Site
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Rochester, New York, Spojené státy, 14626
- Pfizer Investigational Site
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Troy, New York, Spojené státy, 12180
- Pfizer Investigational Site
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North Carolina
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Cary, North Carolina, Spojené státy, 27518
- Pfizer Investigational Site
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Clinton, North Carolina, Spojené státy, 28328
- Pfizer Investigational Site
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Elizabeth City, North Carolina, Spojené státy, 27909
- Pfizer Investigational Site
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Goldsboro, North Carolina, Spojené státy, 27534
- Pfizer Investigational Site
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Hickory, North Carolina, Spojené státy, 28602
- Pfizer Investigational Site
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Raleigh, North Carolina, Spojené státy, 27607
- Pfizer Investigational Site
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Raleigh, North Carolina, Spojené státy, 27614
- Pfizer Investigational Site
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Wilson, North Carolina, Spojené státy, 27893
- Pfizer Investigational Site
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Ohio
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Canton, Ohio, Spojené státy, 44718
- Pfizer Investigational Site
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Columbus, Ohio, Spojené státy, 43219
- Pfizer Investigational Site
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Oklahoma
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Norman, Oklahoma, Spojené státy, 73071
- Pfizer Investigational Site
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Oklahoma City, Oklahoma, Spojené státy, 73120
- Pfizer Investigational Site
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Oklahoma City, Oklahoma, Spojené státy, 73102
- Pfizer Investigational Site
-
Oklahoma City, Oklahoma, Spojené státy, 73109
- Pfizer Investigational Site
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Oklahoma City, Oklahoma, Spojené státy, 73112-4416
- Pfizer Investigational Site
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Tulsa, Oklahoma, Spojené státy, 74133
- Pfizer Investigational Site
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Tulsa, Oklahoma, Spojené státy, 74104
- Pfizer Investigational Site
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Tulsa, Oklahoma, Spojené státy, 74136-1902
- Pfizer Investigational Site
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Oregon
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Eugene, Oregon, Spojené státy, 97401
- Pfizer Investigational Site
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Springfield, Oregon, Spojené státy, 97477
- Pfizer Investigational Site
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Pennsylvania
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Dunmore, Pennsylvania, Spojené státy, 18512-3169
- Pfizer Investigational Site
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Lemoyne, Pennsylvania, Spojené státy, 17043-1440
- Pfizer Investigational Site
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Philadelphia, Pennsylvania, Spojené státy, 19111-2497
- Pfizer Investigational Site
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Scranton, Pennsylvania, Spojené státy, 18508
- Pfizer Investigational Site
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South Carolina
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Easley, South Carolina, Spojené státy, 29640
- Pfizer Investigational Site
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Greenville, South Carolina, Spojené státy, 29615
- Pfizer Investigational Site
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Greenville, South Carolina, Spojené státy, 29605
- Pfizer Investigational Site
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Seneca, South Carolina, Spojené státy, 29672
- Pfizer Investigational Site
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Spartanburg, South Carolina, Spojené státy, 29307
- Pfizer Investigational Site
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Texas
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Austin, Texas, Spojené státy, 78705
- Pfizer Investigational Site
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Austin, Texas, Spojené státy, 78745
- Pfizer Investigational Site
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Austin, Texas, Spojené státy, 78759
- Pfizer Investigational Site
-
Austin, Texas, Spojené státy, 78731
- Pfizer Investigational Site
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Austin, Texas, Spojené státy, 78758
- Pfizer Investigational Site
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Bedford, Texas, Spojené státy, 76022
- Pfizer Investigational Site
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Corpus Christi, Texas, Spojené státy, 78463
- Pfizer Investigational Site
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Dallas, Texas, Spojené státy, 75230
- Pfizer Investigational Site
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Dallas, Texas, Spojené státy, 75246
- Pfizer Investigational Site
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Fort Worth, Texas, Spojené státy, 76177
- Pfizer Investigational Site
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Georgetown, Texas, Spojené státy, 78626
- Pfizer Investigational Site
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Round Rock, Texas, Spojené státy, 78681
- Pfizer Investigational Site
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San Antonio, Texas, Spojené státy, 78229
- Pfizer Investigational Site
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San Antonio, Texas, Spojené státy, 78207
- Pfizer Investigational Site
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San Antonio, Texas, Spojené státy, 78217
- Pfizer Investigational Site
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San Antonio, Texas, Spojené státy, 78258
- Pfizer Investigational Site
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Tyler, Texas, Spojené státy, 75702
- Pfizer Investigational Site
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Webster, Texas, Spojené státy, 77598
- Pfizer Investigational Site
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Utah
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Salt Lake City, Utah, Spojené státy, 84112
- Pfizer Investigational Site
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Virginia
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Chesapeake, Virginia, Spojené státy, 23320
- Pfizer Investigational Site
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Hampton, Virginia, Spojené státy, 23666
- Pfizer Investigational Site
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Newport News, Virginia, Spojené státy, 23601
- Pfizer Investigational Site
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Newport News, Virginia, Spojené státy, 23502
- Pfizer Investigational Site
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Norfolk, Virginia, Spojené státy, 23502
- Pfizer Investigational Site
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Virginia Beach, Virginia, Spojené státy, 23456
- Pfizer Investigational Site
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Williamsburg, Virginia, Spojené státy, 23188
- Pfizer Investigational Site
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Washington
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Seattle, Washington, Spojené státy, 98195
- Pfizer Investigational Site
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Seattle, Washington, Spojené státy, 98109
- Pfizer Investigational Site
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West Virginia
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Morgantown, West Virginia, Spojené státy, 26506
- Pfizer Investigational Site
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Wisconsin
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Madison, Wisconsin, Spojené státy, 53792
- Pfizer Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
- Measurable disease
Exclusion Criteria:
- Prior systemic therapy of any kind for advanced renal cell cancer
- History of brain metastases
- Uncontrolled hypertension
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: A
|
Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period.
This six week cycle is repeated.
|
|
Experimentální: C
|
Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model
Časové okno: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.
|
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With Objective Response (OR)
Časové okno: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
CR are defined as the disappearance of all lesions (target and/or non target).
PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
|
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
|
Duration of Response (DR)
Časové okno: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause.
Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44.
DR was calculated for the subgroup of participants with a confirmed objective tumor response.
|
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
|
Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model
Časové okno: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present.
Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.
OS was defined as time from date of start of treatment to date of death due to any cause.
OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.
|
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Functional Assessment of Cancer Therapy-General (FACT-G)
Časové okno: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.
|
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
|
FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)
Časové okno: From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS. |
From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
- Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
- Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
- Motzer RJ, Hutson TE, Hudes GR, Figlin RA, Martini JF, English PA, Huang X, Valota O, Williams JA. Investigation of novel circulating proteins, germ line single-nucleotide polymorphisms, and molecular tumor markers as potential efficacy biomarkers of first-line sunitinib therapy for advanced renal cell carcinoma. Cancer Chemother Pharmacol. 2014 Oct;74(4):739-50. doi: 10.1007/s00280-014-2539-0. Epub 2014 Aug 7.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle histologického typu
- Novotvary
- Urologické novotvary
- Urogenitální novotvary
- Novotvary podle místa
- Onemocnění ledvin
- Urologická onemocnění
- Adenokarcinom
- Karcinom
- Novotvary, žlázové a epiteliální
- Novotvary ledvin
- Karcinom, renální buňka
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Antineoplastická činidla
- Inhibitory angiogeneze
- Činidla modulující angiogenezi
- Růstové látky
- Inhibitory růstu
- Inhibitory proteinkinázy
- Sunitinib
Další identifikační čísla studie
- A6181065
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