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aflibercept · AFFIRM

Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

Ensayo de Sanofi en Colorectal Neoplasms · Neoplasm Metastasis (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

268

previstos

Centros

37

Fin del objetivo primario

abr 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en feb 2009.

Qué mide

Progression Free Survival (PFS) Rate at 12 Months (del registro, en inglés) (12 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study. Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept. This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints. Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.

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Ficha completa en ClinicalTrials.gov (NCT00851084), actualizada en may 2016.