drugset / Trial / NCT01919879

Dual Targeting of EGFR With Cetuximab and Afatinib to Treat Refractory wtKRAS Metastatic Colorectal Cancer

NCT01919879

Phase 2 Completed 75 enrolled UNICANCER
RandomizedCrossoverOpen-labelTreatment

Summary

This is a multicentric, phase II and open label study.75 patients are expected to be randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS metastatic colorectal cancer.

Timeline

Start
2012-10
Primary completion
2015-11
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 40 mg Oral
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous

Indications