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NCT00561470

Aflibercept frente a placebo en combinación con irinotecán y 5-FU en el tratamiento de pacientes con cáncer colorrectal metastásico tras el fracaso de un régimen basado en oxaliplatino.

Archived Fase 3

Descripción

El objetivo principal del estudio fue evaluar la eficacia de aflibercept (en comparación con el placebo) para aumentar la supervivencia global en participantes con cáncer colorrectal metastásico tratados con FOLFIRI (irinotecán, 5-fluorouracilo y leucovorina) y que previamente no habían respondido a un tratamiento con oxaliplatino para la enfermedad metastásica.

Los objetivos secundarios fueron comparar la supervivencia libre de progresión, evaluar la tasa de respuesta global, evaluar el perfil de seguridad, evaluar la inmunogenicidad de aflibercept intravenoso (IV) y evaluar la farmacocinética de aflibercept IV en ambos grupos de tratamiento.

Evidencia de la diana molecular en cáncer colorrectal

Aún no hay evidencia documentada en nuestra base para la diana o el fármaco de este ensayo. Esta sección crece a medida que se procesan nuevas publicaciones.

Criterios de Elegibilidad

Se incluyeron en el estudio los participantes que cumplían los siguientes criterios de selección principales.

Criterios de inclusión:

  • Adenocarcinoma de colon o recto confirmado histológica o citológicamente.
  • Enfermedad metastásica que no es susceptible de un tratamiento potencialmente curativo.
  • Una y solo una línea de tratamiento previa para la enfermedad metastásica. Esta línea previa debe ser quimioterapia basada en oxaliplatino (los participantes que presentan una recaída dentro de los 6 meses posteriores a la finalización de la quimioterapia adyuvante basada en oxaliplatino son elegibles).
  • Se permite el tratamiento previo con bevacizumab.

Criterios de exclusión:

  • Terapia previa con irinotecán.
  • Estado funcional del Eastern Cooperative Oncology Group >2.

La información anterior no pretende incluir todas las consideraciones relevantes para la participación en un ensayo clínico.

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Información del Ensayo

NCT00561470
Archived
Fase 3
1226 participantes
Nov 2007

Ubicaciones221

Argentina (4)
Sanofi-Aventis Investigational Site Number 032003
Bahía Blanca, 8000
Sanofi-Aventis Investigational Site Number 032006
Buenos Aires, 1426ANZ
Sanofi-Aventis Investigational Site Number 032005
Ciudad de Buenos Aires, C1426BOR
Sanofi-Aventis Investigational Site Number 032007
Salta, 4400
Australia (7)
Sanofi-Aventis Investigational Site Number 036004
Hornsby, 2077
Sanofi-Aventis Investigational Site Number 036001
Kingswood, 2747
Sanofi-Aventis Investigational Site Number 036002
Kurralta Park, 5037
Sanofi-Aventis Investigational Site Number 036003
Melbourne, 3128
Sanofi-Aventis Investigational Site Number 036005
Melbourne, 3050
Sanofi-Aventis Investigational Site Number 036007
Nedlands, 6009
Sanofi-Aventis Investigational Site Number 036006
Subiaco, 6008
Austria (1)
Sanofi-Aventis Investigational Site Number 040001
Vienna, 1090
Belgium (7)
Sanofi-Aventis Investigational Site Number 056006
Bonheiden, 2820
Sanofi-Aventis Investigational Site Number 056002
Brussels, 1070
Sanofi-Aventis Investigational Site Number 056004
Brussels, 1200
Sanofi-Aventis Investigational Site Number 056007
Brussels, 1000
Sanofi-Aventis Investigational Site Number 056001
Ghent, 9000
Sanofi-Aventis Investigational Site Number 056005
Haine-Saint-Paul, 7100
Sanofi-Aventis Investigational Site Number 056003
Leuven, 3000
Brazil (8)
Sanofi-Aventis Investigational Site Number 076002
Porto Alegre, 90430090
Sanofi-Aventis Investigational Site Number 076004
Porto Alegre, 90035-003
Sanofi-Aventis Investigational Site Number 076005
Porto Alegre, 90110-270
Sanofi-Aventis Investigational Site Number 076003
Rio de Janeiro, 22260-020
Sanofi-Aventis Investigational Site Number 076008
Rio de Janeiro, 20231-050
Sanofi-Aventis Investigational Site Number 076001
Santo André, 09050-360
Sanofi-Aventis Investigational Site Number 076006
São Paulo, 01308050
Sanofi-Aventis Investigational Site Number 076007
São Paulo, 01246-000
Chile (5)
Sanofi-Aventis Investigational Site Number 152001
Santiago, 8380455
Sanofi-Aventis Investigational Site Number 152002
Santiago, 7510032
Sanofi-Aventis Investigational Site Number 152003
Santiago, 7650635
Sanofi-Aventis Investigational Site Number 152005
Santiago, 8380456
Sanofi-Aventis Investigational Site Number 152004
Viña del Mar, 2540364
Czechia (3)
Sanofi-Aventis Investigational Site Number 203001
Brno, 65653
Sanofi-Aventis Investigational Site Number 203002
Brno, 62500
Sanofi-Aventis Investigational Site Number 203004
Prague, 15006
Denmark (2)
Sanofi-Aventis Investigational Site Number 208003
Aalborg, 9100
Sanofi-Aventis Investigational Site Number 208001
Odense C, 5000
Estonia (2)
Sanofi-Aventis Investigational Site Number 233002
Tallinn, 13419
Sanofi-Aventis Investigational Site Number 233001
Tartu, 50406
France (5)
Sanofi-Aventis Investigational Site Number 250002
Brest, 29200
Sanofi-Aventis Investigational Site Number 250004
Clichy Cx, 92118
Sanofi-Aventis Investigational Site Number 250005
La Roche-sur-Yon, 85925
Sanofi-Aventis Investigational Site Number 250001
Lyon, 69437
Sanofi-Aventis Investigational Site Number 250003
Paris, 75013
Germany (6)
Sanofi-Aventis Investigational Site Number 276003
Aschaffenburg, 63739
Sanofi-Aventis Investigational Site Number 276002
Essen, 45147
Sanofi-Aventis Investigational Site Number 276001
Halle, 06120
Sanofi-Aventis Investigational Site Number 276004
Magdeburg, 39130
Sanofi-Aventis Investigational Site Number 276005
Magdeburg, 39104
Sanofi-Aventis Investigational Site Number 276006
München, 81737
Greece (5)
Sanofi-Aventis Investigational Site Number 300004
Athens, 11527
Sanofi-Aventis Investigational Site Number 300005
Athens, 11522
Sanofi-Aventis Investigational Site Number 300001
Heraklion, 71110
Sanofi-Aventis Investigational Site Number 300002
Ilion, Athens
Sanofi-Aventis Investigational Site Number 300003
Pátrai, 26500
Italy (8)
Sanofi-Aventis Investigational Site Number 380007
Ancona, 60032
Sanofi-Aventis Investigational Site Number 380005
Aviano, 33081
Sanofi-Aventis Investigational Site Number 380004
Candiolo, 10060
Sanofi-Aventis Investigational Site Number 380003
Genova, 16128
Sanofi-Aventis Investigational Site Number 380001
Milan, 20133
Sanofi-Aventis Investigational Site Number 380002
Milan, 20141
Sanofi-Aventis Investigational Site Number 380008
Rozzano, 20089
Sanofi-Aventis Investigational Site Number 380006
San Giovanni Rotondo, 71013
Netherlands (5)
Sanofi-Aventis Investigational Site Number 528004
Amsterdam, 1091 HA
Sanofi-Aventis Investigational Site Number 528001
Blaricum, 1261 AN
Sanofi-Aventis Investigational Site Number 528005
Breda, 4819 EV
Sanofi-Aventis Investigational Site Number 528002
Rotterdam, 3007 AC
Sanofi-Aventis Investigational Site Number 528003
Sittard-Geleen, 6162 BG
New Zealand (2)
Sanofi-Aventis Investigational Site Number 554009
Auckland, 1023
Sanofi-Aventis Investigational Site Number 554010
Christchurch
Norway (3)
Sanofi-Aventis Investigational Site Number 578002
Bergen, 5021
Sanofi-Aventis Investigational Site Number 578001
Oslo, 0407
Sanofi-Aventis Investigational Site Number 578003
Stavanger, 4011
Poland (7)
Sanofi-Aventis Investigational Site Number 616005
Częstochowa, 42-200
Sanofi-Aventis Investigational Site Number 616004
Elblag, 82-300
Sanofi-Aventis Investigational Site Number 616007
Krakow, 31-826
Sanofi-Aventis Investigational Site Number 616003
Lodz, 93-509
Sanofi-Aventis Investigational Site Number 616002
Poznan, 61-485
Sanofi-Aventis Investigational Site Number 616006
Rybnik, 44-200
Sanofi-Aventis Investigational Site Number 616001
Wroclaw, 53-413
Puerto Rico (1)
Sanofi-Aventis Investigational Site Number 630001
San Juan, 00927
Romania (7)
Sanofi-Aventis Investigational Site Number 642004
Alba Iulia, 510077
Sanofi-Aventis Investigational Site Number 642001
Bucharest, 022328
Sanofi-Aventis Investigational Site Number 642002
Bucharest, 022328
Sanofi-Aventis Investigational Site Number 642007
Bucharest, 050098
Sanofi-Aventis Investigational Site Number 642003
Cluj-Napoca, 400015
Sanofi-Aventis Investigational Site Number 642006
Iași, 700106
Sanofi-Aventis Investigational Site Number 642005
Suceava, 720237
Russia (6)
Sanofi-Aventis Investigational Site Number 643001
Moscow, 115478
Sanofi-Aventis Investigational Site Number 643002
Moscow, 129128
Sanofi-Aventis Investigational Site Number 643006
Moscow, 115478
Sanofi-Aventis Investigational Site Number 643003
Saint Petersburg, 197758
Sanofi-Aventis Investigational Site Number 643004
Saint Petersburg, 191104
Sanofi-Aventis Investigational Site Number 643007
Saint Petersburg, 197758
South Africa (7)
Sanofi-Aventis Investigational Site Number 710004
Cape Town, 7506
Sanofi-Aventis Investigational Site Number 710005
Durban, 4001
Sanofi-Aventis Investigational Site Number 710008
Durban, 4062
Sanofi-Aventis Investigational Site Number 710001
Parktown, 2193
Sanofi-Aventis Investigational Site Number 710006
Port Elizabeth, 6001
Sanofi-Aventis Investigational Site Number 710003
Pretoria, 0181
Sanofi-Aventis Investigational Site Number 710007
Pretoria, 0001
South Korea (5)
Sanofi-Aventis Investigational Site Number 410001
Goyang, 410-760
Sanofi-Aventis Investigational Site Number 410002
Seoul, 135-710
Sanofi-Aventis Investigational Site Number 410003
Seoul, 110-744
Sanofi-Aventis Investigational Site Number 410004
Seoul, 138-736
Sanofi-Aventis Investigational Site Number 410005
Seoul, 120-752
Spain (6)
Sanofi-Aventis Investigational Site Number 724002
Barakaldo, 48903
Sanofi-Aventis Investigational Site Number 724001
Barcelona, 08035
Sanofi-Aventis Investigational Site Number 724005
Barcelona, 08003
Sanofi-Aventis Investigational Site Number 724003
Madrid, 28041
Sanofi-Aventis Investigational Site Number 724006
Madrid, 28035
Sanofi-Aventis Investigational Site Number 724007
Reus, 43201
Sweden (3)
Sanofi-Aventis Investigational Site Number 752002
Stockholm, 171 76
Sanofi-Aventis Investigational Site Number 752003
Sundsvall, 851 86
Sanofi-Aventis Investigational Site Number 752001
Uppsala, 751 85
Turkey (Türkiye) (5)
Sanofi-Aventis Investigational Site Number 792005
Adana, 01120
Sanofi-Aventis Investigational Site Number 792001
Ankara, 06500
Sanofi-Aventis Investigational Site Number 792004
Ankara, 06100
Sanofi-Aventis Investigational Site Number 792002
Izmir, 35340
Sanofi-Aventis Investigational Site Number 792003
Kayseri, 38039
Ukraine (4)
Sanofi-Aventis Investigational Site Number 804005
Dnipropetrovsk
Sanofi-Aventis Investigational Site Number 804004
Donetsk, 83092
Sanofi-Aventis Investigational Site Number 804002
Kharkiv, 61070
Sanofi-Aventis Investigational Site Number 804006
Kharkiv, 61037
United Kingdom (10)
Sanofi-Aventis Investigational Site Number 826001
Aberdeen, AB25 2ZD
Sanofi-Aventis Investigational Site Number 826010
Bournemouth, BH7 7DW
Sanofi-Aventis Investigational Site Number 826009
Dudley, DY1 2HQ
Sanofi-Aventis Investigational Site Number 826004
London, N18 1QX
Sanofi-Aventis Investigational Site Number 826007
London, SE1 7EH
Sanofi-Aventis Investigational Site Number 826008
London, EC1A 7BE
Sanofi-Aventis Investigational Site Number 826011
London, SW3 6JJ
Sanofi-Aventis Investigational Site Number 826002
Manchester, M20 4BX
Sanofi-Aventis Investigational Site Number 826003
Northwood, HA6 2RN
Sanofi-Aventis Investigational Site Number 826005
Sutton, SM2 5PT
United States (87)
Sanofi-Aventis Investigational Site Number 840119
Birmingham, Alabama, 35203
Sanofi-Aventis Investigational Site Number 840074
Muscle Shoals, Alabama, 35661
Sanofi-Aventis Investigational Site Number 840093
Hot Springs, Arizona, 71913
Sanofi-Aventis Investigational Site Number 840080
Anaheim, California, 92801
Sanofi-Aventis Investigational Site Number 840076
Fountain Valley, California, 92708
Sanofi-Aventis Investigational Site Number 840120
Fountain Valley, California, 92708
Sanofi-Aventis Investigational Site Number 840073
Greenbrae, California, 94904-2007
Sanofi-Aventis Investigational Site Number 840101
Hayward, California, 94545
Sanofi-Aventis Investigational Site Number 840046
La Jolla, California, 92037
Sanofi-Aventis Investigational Site Number 840116
Loma Linda, California, 92354
Sanofi-Aventis Investigational Site Number 840048
Long Beach, California, 90813
Sanofi-Aventis Investigational Site Number 840201
Oakland, California, 94611
Sanofi-Aventis Investigational Site Number 840901
Roseville, California, 95678
Sanofi-Aventis Investigational Site Number 840042
Sacramento, California, 95816
Sanofi-Aventis Investigational Site Number 840301
Sacramento, California, 95825
Sanofi-Aventis Investigational Site Number 840112
Salinas, California, 93901-3906
Sanofi-Aventis Investigational Site Number 840006
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840106
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840206
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840306
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840406
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840506
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840606
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840706
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840806
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840906
San Diego, California, 92102
Sanofi-Aventis Investigational Site Number 840401
San Francisco, California, 94115
Sanofi-Aventis Investigational Site Number 840601
San Jose, California, 95119
Sanofi-Aventis Investigational Site Number 840501
Santa Clara, California, 95051
Sanofi-Aventis Investigational Site Number 840801
South San Francisco, California, 94080
Sanofi-Aventis Investigational Site Number 840001
Vallejo, California, 94589
Sanofi-Aventis Investigational Site Number 840701
Walnut Creek, California, 94596
Sanofi-Aventis Investigational Site Number 840071
Stamford, Connecticut, 06902
Sanofi-Aventis Investigational Site Number 840014
Newark, Delaware, 19718
Sanofi-Aventis Investigational Site Number 840089
Boynton Beach, Florida, 33435
Sanofi-Aventis Investigational Site Number 840031
Gainesville, Florida, 32610
Sanofi-Aventis Investigational Site Number 840041
Gainesville, Florida, 32608
Sanofi-Aventis Investigational Site Number 840122
Miami, Florida, 33176
Sanofi-Aventis Investigational Site Number 840079
The Villages, Florida, 32159
Sanofi-Aventis Investigational Site Number 840087
Chicago, Illinois, 60616
Sanofi-Aventis Investigational Site Number 840019
Decatur, Illinois, 62526
Sanofi-Aventis Investigational Site Number 840115
Elk Grove Village, Illinois, 60007
Sanofi-Aventis Investigational Site Number 840010
Naperville, Illinois, 60540
Sanofi-Aventis Investigational Site Number 840113
Quincy, Illinois, 62301
Sanofi-Aventis Investigational Site Number 840047
Indianapolis, Indiana, 46260
Sanofi-Aventis Investigational Site Number 840072
Indianapolis, Indiana, 46254
Sanofi-Aventis Investigational Site Number 840034
Munster, Indiana, 46321
Sanofi-Aventis Investigational Site Number 840088
Louisville, Kentucky, 40202
Sanofi-Aventis Investigational Site Number 840096
Paducah, Kentucky, 42003
Sanofi-Aventis Investigational Site Number 840043
Baton Rouge, Louisiana, 70809
Sanofi-Aventis Investigational Site Number 840084
Metairie, Louisiana, 70006
Sanofi-Aventis Investigational Site Number 840015
New Orleans, Louisiana, 70121
Sanofi-Aventis Investigational Site Number 840070
Rockville, Maryland, 20850
Sanofi-Aventis Investigational Site Number 840029
Salisbury, Maryland, 21801
Sanofi-Aventis Investigational Site Number 840053
Pontiac, Michigan, 48341
Sanofi-Aventis Investigational Site Number 840021
Saint Louis Park, Minnesota, 55416
Sanofi-Aventis Investigational Site Number 840081
Kansas City, Missouri, 64128
Sanofi-Aventis Investigational Site Number 840052
St Louis, Missouri, 63104
Sanofi-Aventis Investigational Site Number 840114
St Louis, Missouri, 63136
Sanofi-Aventis Investigational Site Number 840049
Las Vegas, Nevada, 89106
Sanofi-Aventis Investigational Site Number 840044
Albuquerque, New Mexico, 87131
Sanofi-Aventis Investigational Site Number 840036
Albany, New York, 12206
Sanofi-Aventis Investigational Site Number 840094
Lake Success, New York, 11042
Sanofi-Aventis Investigational Site Number 840017
Syracuse, New York, 13210
Sanofi-Aventis Investigational Site Number 840097
Syracuse, New York, 13210
Sanofi-Aventis Investigational Site Number 840035
Burlington, North Carolina, 27215
Sanofi-Aventis Investigational Site Number 840024
Charlotte, North Carolina, 28204
Sanofi-Aventis Investigational Site Number 840026
Charlotte, North Carolina, 28262
Sanofi-Aventis Investigational Site Number 840005
Goldsboro, North Carolina, 27534
Sanofi-Aventis Investigational Site Number 840004
Hendersonville, North Carolina, 28791
Sanofi-Aventis Investigational Site Number 840075
Winston-Salem, North Carolina, 27103
Sanofi-Aventis Investigational Site Number 840098
Cincinnati, Ohio, 45219
Sanofi-Aventis Investigational Site Number 840011
Kettering, Ohio, 45429
Sanofi-Aventis Investigational Site Number 840086
Middletown, Ohio, 45042
Sanofi-Aventis Investigational Site Number 840008
Toledo, Ohio, 43623
Sanofi-Aventis Investigational Site Number 840039
Portland, Oregon, 97227
Sanofi-Aventis Investigational Site Number 840118
Bethlehem, Pennsylvania, 18015
Sanofi-Aventis Investigational Site Number 840033
Philadelphia, Pennsylvania, 19107
Sanofi-Aventis Investigational Site Number 840012
Pittsburgh, Pennsylvania, 15212
Sanofi-Aventis Investigational Site Number 840082
Pawtucket, Rhode Island, 02860
Sanofi-Aventis Investigational Site Number 840095
Woonsocket, Rhode Island, 02895
Sanofi-Aventis Investigational Site Number 840085
Charleston, South Carolina, 29403
Sanofi-Aventis Investigational Site Number 840037
Spartanburg, South Carolina, 29303
Sanofi-Aventis Investigational Site Number 840078
Corpus Christi, Texas, 78405
Sanofi-Aventis Investigational Site Number 840117
Temple, Texas, 76508
Sanofi-Aventis Investigational Site Number 840099
Seattle, Washington, 98115
Sanofi-Aventis Investigational Site Number 840002
Marshfield, Wisconsin, 54449

Fuente Oficial

Ver en ClinicalTrials.gov