drugset / Trial / NCT00503685

Study Using IMC-A12 (Cixutumumab) With or Without Cetuximab in Participants With Metastatic Colorectal Cancer Who Have Failed a Treatment Regimen That Consisted of a Prior Anti-EGFR Therapy

NCT00503685

Phase 2 Completed 65 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

Participants with metastatic Colorectal Cancer (mCRC) who have progressed on a prior Anti-epidermal growth factor receptor (EGFR) regimen randomized to receive IMC-A12 monotherapy or combination therapy with cetuximab to assess response, survival, durations of response, safety and tolerability as well as pharmacodynamics of IMC-A12 and cetuximab

Timeline

Start
2007-06
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Subject Cixutumumab Monoclonal antibody 10 mg/kg Intravenous

Indications