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NCT03785249

Estudio de fase 1/2 de MRTX849 en pacientes con cáncer que presentan una mutación KRAS G12C: KRYSTAL-1

Activo, No Reclutando Fase 1

Descripción

Este estudio evaluará la seguridad, la tolerabilidad, los niveles del fármaco, los efectos moleculares y la actividad clínica de MRTX849 (adagrasib) en pacientes con tumores sólidos avanzados que presentan una mutación KRAS G12C.

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

Fármaco / régimen ORR SLP (m) Fase / n Evidencia Fuente
mFOLFOXIRI + Panitumumab contexto de la diana 75% — Phase 3 / n=218 1 PMID 41505697 · 2026
mFOLFOX + Panitumumab contexto de la diana 78% — Phase 3 / n=217 1 PMID 41505697 · 2026
Sotorasib 960mg + Panitumumab contexto de la diana 30.2% — Phase 3 / n=53 1 PMID 40215429 · 2025
Sotorasib 240mg + Panitumumab contexto de la diana 7.5% — Phase 3 / n=53 1 PMID 40215429 · 2025
Sotorasib + Panitumumab contexto de la diana 26.4% 5.6 Phase 3 / n=160 1 PMID 38657256 · 2024
Panitumumab + mFOLFOX6 contexto de la diana 80.2% 13.7 Phase 3 / n=400 1 PMID 37589978 · 2023

Criterios de Elegibilidad

Criterios de inclusión:

  • Diagnóstico histológico confirmado de una neoplasia maligna de tumor sólido con mutación KRAS G12C
  • Enfermedad irresecable o metastásica
  • No hay tratamiento estándar disponible o el paciente se niega; tratamiento de primera línea para el CPN para ciertos grupos
  • Función orgánica adecuada

Criterios de exclusión:

  • Antecedentes de enfermedad intestinal o cirugía gástrica mayor o incapacidad para tragar medicamentos orales
  • Otro cáncer activo

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Información del Ensayo

NCT03785249
Activo, No Reclutando
Fase 1
731 participantes
Ene 2019
Dic 2026

Ubicaciones222

Puerto Rico (1)
Local Institution - 001-900
San Juan, PR, 00935
United States (221)
Local Institution - 001-826
Birmingham, Alabama, 35294
Local Institution - 001-965
Anchorage, Alaska, 99508
Local Institution - 001-821
Phoenix, Arizona, 85054
Local Institution - 001-873
Tucson, Arizona, 85704
Local Institution - 001-873-A
Tucson, Arizona, 85704
Local Institution - 001-840-B
Bellflower, California, 90706
Local Institution - 001-834
Beverly Hills, California, 90211
Local Institution - 001-843
Duarte, California, 91010
Local Institution - 001-850-K
Dublin, California, 94568
Local Institution - 001-851
Fullerton, California, 92835
Local Institution - 001-840-C
Harbor City, California, 90710
Local Institution - 001-805
La Jolla, California, 92093
Local Institution - 001-779
Los Alamitos, California, 90720
Local Institution - 001-578
Los Angeles, California, 90067
Local Institution - 001-840
Los Angeles, California, 90027
Local Institution - 001-847
Newport Beach, California, 92663
Local Institution - 001-850-B
Oakland, California, 94611
Local Institution - 001-803
Orange, California, 92868
Local Institution - 001-850-C
Roseville, California, 95661
Local Institution - 001-850-D
Sacramento, California, 95825
Local Institution - 001-850-J
Sacramento, California, 95814
Local Institution - 001-840-A
San Diego, California, 92120
Local Institution - 001-845
San Diego, California, 92111
Local Institution - 001-850-E
San Francisco, California, 94115
Local Institution - 001-850-H
San Francisco, California, 94080
Local Institution - 001-850-F
San Jose, California, 95119
Local Institution - 001-850-A
San Leandro, California, 94577
Local Institution - 001-884
Santa Barbara, California, 93105
Local Institution - 001-850-I
Santa Clara, California, 95051
Local Institution - 001-884-A
Solvang, California, 93463
Local Institution - 001-850
Vallejo, California, 94589
Local Institution - 001-850-G
Walnut Creek, California, 94596
Local Institution - 001-810
Aurora, Colorado, 80045
Local Institution - 001-872
Aurora, Colorado, 80012
Local Institution - 001-872-H
Boulder, Colorado, 80303
Local Institution - 001-872-E
Colorado Springs, Colorado, 80907
Local Institution - 001-872-L
Colorado Springs, Colorado, 80920
Local Institution - 001-872-B
Denver, Colorado, 80218
Local Institution - 001-951 - A
Denver, Colorado, 80218
Local Institution - 001-951 - B
Denver, Colorado, 80218
Local Institution - 001-846
Grand Junction, Colorado, 81501
Local Institution - 001-951
Lafayette, Colorado, 80026
Local Institution - 001-872-A
Lakewood, Colorado, 80228
Local Institution - 001-872-D
Littleton, Colorado, 80218
Local Institution - 001-872-K
Lone Tree, Colorado, 80124
Local Institution - 001-872-C
Longmont, Colorado, 80501
Local Institution - 001-872-J
Parker, Colorado, 80138
Local Institution - 001-872-F
Pueblo, Colorado, 81008
Local Institution - 001-872-G
Pueblo, Colorado, 81008
Local Institution - 001-872-I
Thornton, Colorado, 80260
Local Institution - 001-816
New Haven, Connecticut, 06510
Local Institution - 001-871
Newark, Delaware, 19713-2055
Local Institution - 001-929i
Altamonte Springs, Florida, 32701
Local Institution - 001-839
Boca Raton, Florida, 33432
Local Institution - 001-922A
Bonita Springs, Florida, 34135
Local Institution - 001-922D
Bradenton, Florida, 34211
Local Institution - 001-929c
Brandon, Florida, 33511
Local Institution - 001-922E
Cape Coral, Florida, 33909
Local Institution - 001-929g
Clearwater, Florida, 33761
Local Institution - 001-926b
Daytona Beach, Florida, 32117
Local Institution - 001-922
Fort Myers, Florida, 33901
Local Institution - 001-922B
Fort Myers, Florida, 33905
Local Institution - 001-922C
Fort Myers, Florida, 33908
Local Institution - 001-929b
Gainesville, Florida, 32605
Local Institution - 001-829
Jacksonville, Florida, 32224
Local Institution - 001-929m
Lady Lake, Florida, 32159
Local Institution - 001-929e
Largo, Florida, 33770
Local Institution - 001-929n
Lecanto, Florida, 34461
Local Institution - 001-870
Miami, Florida, 33176
Local Institution - 001-825
Miami Beach, Florida, 33140
Local Institution - 001-922F
Naples, Florida, 34102
Local Institution - 001-922G
Naples, Florida, 34102
Local Institution - 001-538
Ocala, Florida, 34474
Local Institution - 001-929p
Ocala, Florida, 34474
Local Institution - 001-914
Orange City, Florida, 32763
Local Institution - 001-929j
Orange City, Florida, 32763
Local Institution - 001-929l
Orlando, Florida, 32806
Local Institution - 001-877
Pensacola, Florida, 32503
Local Institution - 001-922H
Port Charlotte, Florida, 33980
Local Institution - 001-922I
Sarasota, Florida, 34232
Local Institution - 001-922J
Sarasota, Florida, 34236
Local Institution - 001-929h
Spring Hill, Florida, 34608
Local Institution - 001-929
St. Petersburg, Florida, 33705
Local Institution - 001-929a
St. Petersburg, Florida, 33705
Local Institution - 001-926d
Stuart, Florida, 34994
Local Institution - 001-929d
Tampa, Florida, 33607
Local Institution - 001-929k
Tavares, Florida, 32778
Local Institution - 001-929f
Trinity, Florida, 34655
Local Institution - 001-922K
Venice, Florida, 34285
Local Institution - 001-922L
Venice, Florida, 34292
Local Institution - 001-926c
Vero Beach, Florida, 32960
Local Institution - 001-926a
Wellington, Florida, 33414
Local Institution - 001-926
West Palm Beach, Florida, 33401
Local Institution - 001-929o
Winter Park, Florida, 32789
Local Institution - 001-967
Athens, Georgia, 30607
Local Institution - 001-835-C
Austell, Georgia, 30106
Local Institution - 001-835-E
Austell, Georgia, 30106
Local Institution - 001-835-D
Carrollton, Georgia, 30117
Local Institution - 001-835-F
Carrollton, Georgia, 30117
Local Institution - 001-835-A
Cartersville, Georgia, 30121
Local Institution - 001-835-B
Douglasville, Georgia, 30134
Local Institution - 001-835
Marietta, Georgia, 30060
Local Institution - 001-862
Chicago Ridge, Illinois, 60415
Local Institution - 001-883
Niles, Illinois, 60714
Local Institution - 001-781
South Bend, Indiana, 46601
Local Institution - 001-831
Iowa City, Iowa, 52242
Local Institution - 001-820
Westwood, Kansas, 66205
Local Institution - 001-844
Lexington, Kentucky, 40536
Local Institution - 001-920
Baton Rouge, Louisiana, 70809
Local Institution - 001-827
Biddeford, Maine, 04005
Local Institution - 001-881-B
Brandywine, Maryland, 20613
Local Institution - 001-881
Columbia, Maryland, 21044
Local Institution - 001-881-A
Silver Spring, Maryland, 20904
Local Institution - 001-808
Boston, Massachusetts, 02215
Local Institution - 001-811
Detroit, Michigan, 48202
Local Institution - 001-842
Detroit, Michigan, 48201
Local Institution - 001-842-A
Farmington Hills, Michigan, 48334
Local Institution - 001-838-F
Coon Rapids, Minnesota, 55433
Local Institution - 001-838-E
Edina, Minnesota, 55435
Local Institution - 001-875 - D
Edina, Minnesota, 55435
Local Institution - 001-838-D
Maplewood, Minnesota, 55109
Local Institution - 001-875 - A
Maplewood, Minnesota, 55109
Local Institution - 001-822
Minneapolis, Minnesota, 55455
Local Institution - 001-822-A
Minneapolis, Minnesota, 55455
Local Institution - 001-838-C
Minneapolis, Minnesota, 55404
Local Institution - 001-838-G
Minneapolis, Minnesota, 55415
Local Institution - 001-875
Minneapolis, Minnesota, 55404
Local Institution - 001-830
Rochester, Minnesota, 55905
Local Institution - 001-838
Saint Louis Park, Minnesota, 55416
Local Institution - 001-838-B
Saint Louis Park, Minnesota, 55426-5000
Local Institution - 001-838-A
Saint Paul, Minnesota, 55101
Local Institution - 001-875 - B
Saint Paul, Minnesota, 55102
Local Institution - 001-875 - C
Woodbury, Minnesota, 55125
Local Institution - 001-952
Bolivar, Missouri, 65613
Local Institution - 001-950
Jefferson City, Missouri, 65109
Local Institution - 001-841
Billings, Montana, 59102
Local Institution - 001-544
Omaha, Nebraska, 68198
Local Institution - 001-544A
Omaha, Nebraska, 68118
Local Institution - 001-544B
Omaha, Nebraska, 68105-1850
Local Institution - 001-959
Omaha, Nebraska, 68114
Local Institution - 001-860
Henderson, Nevada, 89074
Local Institution - 001-860A
Henderson, Nevada, 89052
Local Institution - 001-860B
Henderson, Nevada, 89074
Local Institution - 001-860C
Henderson, Nevada, 89052
Local Institution - 001-860D
Las Vegas, Nevada, 89144
Local Institution - 001-860E
Las Vegas, Nevada, 89128
Local Institution - 001-860F
Las Vegas, Nevada, 89148
Local Institution - 001-861
Albany, New York, 12206
Local Institution - 001-815
Buffalo, New York, 14203
Local Institution - 001-806
New York, New York, 10065
Local Institution - 001-813
New York, New York, 10016
Local Institution - 001-812
Chapel Hill, North Carolina, 27514
Local Institution - 001-971
Pinehurst, North Carolina, 28374
Local Institution - 001-823
Cincinnati, Ohio, 45267
Local Institution - 001-966
Cincinnati, Ohio, 45219
Local Institution - 001-818
Cleveland, Ohio, 44195
Local Institution - 001-833
Columbus, Ohio, 43210
Local Institution - 001-833 - A
Columbus, Ohio, 43210
Local Institution - 001-833 - B
Columbus, Ohio, 43221
Local Institution - 001-833 - C
Columbus, Ohio, 43203
Local Institution - 001-833 - D
Columbus, Ohio, 43212
Local Institution - 001-833 - F
Columbus, Ohio, 43210
Local Institution - 001-833 - G
Columbus, Ohio, 43221
Local Institution - 001-833 - H
Columbus, Ohio, 43201
Local Institution - 001-833 - I
Columbus, Ohio, 43212
Local Institution - 001-833 - J
Columbus, Ohio, 43203
Local Institution - 001-930
Columbus, Ohio, 43219
Local Institution - 001-833 - E
Gahanna, Ohio, 43230
Local Institution - 001-836
Kettering, Ohio, 45429
Local Institution - 001-836-A
Kettering, Ohio, 45429
Local Institution - 001-600
Lawton, Oklahoma, 73505
Local Institution - 001-584
Tulsa, Oklahoma, 74146
Local Institution - 001-586
Bend, Oregon, 97701
Local Institution - 001-586-A
Bend, Oregon, 97701
Local Institution - 001-889
Eugene, Oregon, 97401
Local Institution - 001-837
Allentown, Pennsylvania, 18103
Local Institution - 001-837-A
Bethlehem, Pennsylvania, 18017
Local Institution - 001-817
Hershey, Pennsylvania, 17033-0850
Local Institution - 001-783
Media, Pennsylvania, 19063
Local Institution - 001-819
Charleston, South Carolina, 29425
Local Institution - 001-887
Charleston, South Carolina, 29414
Local Institution - 001-801-G
Gallatin, Tennessee, 37066
Local Institution - 001-801-A
Hendersonville, Tennessee, 37075
Local Institution - 001-801-D
Hermitage, Tennessee, 37076
Local Institution - 001-801-F
Murfreesboro, Tennessee, 37129
Local Institution - 001-801
Nashville, Tennessee, 37203
Local Institution - 001-801-B
Nashville, Tennessee, 37203
Local Institution - 001-801-C
Nashville, Tennessee, 37211
Local Institution - 001-801-E
Nashville, Tennessee, 37207
Local Institution - 001-888
Arlington, Texas, 76012
Local Institution - 001-888-B
Arlington, Texas, 76012
Local Institution - 001-880
Austin, Texas, 78731
Local Institution - 001-848a
Conroe, Texas, 77384
Local Institution - 001-809
Dallas, Texas, 75230
Local Institution - 001-879
Dallas, Texas, 75246
Local Institution - 001-886
Dallas, Texas, 75231
Local Institution - 001-785
Denison, Texas, 75020
Local Institution - 001-876
Fort Worth, Texas, 76104
Local Institution - 001-848
Houston, Texas, 77030
Local Institution - 001-935A
Houston, Texas, 77090
Local Institution - 001-969
Houston, Texas, 77030
Local Institution - 001-999
Irving, Texas, 75063
Local Institution - 001-935
Kingwood, Texas, 77339
Local Institution - 001-935D
Kingwood, Texas, 77339
Local Institution - 001-554
Midland, Texas, 79701
Local Institution - 001-802
San Antonio, Texas, 78229
Local Institution - 001-935B
Shenandoah, Texas, 77380
Local Institution - 001-935C
Spring, Texas, 77389
Local Institution - 001-874
Sugar Land, Texas, 77479
Local Institution - 001-935E
Tomball, Texas, 77375
Local Institution - 001-878
Tyler, Texas, 75702
Local Institution - 001-890
Waco, Texas, 76712
Local Institution - 001-814
Fairfax, Virginia, 22031
Local Institution - 001-597
Fredericksburg, Virginia, 24408
Local Institution - 001-882
Newport News, Virginia, 23606
Local Institution - 001-882-A
Norfolk, Virginia, 23502
Local Institution - 001-890-A
Norfolk, Virginia, 23502
Local Institution - 001-968
Richmond, Virginia, 23229
Local Institution - 001-824
Seattle, Washington, 98109
Local Institution - 001-885
Vancouver, Washington, 98684
Local Institution - 001-804
Madison, Wisconsin, 53792

Fuente Oficial

Ver en ClinicalTrials.gov