ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Subjects With KRAS Wild-Type Metastatic Colorectal Cancer

Titre officiel

A Randomized, Multicentre, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer

Sommaire:

Le principal objectif de cette étude est de comparer l’effet du panitimumab à celui du cétuximab sur la survie globale dans le traitement du cancer colorectal métastatique réfractaire à la chimiothérapie chez des sujets porteurs de tumeurs exprimant le gène KRAS (virus du sarcome murin de Kirsten 2) de type sauvage.

Description de l'essai

Primary Outcome:

• To compare the effect of panitumumab versus cetuximab on overall survival for chemorefractory mCRC among subjects with wild-type KRAS tumours.

• To compare safety of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumours.
• To compare patient reported outcomes of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumours.
• To compare progression-free survival of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumours.
• To compare objective response rate of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumours.
• To compare time to response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumours.
• To compare time to treatment failure of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumours.
• To compare duration of response of panitumumab vs cetuximab for mCRC among subjects with wild-type KRAS tumours.

Voir cet essai sur ClinicalTrials.gov