Volver a Ensayos Clínicos

NCT03600883

Un estudio de fase 1/2 que evalúa la seguridad, la tolerabilidad, la farmacocinética y la eficacia de sotorasib (AMG 510) en sujetos con tumores sólidos que presentan una mutación específica en el gen KRAS (CodeBreaK 100).

Completado Fase 1

Descripción

Evaluar la seguridad y tolerabilidad de sotorasib en pacientes adultos con tumores sólidos avanzados con mutación KRAS p.G12C.

Estimar la dosis máxima tolerada (DMT) y/o una dosis recomendada para la fase 2 (DRF2) en pacientes adultos con tumores sólidos avanzados con mutación KRAS p.G12C.

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

Fármaco / régimen ORR SLP (m) Fase / n Evidencia Fuente
Sotorasib 960mg + Panitumumab este fármaco 30.2% — Phase 3 / n=53 1 PMID 40215429 · 2025
Sotorasib 240mg + Panitumumab este fármaco 7.5% — Phase 3 / n=53 1 PMID 40215429 · 2025
Sotorasib + Panitumumab este fármaco 26.4% 5.6 Phase 3 / n=160 1 PMID 38657256 · 2024
Sotorasib + Panitumumab (Phase 3) este fármaco 26.4% 5.6 Phase 3 / n=160 1 PMID 37870968 · 2023
Sotorasib 960mg + Panitumumab este fármaco 30.2% 5.6 Phase 3 / n=53 1 PMID 37870968 · 2023
Sotorasib 960 mg + Panitumumab este fármaco 30.2% — 3 / n=53 1 PMID 40215429

Criterios de Elegibilidad

Criterios de inclusión:

  • Hombres o mujeres mayores o iguales a 18 años.
  • Malignidad localmente avanzada o metastásica con mutación KRAS p.G12C identificada mediante pruebas moleculares, confirmada por estudio patológico.

Criterios de exclusión:

  • Metástasis cerebrales activas procedentes de tumores no cerebrales.
  • Infarto de miocardio dentro de los 6 meses previos al día 1 del estudio.
  • Enfermedad del tracto gastrointestinal que impida la administración de medicamentos por vía oral.

Avísame de ensayos parecidos

Cuando se abra un ensayo nuevo en España para estos biomarcadores, te lo enviamos. Sin registro.

Solo usaremos tu email para estos avisos. Asociación CRC Warriors, sin ánimo de lucro. Privacidad

Información del Ensayo

NCT03600883
Completado
Fase 1
713 participantes
Ago 2018
May 2026

Ubicaciones133

Australia (4)
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Peter MacCallum Cancer Centre
Parkville, Victoria, 3050
Austria (5)
Medizinische Universitaet Graz
Graz, 8036
Medizinische Universitaet Innsbruck
Innsbruck, 6020
Universitaetsklinikum Krems
Krems, 3500
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
Belgium (9)
Institut Jules Bordet
Brussels, B-1070
Grand Hopital de Charleroi
Charleroi, 6000
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Ziekenhuis Oost-Limburg
Genk, 3600
Universitair Ziekenhuis Gent
Ghent, 9000
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
Centre Hospitalier Universitaire de Liege
Liège, 4000
AZ Delta Campus Rumbeke
Roeselare, 8800
Brazil (6)
Instituto Coi
Rio de Janeiro, 20231-050
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000
Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer
Porto Alegre, Rio Grande do Sul, 90050-170
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Oncologia Rede D´Or
São Paulo, São Paulo, 04501-000
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050
Canada (6)
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, N6A 5W9
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
McGill University Health Centre Glen Site
Montreal, Quebec, H4A 3J1
France (6)
Institut Bergonie
Bordeaux, 33076
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Hopital de la Timone
Marseille, 13385
Institut Curie
Paris, 75005
Institut Claudius Regaud
Toulouse, 31059
Gustave Roussy
Villejuif, 94805
Germany (3)
Universitatsklinikum Koln
Cologne, 50937
Universitätsklinikum Essen
Essen, 45147
Klinikum der Universität München Campus Grosshadern
München, 81377
Greece (5)
Henry Dunant Hospital Center
Athens, 11526
Metropolitan Hospital
Athens, 18547
University Hospital of Heraklion
Heraklion - Crete, 71500
Agios Loukas Clinic
Thessaloniki, 55236
Theagenion Cancer Hospital
Thessaloniki, 54007
Hungary (6)
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121
Semmelweis Egyetem
Budapest, 1083
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
Szent Borbala Korhaz
Tatabánya, 2800
Tudogyogyintezet Torokbalint
Törökbálint, 2045
Japan (15)
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
St Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Portugal (5)
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
Lisbon, 1769-001
Fundacao Champalimaud
Lisbon, 1400-038
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
Porto, 4099-001
Hospital Cuf porto
Porto, 4100-180
Romania (8)
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest, 022328
Centrul de Radioterapie Amethyst Cluj
Cluj-Napoca, 407280
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015
SC Medisprof SRL
Cluj-Napoca, 400641
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200347
Institutul Regional de Oncologie Iasi
Iași, 700483
Spitalul Municipal Ploiesti
Ploieşti, 100337
SC Oncomed SRL
Timișoara, 300239
South Korea (7)
National Cancer Center
Goyang-si Gyeonggi-do, 10408
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Seoul National University Hospital
Seoul, 03080
Severance Hospital Yonsei University Health System
Seoul, 03722
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Spain (6)
Clinica Universidad de Navarra
Madrid, 28027
Fundacion Jimenez Diaz
Madrid, 28040
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Hospital Universitario Madrid Sanchinarro
Madrid, 28050
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Switzerland (3)
Universitaetsspital Basel
Basel, 4031
Hopitaux Universitaires de Geneve
Geneva, 1211
Universitaetsspital Zuerich
Zurich, 8091
United States (39)
City of Hope National Medical Center
Duarte, California, 91010
University of California Los Angeles
Los Angeles, California, 90095
University of California at SF
San Francisco, California, 94115
Sarcoma Oncology Research Center LLC
Santa Monica, California, 90403
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713
University of Florida Health
Gainesville, Florida, 32610
AdventHealth Orlando Infusion Center
Orlando, Florida, 32804
Moffitt Cancer Center
Tampa, Florida, 33612
Winship Cancer Institute
Atlanta, Georgia, 30322
Indiana University
Indianapolis, Indiana, 46202
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Michigan
Ann Arbor, Michigan, 48109
Henry Ford Health System
Detroit, Michigan, 48202
Washington University
St Louis, Missouri, 63110-1093
Roswell Park Cancer Institute
Buffalo, New York, 14263
Laura and Isaac Perlmutter Cancer Center at New York University Langone
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Duke University Medical Center, Morris Cancer Clinic
Durham, North Carolina, 27710
Cleveland Clinic
Cleveland, Ohio, 44195
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh, Pennsylvania, 15232
Gibbs Cancer Center and Research Institute - Spartanburg
Spartanburg, South Carolina, 29303
Vanderbilt University Ingram Cancer Center
Nashville, Tennessee, 37232
Texas Oncology - Austin Central
Austin, Texas, 78731
Texas Oncology - Baylor
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
US Oncology Research Investigational Products Center
Fairfax, Virginia, 22031
Virginia Cancer Specialists PC
Fairfax, Virginia, 22031
Blue Ridge Cancer Care
Salem, Virginia, 24153
Seattle Cancer Care Alliance
Seattle, Washington, 98109

Fuente Oficial

Ver en ClinicalTrials.gov