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NCT04185883

Actividad de sotorasib en sujetos con tumores sólidos avanzados con mutación KRAS p.G12C (CodeBreak 101)

Activo, No Reclutando Fase 1

Descripción

Evaluar la seguridad y tolerabilidad de sotorasib administrado en regímenes experimentales en participantes 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.
  • Tumor maligno localmente avanzado o metastásico con mutación KRAS p.G12C, documentado por patología e identificado mediante pruebas moleculares realizadas de acuerdo con los requisitos del país. En los Estados Unidos, esta prueba debe realizarse en un laboratorio certificado por las Enmiendas de Mejora de los Laboratorios Clínicos (CLIA).

Criterios de exclusión:

  • Tumor cerebral primario.
  • Compresión de la médula espinal, o metástasis cerebrales no tratadas, sintomáticas o activas, o enfermedad leptomeningea procedente 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.

Información del Ensayo

NCT04185883
Activo, No Reclutando
Fase 1
610 participantes
Dic 2019
Dic 2026

Ubicaciones90

Australia (5)
Nepean Cancer Centre
Kingswood, New South Wales, 2747
GenesisCare -North Shore Oncology
St Leonards, New South Wales, 2065
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
St John of God Healthcare
Subiaco, Western Australia, 6008
Austria (2)
Medizinische Universitaet Graz
Graz, 8036
Landeskrankenhaus Salzburg
Salzburg, 5020
Belgium (2)
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Canada (1)
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, G1J 1Z4
Germany (4)
Charite Universitaetsmedizin Berlin, Campus Virchow
Berlin, 13353
Universitatsklinikum Koln
Cologne, 50937
Universitaetsklinikum Dresden
Dresden, 01307
Universitaetsklinikum Essen
Essen, 45147
Italy (3)
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, 37126
Japan (3)
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
Netherlands (1)
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
South Korea (3)
Asan Medical Center
Seoul, 138-736
Seoul National University Hospital
Seoul, 03080
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Spain (6)
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, 08908
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Taiwan (4)
National Cheng Kung University Hospital
Tainan, 70403
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, 33305
United Kingdom (1)
Sarah Cannon Research Institute UK
London, W1G 6AD
United States (55)
Arizona Oncology Associates Professional Corporation
Tucson, Arizona, 85711
City of Hope National Medical Center
Duarte, California, 91010
University of California San Diego Moores Cancer Center
La Jolla, California, 92093
Loma Linda University Cancer Center
Loma Linda, California, 92354
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of California Davis Medical Center
Sacramento, California, 95817
University of California San Francisco Mission Bay Campus
San Francisco, California, 94115
University of California Los Angeles
Santa Monica, California, 90404
Rocky Mountain Cancer Centers Denver Midtown
Denver, Colorado, 80218
Sarah Cannon Research Institute
Denver, Colorado, 80218
Yale New Haven Hospital
New Haven, Connecticut, 06520
Norwalk Hospital
Norwalk, Connecticut, 06856
Memorial Cancer Institute
Pembroke Pines, Florida, 33028
Moffitt Cancer Center
Tampa, Florida, 33612
Emory University
Atlanta, Georgia, 30322
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Indiana University
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Johns Hopkins University
Baltimore, Maryland, 21224
University of Michigan
Ann Arbor, Michigan, 48109-5912
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202
Washington University
St Louis, Missouri, 63110-1093
Roswell Park Cancer Institute
Buffalo, New York, 32224
Columbia University Irving Medical Center
New York, New York, 10032
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Montefiore Medical Center
The Bronx, New York, 10461
Levine Cancer Institute
Charlotte, North Carolina, 28204
Duke University
Durham, North Carolina, 27710
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Oregon Health and Science University
Portland, Oregon, 97239
Providence Portland Medical Center
Portland, Oregon, 97213
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Gibbs Cancer Center and Research Institute - Spartanburg
Spartanburg, South Carolina, 29303
Avera Cancer Institute
Sioux Falls, South Dakota, 57108
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Texas Oncology Central-South
Austin, Texas, 78705
Mary Crowley Cancer Research
Dallas, Texas, 75230
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Oncology Consultants
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
US Oncology Research Investigational Products Center
The Woodlands, Texas, 77380
Texas Oncology Northeast Texas
Tyler, Texas, 75702
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684

Fuente Oficial

Ver en ClinicalTrials.gov