Phase 3 Multicenter, Randomized, Open-label, Active-contr... | EligiMed

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06252649Tipo: INTERVENTIONALInicio: 17 de jul de 2024Fin estimado: 31 de ago de 2031

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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

Intervenciones

drug

FOLFIRI Regimen

Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.

drug

Sotorasib

Immediate-release solid dosage form administered orally.

drug

Panitumumab

Administered via IV infusion Q2W.

drug

Bevacizumab-awwb

Administered via IV infusion Q2W.

Ubicaciones

Hospital Universitario Fundacion Favaloro

CABA, Buenos Aires, Argentina

RECRUITING

Instituto Argentino de Diagnóstico y Tratamiento

CABA, Buenos Aires, Argentina

RECRUITING

Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL

CABA, Buenos Aires, Argentina

RECRUITING

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Sanatorio Británico de Rosario

La Plata, Buenos Aires, Argentina

RECRUITING

Instituto de Investigaciones clinicas de Mar del Plata

Mar del Plata, Buenos Aires, Argentina

RECRUITING

Hospital Italiano de Córdoba

Córdoba, Córdoba Province, Argentina

RECRUITING

Sanatorio Allende

Córdoba, Córdoba Province, Argentina

RECRUITING

Clinica Universitaria Privada Reina Fabiola

Córdoba, Córdoba Province, Argentina

RECRUITING

Clinica Viedma

Viedma, Río Negro Province, Argentina

RECRUITING

Exelsus Oncologia Clinica

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

RECRUITING

Centro Oncologico Riojano Integral

La Rioja, Argentina

RECRUITING

Patrocinadores

PrincipalAmgen

Contactos

Amgen Call Center

CONTACT

medinfo@amgen.com 866-572-6436

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