Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Metastatic Colorectal Cancer
Спонсор: Amgen
Налично на:
БГ
Обобщение
The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.
Кой може да участва
Inclusion Criteria:
* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
* Central laboratory detection of KRAS p.G12C mutation.
* Measurable metastatic disease per RECIST v1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
* Adequate organ function.
Exclusion Criteria:
* Active, untreated brain metastases.
* Leptomeningeal disease
* Previous treatment with a KRAS p.G12C inhibitor
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan
Интервенции
FOLFIRI Regimen
DRUG
Sotorasib
DRUG
Panitumumab
DRUG
Bevacizumab-awwb
DRUG
Места на провеждане
286
Argentina (13)
Hospital Britanico de Buenos Aires
Buenos Aires
Hospital Universitario Fundacion Favaloro
CABA , Buenos Aires
Instituto Argentino de Diagnóstico y Tratamiento
CABA , Buenos Aires
Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL
CABA , Buenos Aires
Cemic
Ciudad Autonoma de Buenos Aires , Buenos Aires
Hospital Italiano de Córdoba
Córdoba , Córdoba Province
Sanatorio Allende
Córdoba , Córdoba Province
Clinica Universitaria Privada Reina Fabiola
Córdoba , Córdoba Province
Sanatorio Británico de Rosario
La Plata , Buenos Aires
Centro Oncologico Riojano Integral
La Rioja
Instituto de Investigaciones clinicas de Mar del Plata
Mar del Plata , Buenos Aires
Exelsus Oncologia Clinica
San Miguel de Tucumán , Tucumán Province
Clinica Viedma
Viedma , Río Negro Province
Австралия (6)
Flinders Medical Centre
Bedford Park , South Australia
Chris OBrien Lifehouse
Camperdown , New South Wales
Austin Health, Austin Hospital
Heidelberg , Victoria
Toowoomba Hospital
Toowoomba , Queensland
The Queen Elizabeth Hospital
Woodville South , South Australia
Princess Alexandra Hospital
Woolloongabba , Queensland
Австрия (5)
Medizinische Universitaet Graz
Graz
Ordensklinikum Linz Barmherzige Schwestern
Linz
Landeskrankenhaus Feldkirch
Rankweil
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna
Krankenhaus Wiener Neustadt
Wiener Neustadt
Белгия (8)
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
БГ
EN