Buscador de ensayos clínicos

" Volver a los resultados

Ver en ClinicalTrials.gov Exportar CSV

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Estado del programa

Reclutamiento

Fase

Fase 1

Inmunoterapia previa permitida

Sí

Ensayo dirigido por el CRC

Drogas

afatinib, AMG 404, Atezolizumab, carboplatin, pemetrexed, docetaxel, everolimus, FOLFIRI, FOLFOX, MVASI® (bevacizumab-awwb), palbociclib, panitumumab, Pembrolizumab, RMC-4630, Sotorasib, TNO155, Trametinib

Etiquetas

MSI-H/ MMRd, MSS/ MMRp

Comentarios

Combination of targeted-to-the-mutation therapy PLUS several other anti-cancer therapies (targeted therapies and chemotherapies, in the case of the arms of the trial that admit CRC patients).
AMG 510: targeted therapy against the KRAS G12C mutation.
Only key inclusion criteria listed in the trial record:
Having a locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
(NO mention of prior immunotherapy, prior targeted therapy, measurable or just evaluable disease, how many lines of prior therapy required, etc.)
AMG 510 monotherapy: minimal activity in CRC (NCT03600883; see Helpful Links), hence the combinations tested in this trial.

Early data from this trial’s phase 1b dose exploration (n=8) and expansion (n=18) cohorts showed promising antitumor activity for the combination of Soto and panitumumab (Pmab) (see Helpful Links)

Enlaces útiles

https://www.annalsofoncology.org/article/S0923-7534(22)04268-5/fulltext

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

Contactos

Amgen Call Center
CONTACTO
866-572-6436 medinfo@amgen.com

Criterios de inclusión

Criterios de inclusión:

* Men or women greater than or equal to 18 years old.
* Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Criterios de exclusión

Criterios de exclusión:

* Primary brain tumor.
* Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
* Myocardial infarction within 6 months of study day 1.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.

NCT ID

NCT04185883

Fecha en que se añadió el juicio

2019-12-04

Fecha de actualización

2025-03-27