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NCT04793958

Estudio de fase III de MRTX849 en combinación con cetuximab frente a quimioterapia en pacientes con cáncer colorrectal avanzado con mutación KRAS G12C (KRYSTAL-10)

Activo, No Reclutando Fase 3

Descripción

El estudio CA239-0006 es un ensayo clínico abierto, aleatorizado, de fase III que compara la eficacia de MRTX849 administrado en combinación con cetuximab frente a la quimioterapia en el tratamiento de segunda línea en pacientes con CRC con mutación KRAS G12C.

Evidencia de la diana molecular en cáncer colorrectal (KRAS/RAS)

Fármaco / régimen ORR SLP (m) Fase / n Evidencia Fuente
FOLFOX + Cetuximab (left-sided) este fármaco 68% 12 Phase 3 / n=325 1 PMID 28632484 · 2017
FOLFIRI + Cetuximab (left-sided) este fármaco 66% 11.8 Phase 3 / n=295 1 PMID 28632485 · 2017
Cetuximab + FOLFIRI este fármaco 57.3% 9.9 Phase 3 / n=316 1 PMID 19228967 · 2009
Cetuximab + FOLFOX este fármaco 61% 8.3 Phase 2 / n=169 1 PMID 19307505 · 2009
Cetuximab monotherapy este fármaco 13% 3.7 Phase 3 / n=287 1 PMID 18602412 · 2008
Cetuximab + Irinotecan este fármaco 22.9% 4 Phase 3 / n=218 1 PMID 17906451 · 2007

Criterios de Elegibilidad

Criterios de inclusión:

  • Diagnóstico histológicamente confirmado de carcinoma colorrectal con mutación KRAS G12C en el tejido tumoral.
  • Haber recibido previamente tratamiento de primera línea en el cáncer colorrectal avanzado con un régimen de quimioterapia a base de fluoropirimidina que contenga oxaliplatino o irinotecán, y haber presentado progresión radiográfica de la enfermedad durante o después del tratamiento.

Criterios de exclusión:

  • Haber recibido previamente tratamiento con una terapia dirigida a la mutación KRAS G12C (por ejemplo, AMG 510).
  • Haber recibido previamente tratamiento con un anticuerpo anti-EGFR (por ejemplo, cetuximab o panitumumab).
  • Metástasis cerebrales activas.

Información del Ensayo

NCT04793958
Activo, No Reclutando
Fase 3
461 participantes
Jun 2021
Ene 2026

Ubicaciones419

Argentina (6)
Local Institution - 010-431
Buenos Aires
Local Institution - 010-434
Buenos Aires
Local Institution - 010-432
CABA
Local Institution - 010-430
La Rioja
Local Institution - 010-448
Porto Alegre
Local Institution - 010-433
Viedma
Australia (6)
Local Institution - 010-005
Bedford Park
Local Institution - 010-004
Clayton
Local Institution - 010-006
Garran
Local Institution - 010-015
Heidelberg
Local Institution - 010-012
Melbourne
Local Institution - 010-002
Waratah
Austria (3)
Local Institution - 010-145
Innsbruck
Local Institution - 010-144
Vienna
Local Institution - 010-143
Wiener Neustadt
Belgium (4)
Local Institution - 010-154
Brussels
Local Institution - 010-157
Edegem
Local Institution - 010-156
Ghent
Local Institution - 010-150
Yvoir
Brazil (10)
Local Institution - 010-450
Blumenau
Local Institution - 010-442
Curitiba
Local Institution - 010-446
Ijuí
Local Institution - 010-449
Liberdade
Local Institution - 010-443
Porto Alegre
Local Institution - 010-444
Santo André
Local Institution - 010-440
São José do Rio Preto
Local Institution - 010-441
São Paulo
Local Institution - 010-445
São Paulo
Local Institution - 010-447
São Paulo
Canada (4)
Local Institution - 010-487
Montreal
Local Institution - 010-481
Ottawa
Local Institution - 010-482
Toronto
Local Institution - 010-483
Toronto
China (33)
Local Institution - 010-717
Beijing
Local Institution - 010-712
Bengbu
Local Institution - 010-030
Changchun
Local Institution - 010-718
Changchun
Local Institution - 010-035
Changsha
Local Institution - 010-710
Chengdu
Local Institution - 010-029
Fuzhou
Local Institution - 010-031
Guangzhou
Local Institution - 010-032
Hangzhou
Local Institution - 010-034
Hangzhou
Local Institution - 010-707
Hangzhou
Local Institution - 010-022
Hefei
Local Institution - 010-026
Hefei
Local Institution - 010-711
Hefei
Local Institution - 010-033
Hongkou Qu
Local Institution - 010-714
Jiangyin
Local Institution - 010-036
Jinan
Local Institution - 010-706
Nanchang
Local Institution - 010-704
Nanjing
Local Institution - 010-715
Nanning
Local Institution - 010-716
Neijiang
Local Institution - 010-020
Shanghai
Local Institution - 010-038
Shanghai
Local Institution - 010-708
Shanghai
Local Institution - 010-025
Shanghai Shi
Local Institution - 010-024
Shanghaishi
Local Institution - 010-705
Shenyang
Local Institution - 010-709
Shenyang
Local Institution - 010-713
Shenzhen
Local Institution - 010-027
Tianjin
Local Institution - 010-701
Wuhan
Local Institution - 010-703
Wuhan
Local Institution - 010-021
Zhengzhou
Colombia (4)
Local Institution - 010-460
Barranquilla
Local Institution - 010-462
Bogotá
Local Institution - 010-465
Floridablanca
Local Institution - 010-463
Medellín
Czechia (4)
Local Institution - 010-160
Brno
Local Institution - 010-165
Brno
Local Institution - 010-162
Olomouc
Local Institution - 010-161
Prague
Denmark (3)
Local Institution - 010-171
Copenhagen
Local Institution - 010-172
Odense
Local Institution - 010-170
Vejle
Finland (3)
Local Institution - 010-180
Helsinki
Local Institution - 010-182
Tampere
Local Institution - 010-181
Turku
France (18)
Local Institution - 010-668
Avignon
Local Institution - 010-208
Besançon
Local Institution - 010-669
Bordeaux
Local Institution - 010-194
Brest
Local Institution - 010-209-A
Chambray-lès-Tours
Local Institution - 010-192
Dijon
Local Institution - 010-662
Lille
Local Institution - 010-205
Lyon
Local Institution - 010-682
Marseille
Local Institution - 010-203
Paris
Local Institution - 010-204
Paris
Local Institution - 010-207
Paris
Local Institution - 010-661
Paris
Local Institution - 010-660
Pessac
Local Institution - 010-667
Suresnes
Local Institution - 010-680
Toulouse
Local Institution - 010-209
Tours
Local Institution - 010-202
Villejuif
Germany (12)
Local Institution - 010-675
Amberg
Local Institution - 010-657
Berlin
Local Institution - 010-655
Bochum
Local Institution - 010-227
Dresden
Local Institution - 010-229
Frankfurt am Main
Local Institution - 010-656
Hamburg
Local Institution - 010-658
Herne
Local Institution - 010-228
Mönchengladbach
Local Institution - 010-226
München
Local Institution - 010-650
München
Local Institution - 010-652
Reutlingen
Local Institution - 010-676
Ulm
Greece (6)
Local Institution - 010-501
Athens
Local Institution - 010-232
Cholargós
Local Institution - 010-238
Heraklion
Local Institution - 010-235
Larissa
Local Institution - 010-230
Thessaloniki
Local Institution - 010-231
Thessaloniki
Hong Kong (2)
Local Institution - 010-048
Central
Local Institution - 010-046
Hong Kong
Ireland (5)
Local Institution - 010-250
Dublin
Local Institution - 010-251
Dublin
Local Institution - 010-252
Dublin
Local Institution - 010-253
Dublin
Local Institution - 010-254
Dublin
Italy (14)
Local Institution - 010-292
Avellino
Local Institution - 010-290
Biella
Local Institution - 010-299
Cagliari
Local Institution - 010-286
Candiolo
Local Institution - 010-287
Lido di Camaiore
Local Institution - 010-270
Meldola
Local Institution - 010-278
Milan
Local Institution - 010-293
Milan
Local Institution - 010-271
Naples
Local Institution - 010-297
Padova
Local Institution - 010-294
Pisa
Local Institution - 010-291
Reggio Emilia
Local Institution - 010-295
Roma
Local Institution - 010-289
Torino
Malaysia (6)
Local Institution - 010-070
Johor Bahru
Local Institution - 010-077
Kota Kinabalu
Local Institution - 010-073
Kuala Lumpur
Local Institution - 010-074
Kuala Lumpur
Local Institution - 010-071
Petaling Jaya
Local Institution - 010-072
Putrajaya
Mexico (7)
Local Institution - 010-471
Colonia Centro Orizaba
Local Institution - 010-476
Cuernavaca
Local Institution - 010-472
Guadalajara
Local Institution - 010-477
Guadalajara
Local Institution - 010-473
Mexico City
Local Institution - 010-475
San Juan del Río
Local Institution - 010-474
Tuxtla Gutiérrez
Netherlands (4)
Local Institution - 010-306
Amsterdam
Local Institution - 010-632
Amsterdam
Local Institution - 010-630
Nijmegen
Local Institution - 010-307
Utrecht
Poland (4)
Local Institution - 010-328
Gdansk
Local Institution - 010-327
Otwock
Local Institution - 010-322
Warsaw
Local Institution - 010-787
Warsaw
Portugal (5)
Local Institution - 010-332
Braga
Local Institution - 010-337
Lisbon
Local Institution - 010-640
Lisbon
Local Institution - 010-331
Porto
Local Institution - 010-339
Porto
Puerto Rico (3)
Local Institution - 010-900
San Juan
Local Institution - 010-902
San Juan
Local Institution - 010-903
San Juan
Romania (8)
Local Institution - 010-347
Baia Mare
Local Institution - 010-349
Brasov
Local Institution - 010-512
Bucharest
Local Institution - 010-340
Cluj-Napoca
Local Institution - 010-344
Cluj-Napoca
Local Institution - 010-343
Craiova
Local Institution - 010-511
Ovidiu
Local Institution - 010-510
Timișoara
Singapore (5)
Local Institution - 010-090
Singapore
Local Institution - 010-091
Singapore
Local Institution - 010-092
Singapore
Local Institution - 010-093
Singapore
Local Institution - 010-095
Singapore
South Korea (15)
Local Institution - 010-116
Anyang-si
Local Institution - 010-111
Busan
Local Institution - 010-119
Busan
Local Institution - 010-525
Daejeon
Local Institution - 010-117
Goyang-si
Local Institution - 010-100
Hwasun-gun
Local Institution - 010-520
Seongnam-si
Local Institution - 010-104
Seoul
Local Institution - 010-105
Seoul
Local Institution - 010-108
Seoul
Local Institution - 010-109
Seoul
Local Institution - 010-114
Seoul
Local Institution - 010-118
Seoul
Local Institution - 010-115
Suwon
Local Institution - 010-524
Yangsan
Spain (15)
Local Institution - 010-613
A Coruña
Local Institution - 010-610
Badalona
Local Institution - 010-600
Barcelona
Local Institution - 010-612
Barcelona
Local Institution - 010-621
Córdoba
Local Institution - 010-620
LHospitalet de Llobregat
Local Institution - 010-601
Madrid
Local Institution - 010-617
Madrid
Local Institution - 010-619
Madrid
Local Institution - 010-624
Madrid
Local Institution - 010-623
Pamplona
Local Institution - 010-622
Sabadell
Local Institution - 010-604
Santander
Local Institution - 010-618
Valencia
Local Institution - 010-625
Valencia
Taiwan (7)
Local Institution - 010-129
Changhua
Local Institution - 010-121
Kaohsiung City
Local Institution - 010-124
Taichung
Local Institution - 010-122
Tainan
Local Institution - 010-123
Tainan
Local Institution - 010-120
Taipei
Local Institution - 010-125
Taoyuan
Thailand (5)
Local Institution - 010-132
Bang Phlat
Local Institution - 010-134
Bangkok
Local Institution - 010-131
Chiang Mai
Local Institution - 010-130
Hat Yai
Local Institution - 010-133
Khlong Toey
Ukraine (1)
Local Institution - 010-424
Sumy
United Kingdom (12)
Local Institution - 010-412
Aberdeen
Local Institution - 010-410
Birmingham
Local Institution - 010-413
Cambridge
Local Institution - 010-411
Dorset
Local Institution - 010-400
Glasgow
Local Institution - 010-403
Kent
Local Institution - 010-414
Leeds
Local Institution - 010-402
London
Local Institution - 010-405
London
Local Institution - 010-406
London
Local Institution - 010-407
Manchester
Local Institution - 010-404
Middlesex
United States (185)
Local Institution - 010-855-E
Alabaster
Local Institution - 010-976-F
American Fork
Local Institution - 010-956
Atlanta
Local Institution - 010-533 A
Auburn
Local Institution - 010-810
Aurora
Local Institution - 010-872-H
Aurora
Local Institution - 010-535 - D
Babylon
Local Institution - 010-573
Bakersfield
Local Institution - 010-534
Baltimore
Local Institution - 010-918 - B
Basking Ridge
Local Institution - 010-920
Baton Rouge
Local Institution - 010-993
Belleville
Local Institution - 010-855-B
Bessemer
Local Institution - 010-855
Birmingham
Local Institution - 010-855-A
Birmingham
Local Institution - 010-855-C
Birmingham
Local Institution - 010-855-D
Birmingham
Local Institution - 010-855-F
Birmingham
Local Institution - 010-922-A
Bonita Springs
Local Institution - 010-997
Boston
Local Institution - 010-872-A
Boulder
Local Institution - 010-976-C
Bountiful
Local Institution - 010-922-D
Bradenton
Local Institution - 010-531A
Brownstown
Local Institution - 010-922-E
Cape Coral
Local Institution - 010-872-E
Centennial
Local Institution - 010-921
Chattanooga
Local Institution - 010-979C
Chula Vista
Local Institution - 010-893
Cincinnati
Local Institution - 010-585-B
Clinton
Local Institution - 010-872-C
Colorado Springs
Local Institution - 010-918 - A
Commack
Local Institution - 010-572
Dallas
Local Institution - 010-879
Dallas
Local Institution - 010-531C
Dearborn
Local Institution - 010-872
Denver
Local Institution - 010-872-B
Denver
Local Institution - 010-531
Detroit
Local Institution - 010-975
East Brunswick
Local Institution - 010-576
Everett
Local Institution - 010-919
Fairfax
Local Institution - 010-992
Florham Park
Local Institution - 010-922
Fort Myers
Local Institution - 010-922-B
Fort Myers
Local Institution - 010-922-C
Fort Myers
Local Institution - 010-597
Fredericksburg
Local Institution - 010-980
Fresno
Local Institution - 010-851
Fullerton
Local Institution - 010-533 B
Gig Harbor
Local Institution - 010-996
Gilbert
Local Institution - 010-585
Goldsboro
Local Institution - 010-566
Goodyear
Local Institution - 010-981
Greenville
Local Institution - 010-918 - F
Harrison
Local Institution - 010-860 - A
Henderson
Local Institution - 010-860-B
Henderson
Local Institution - 010-860-F
Henderson
Local Institution - 010-984-B
Holiday
Local Institution - 010-577
Houston
Local Institution - 010-577-A
Houston
Local Institution - 010-577-B
Houston
Local Institution - 010-848
Houston
Local Institution - 010-977
Houston
Local Institution - 010-569
Indianapolis
Local Institution - 010-569-A
Indianapolis
Local Institution - 010-991
Iowa City
Local Institution - 010-999
Irving
Local Institution - 010-585-A
Jacksonville
Local Institution - 010-829
Jacksonville
Local Institution - 010-979A
La Mesa
Local Institution - 010-872-J
Lakewood
Local Institution - 010-923-A
Largo
Local Institution - 010-923-B
Largo
Local Institution - 010-923-C
Largo
Local Institution - 010-923-D
Largo
Local Institution - 010-923-E
Largo
Local Institution - 010-923-F
Largo
Local Institution - 010-923-G
Largo
Local Institution - 010-923-H
Largo
Local Institution - 010-923-I
Largo
Local Institution - 010-923-J
Largo
Local Institution - 010-923-K
Largo
Local Institution - 010-923-L
Largo
Local Institution - 010-923-M
Largo
Local Institution - 010-923-N
Largo
Local Institution - 010-923-O
Largo
Local Institution - 010-923-P
Largo
Local Institution - 010-860
Las Vegas
Local Institution - 010-860-C
Las Vegas
Local Institution - 010-860-D
Las Vegas
Local Institution - 010-860-E
Las Vegas
Local Institution - 010-976-D
Layton
Local Institution - 010-564
Lincoln
Local Institution - 010-872-F
Littleton
Local Institution - 010-872-G
Longmont
Local Institution - 010-878-B
Longview
Local Institution - 010-551
Los Angeles
Local Institution - 010-958
Los Angeles
Local Institution - 010-958A
Los Angeles
Local Institution - 010-990
Miami
Local Institution - 010-918 - D
Middletown
Local Institution - 010-947
Milwaukee
Local Institution - 010-875
Minneapolis
Local Institution - 010-918 - C
Montvale
Local Institution - 010-575
Morgantown
Local Institution - 010-976-A
Murray
Local Institution - 010-963
Naperville
Local Institution - 010-922-F
Naples
Local Institution - 010-922-G
Naples
Local Institution - 010-801
Nashville
Local Institution - 010-957
New Brunswick
Local Institution - 010-535 - G
New York
Local Institution - 010-813
New York
Local Institution - 010-918
New York
Local Institution - 010-998
New York
Local Institution - 010-986
Newnan
Local Institution - 010-847
Newport Beach
Local Institution - 010-949
Norwich
Local Institution - 010-531B
Novi
Local Institution - 010-538
Ocala
Local Institution - 010-976-H
Ogden
Local Institution - 010-532
Oklahoma City
Local Institution - 010-549
Oklahoma City
Local Institution - 010-590
Omaha
Local Institution - 010-896
Orlando
Local Institution - 010-988
Orlando
Local Institution - 010-535 - C
Patchogue
Local Institution - 010-989
Phoenix
Local Institution - 010-596
Pittsburgh
Local Institution - 010-922-H
Port Charlotte
Local Institution - 010-535 - A
Port Jefferson
Local Institution - 010-535 - B
Port Jefferson Station
Local Institution - 010-976-G
Provo
Local Institution - 010-872-I
Pueblo
Local Institution - 010-533 C
Puyallup
Local Institution - 010-563
Redlands
Local Institution - 010-536
Richmond
Local Institution - 010-539
Richmond
Local Institution - 010-535 - F
Riverhead
Local Institution - 010-830
Rochester
Local Institution - 010-838
Saint Louis Park
Local Institution - 010-838A
Saint Louis Park
Local Institution - 010-838B
Saint Louis Park
Local Institution - 010-838C
Saint Louis Park
Local Institution - 010-838D
Saint Louis Park
Local Institution - 010-838E
Saint Louis Park
Local Institution - 010-838F
Saint Louis Park
Local Institution - 010-838G
Saint Louis Park
Local Institution - 010-838H
Saint Louis Park
Local Institution - 010-838I
Saint Louis Park
Local Institution - 010-838J
Saint Louis Park
Local Institution - 010-838K
Saint Louis Park
Local Institution - 010-838L
Saint Louis Park
Local Institution - 010-838M
Saint Louis Park
Local Institution - 010-976
Salt Lake City
Local Institution - 010-976-B
Salt Lake City
Local Institution - 010-862
San Antonio
Local Institution - 010-979
San Diego
Local Institution - 010-979B
San Diego
Local Institution - 010-979D
San Diego
Local Institution - 010-982
San Francisco
Local Institution - 010-561
Santa Monica
Local Institution - 010-824
Seattle
Local Institution - 010-535
Shirley
Local Institution - 010-978
Springdale
Local Institution - 010-541
Springfield
Local Institution - 010-923
St. Petersburg
Local Institution - 010-984
St. Petersburg
Local Institution - 010-571
Sylmar
Local Institution - 010-533
Tacoma
Local Institution - 010-924
Tallahassee
Local Institution - 010-964
Temple
Local Institution - 010-535 - E
The Bronx
Local Institution - 010-872-D
Thornton
Local Institution - 010-574
Torrance
Local Institution - 010-984-A
Trinity
Local Institution - 010-584
Tulsa
Local Institution - 010-878
Tyler
Local Institution - 010-918 - E
Uniondale
Local Institution - 010-885
Vancouver
Local Institution - 010-976-E
West Jordan
Local Institution - 010-926
West Palm Beach
Local Institution - 010-537
Weston
Local Institution - 010-570
Whittier
Local Institution - 010-994
Zion

Fuente Oficial

Ver en ClinicalTrials.gov