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NCT06252649
Estudio de sotorasib, panitumumab y FOLFIRI frente a FOLFIRI con o sin bevacizumab en participantes con cáncer colorrectal metastásico con mutación KRAS p.G12C que no han recibido tratamiento previo.
Reclutando
Fase 3
Descripción
El objetivo de este estudio es comparar la supervivencia libre de progresión (SLP) en participantes sin tratamiento previo que presenten cáncer colorrectal metastásico (CCm) con mutación KRAS p.G12C, que reciban sotorasib, panitumumab y FOLFIRI, en comparación con FOLFIRI con o sin bevacizumab-awwb.
Criterios de Elegibilidad
Criterios de inclusión:
- Adenocarcinoma colorrectal metastásico con mutación KRAS p.G12C documentada por patología mediante un ensayo validado localmente.
- Detección de la mutación KRAS p.G12C en el laboratorio central.
- Enfermedad metastásica medible según los criterios RECIST v1.1.
- Índice de rendimiento del Grupo de Oncología Cooperativa del Este (ECOG) de ≤ 1.
- Función orgánica adecuada.
Criterios de exclusión:
- Metástasis cerebrales activas no tratadas.
- Enfermedad leptomeningea.
- Tratamiento previo con un inhibidor de KRAS p.G12C.
- Antecedentes de neumonitis intersticial o fibrosis pulmonar o evidencia de neumonitis intersticial o fibrosis pulmonar en la tomografía computarizada basal.
Información del Ensayo
NCT06252649
Reclutando
Fase 3
450 participantes
Jul 2024
Sep 2028
Ubicaciones290
Argentina (13)
Hospital Britanico de Buenos Aires
Buenos Aires
Hospital Universitario Fundacion Favaloro
CABA
Instituto Argentino de Diagnóstico y Tratamiento
CABA
Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL
CABA
Cemic
Ciudad Autonoma de Buenos Aires
Clinica Universitaria Privada Reina Fabiola
Córdoba
Hospital Italiano de Córdoba
Córdoba
Sanatorio Allende
Córdoba
Sanatorio Británico de Rosario
La Plata
Centro Oncologico Riojano Integral
La Rioja
Instituto de Investigaciones clinicas de Mar del Plata
Mar del Plata
Exelsus Oncologia Clinica
San Miguel de Tucumán
Clinica Viedma
Viedma
Australia (6)
Flinders Medical Centre
Bedford Park
Chris OBrien Lifehouse
Camperdown
Austin Health, Austin Hospital
Heidelberg
Toowoomba Hospital
Toowoomba
The Queen Elizabeth Hospital
Woodville South
Princess Alexandra Hospital
Woolloongabba
Austria (5)
Medizinische Universitaet Graz
Graz
Ordensklinikum Linz Barmherzige Schwestern
Linz
Landeskrankenhaus Feldkirch
Rankweil
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna
Krankenhaus Wiener Neustadt
Wiener Neustadt
Belgium (8)
Institut Jules Bordet
Brussels
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels
Grand Hôpital de Charleroi - Site des Viviers
Charleroi
Universitair Ziekenhuis Gent
Ghent
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven
Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
Mechelen
AZ Delta Campus Rumbeke
Roeselare
Vitaz campus Sint-Niklaas Moerland
Sint-Niklaas
Brazil (16)
Fundacao pio xII Barretos
Barretos
Oncoclinicas Belo Horizonte
Barretos
Hospital Sirio Libanes Brasilia
Brasília
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí
Clinica de Neoplasias Litoral
Itajaí
Liga Norte-Riograndense Contra O Cancer
Natal
Associação Hospitalar Moinhos de Vento
Porto Alegre
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto
Fundacao Antonio Prudente AC Camargo Cancer Center
São Paulo
Instituto Brasileiro de Controle do Cancer Ibcc
São Paulo
Instituto Cancer Sao Paulo Icesp
São Paulo
Oncologia Rede D Or
São Paulo
Vencer e Oncoclinica
Teresina
Bulgaria (5)
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo
Complex Oncology Center Plovdiv EOOD
Plovdiv
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia
Multiprofile Hospital for Active Treatment Serdikamed EOOD
Sofia
Canada (6)
William Osler Health System - Brampton Civic Hospital
Brampton
Arthur J E Child Comprehensive Cancer Centre
Calgary
Allan Blair Cancer Centre
Regina
Saskatoon Cancer Centre
Saskatoon
Mount Sinai Hospital
Toronto
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto
Chile (8)
Enroll SpA
Providencia
Biocinetic servicios medicos limitada
Santiago
Centro de oncologia de precision Spa
Santiago
Fundacion Arturo Lopez Perez
Santiago
Centro de investigacion y desarrollo oncolgico Spa
Temuco
James Lind Centro de Investigacion del Cancer
Temuco
Clinical Research Chile SpA
Valdivia
Clinica Redsalud Vitacura, Instituto del Cancer
Vitacura
Colombia (6)
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
Bogotá
Instituto Nacional de Cancerologia
Bogota
Fundacion Oftalmologica de Santander - Foscal
Floridablanca
Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales
Medellín
Instituto Medico de Alta Tecnologia sas - Imat sas
Montería
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
Rionegro
Czechia (6)
Masarykuv onkologicky ustav
Brno
Fakultni nemocnice Hradec Kralove
Hradec Králové
Fakultni nemocnice Olomouc
Olomouc
Fakultni nemocnice Bulovka
Prague
Fakultni nemocnice Kralovske Vinohrady
Prague
Fakultni nemocnice v Motole
Prague
Denmark (4)
Aalborg Sygehus
Aalborg
Aarhus University Hospital
Aarhus N
Rigshospitalet
Copenhagen
Odense University Hospital
Odense C
Estonia (1)
North Estonia Medical Centre Foundation
Tallinn
France (16)
Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing
Clermont-Ferrand
Hopital Henri Mondor
Créteil
Centre Hospitalier Universitaire de Dijon - Hopital du Bocage
Dijon
Hopital Prive Jean Mermoz
Lyon
Institut regional du Cancer Montpellier
Montpellier
Centre Antoine Lacassagne
Nice
Hopital Europeen Georges Pompidou
Paris
Hopital Pitie-Salpetriere
Paris
Hopital Saint Louis
Paris
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac
Centre Hospitalier Universitaire de Poitiers
Poitiers
Hopital Robert Debre
Reims
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes
Institut de Cancerologie de l Ouest Rene Gauducheau
Saint-Herblain
Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy
Germany (10)
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin
Klinikum Chemnitz gGmbH
Chemnitz
Universitaetsklinikum Dresden
Dresden
Universitaetsklinikum Essen
Essen
UCT Universitaeres Zentrum fuer Tumorerkrankungen Frankfurt
Frankfurt am Main
Haematologisch Onkologische Praxis Eppendorf
Hamburg
Regional Kliniken Holding Klinikum Ludwigsburg
Ludwigsburg
Klinikum der LMU Muenchen
München
Universitaetsklinikum Ulm
Ulm
Klinikum der Stadt Wolfsburg
Wolfsburg
Greece (12)
Agios Savvas Anticancer Hospital
Athens
Aretaieio Hospital
Athens
Athens Medical Center S.A - Psychikon
Athens
General Hospital Evangelismos
Athens
Hygeia Hospital
Athens
Metropolitan Hospital
Athens
University Hospital of Larissa
Larissa
Metaxa Anticancer Hospital
Piraeus
Bioclinic of Thessaloniki
Thessaloniki
European Interbalkan Medical Center
Thessaloniki
Saint Luke Hospital
Thessaloniki
Saint Lukes Hospital SA
Thessaloniki
Hong Kong (3)
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Princess Margaret Hospital
Kowloon
Tuen Mun Hospital
New Territories
Hungary (6)
Orszagos Onkologiai Intezet
Budapest
Debreceni Egyetem Klinikai Kozpont
Debrecen
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyíregyháza
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok
Italy (19)
Istituto Ospedaliero Fondazione Poliambulanza
Brescia
Ente Ospedaliero IRCCS Saverio De Bellis
Castellana Grotte
Azienda Ospedaliero Universitaria Careggi
Florence
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia
Ospedale Policlinico San Martino IRCCS
Genova
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola FC
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
Naples
Istituto Nazionale dei Tumori IRCCS Fondazione Giovanni Pascale
Naples
Istituto Oncologico Veneto IRCCS
Padova
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo
Azienda Sanitaria Territoriale Pesaro Urbino - Presidio San Salvatore Muraglia
Pesaro
Azienda Ospedaliero Universitaria Pisana
Pisa
Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna
Ravenna
IRCCS Istituto Clinico Humanitas
Rozzano MI
Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
Udine
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
Verona
Japan (21)
Hyogo Cancer Center
Akashi-shi
Nippon Medical School Hospital
Bunkyo-ku
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku
Chiba Cancer Center
Chiba
National Cancer Center Hospital
Chuo-ku
National Hospital Organization Kyushu Cancer Center
Fukuoka
Kansai Medical University Hospital
Hirakata-shi
National Cancer Center Hospital East
Kashiwa-shi
St Marianna University Hospital
Kawasaki-shi
Saitama Cancer Center
Kitaadachi-gun
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku
National Hospital Organization Shikoku Cancer Center
Matsuyama
Aichi Cancer Center
Nagoya
Niigata Cancer Center Hospital
Niigata
National Hospital Organization Osaka National Hospital
Osaka
Hokkaido University Hospital
Sapporo
The University of Osaka Hospital
Suita-shi
Shizuoka Cancer Center
Sunto-gun
Tokushima University Hospital
Tokushima
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama
Yokohama City University Medical Center
Yokohama
Mexico (4)
Centro Especializado en Investigacion y Tratamiento Oncologicos SC
Benito Juárez
Health Pharma Professional Research SA de CV
Mexico City
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey
Netherlands (6)
Nederlands Kanker Instituut - Antoni van Leeuwenhoek
Amsterdam
Albert Schweitzer Ziekenhuis, Locatie Dordwijk
Dordrecht
Medisch Spectrum Twente
Enschede
Martini Ziekenhuis
Groningen
Maastricht Universitair Medisch Centrum
Maastricht
Universitair Medisch Centrum Utrecht
Utrecht
Poland (8)
Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
Gdynia
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
Kielce
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz
SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
Opole
Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
Poznan
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy
Warsaw
Portugal (9)
Unidade Local de Saude de Almada-Seixal, EPE - Hospital Garcia de Orta
Almada
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
Coimbra
Unidade Local de Saude de Coimbra, EPE
Coimbra
Fundacao Champalimaud
Lisbon
Hospital Cuf Tejo
Lisbon
Hospital da Luz, SA
Lisbon
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality
Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao
Santa Maria da Feira
Romania (7)
Institutul Clinic Fundeni
Bucharest
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
Bucharest
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca
Centrul de Oncologie Sf Nectarie SRL
Craiova
Institutul Regional de Oncologie Iasi
Iași
Spitalul Municipal Ploiesti
Ploieşti
SC Oncomed SRL
Timișoara
Slovakia (1)
Vychodoslovensky onkologicky ustav, as
Košice
South Korea (8)
National Cancer Center
Goyang-si, Gyeonggi-do
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
The Catholic University of Korea Seoul St Marys Hospital
Seoul
Spain (20)
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitari Vall d Hebron
Barcelona
Hospital Universitario de Burgos
Burgos
Hospital Universitario Reina Sofia
Córdoba
Hospital General Universitario de Elche
Elche
Hospital Universitario Virgen de las Nieves
Granada
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Hospital Regional Universitario de Malaga
Málaga
Complexo Hospitalario Universitario de Ourense
Ourense
Hospital Universitario Central de Asturias
Oviedo
Hospital Universitario de Navarra
Pamplona
Hospital Universitario Marques de Valdecilla
Santander
Hospital Universitario Virgen del Rocio
Seville
Hospital Clinico Universitario de Valencia
Valencia
Hospital General Universitario de Valencia
Valencia
Hospital Universitario Miguel Servet
Zaragoza
Sweden (1)
Soedersjukhuset
Stockholm
Switzerland (1)
Universitaetsspital Zuerich
Zurich
Taiwan (4)
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Taipei Veterans General Hospital
Taipei
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan
Thailand (1)
Siriraj Hospital
Bangkok
Turkey (Türkiye) (13)
Adana Sehir Egitim ve Arastirma Hastanesi
Adana
Ankara Bilkent Sehir Hastanesi
Ankara
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edirne
Acibadem Altunizade Hastanesi
Istanbul
Bagcilar Medipol Mega Universite Hastanesi
Istanbul
Bezmialem Vakif Universitesi Hastanesi
Istanbul
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Istanbul
Ege Universitesi Tip Fakultesi Hastanesi
Izmir
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
Konya
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya
United Kingdom (10)
Queen Elizabeth Hospital Birmingham
Birmingham
Beatson West of Scotland Cancer Centre
Glasgow
Guys Hospital
London
Royal Free Hospital
London
Royal Marsden Hospital
London
Sarah Cannon Research Institute UK
London
Maidstone Hospital
Maidstone
Mount Vernon Cancer Centre
Northwood
Weston Park Hospital
Sheffield
Royal Marsden Hospital - Sutton
Sutton
United States (26)
Georgia Cancer Specialists
Atlanta
Saint Louis Cancer Care West County
Bridgeton
Ironwood Cancer and Research Centers Scottsdale
Chandler
Insight Research Institute
Chicago
Henry Ford Health System
Detroit
Duke Cancer Center
Durham
Providence Saint Jude Medical Center
Fullerton
Cancer and Hematology Centers of Western Michigan
Grand Rapids
Hope and Healing Cancer Services
Hinsdale
Cancer Specialists of North Florida - Southpoint
Jacksonville
City of Hope National Medical Center
Long Beach
Cancer and Blood Research Center, LLC
Los Alamitos
California Research Institute
Los Angeles
D and H Cancer Research Center
Margate
Minniti Center for Medical Oncology and Hematology
Mickleton
Tennessee Oncology PLLC - Chattanooga
Nashville
Tennessee Oncology, PLLC
Nashville
Vanderbilt University Medical Center
Nashville
Norwalk Hospital
Norwalk
Mid Florida Hematology and Oncology Centers PA
Orange City
Thomas Jefferson University
Philadelphia
Pikeville Medical Center
Pikeville
FirstHealth Cancer Center
Pinehurst
Boca Raton Clinical Research Medical Center Inc
Plantation
Carolina Blood and Cancer Care
Rock Hill
Orchard Healthcare Research Inc
Skokie