A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04793958Tipo: INTERVENTIONALInicio: 24 de jun de 2021Fin estimado: 30 de ene de 2026

Traducción no disponible, mostrando original

Resumen

Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.

Criterios de exclusión

Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
Active brain metastasis

Intervenciones

drug

MRTX849

28 Day Cycle

biological

Cetuximab

28 Day Cycle

drug

mFOLFOX6 Regimen

* Fluorouracil * Oxaliplatin * Folinic acid

drug

FOLFIRI Regimen

* Fluorouracil * Irinotecan * Folinic acid

Ubicaciones

Local Institution - 010-434

Buenos Aires, Argentina

Local Institution - 010-431

Buenos Aires, Argentina

Local Institution - 010-432

CABA, Argentina

Local Institution - 010-430

La Rioja, Argentina

Local Institution - 010-448

Porto Alegre, Argentina

Local Institution - 010-433

Viedma, Argentina

Patrocinadores

PrincipalMirati Therapeutics Inc.

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