drugset / Trial / NCT01008475

EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer

NCT01008475

Phase 1/2 Completed 232 enrolled Merck KGaA, Darmstadt, Germany
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.

Timeline

Start
2009-10
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Abituzumab Monoclonal antibody 250 mg Intravenous
Subject Abituzumab Monoclonal antibody 500 mg Intravenous
Subject Abituzumab Monoclonal antibody 750 mg Intravenous
Subject Abituzumab Monoclonal antibody 1000 mg Intravenous
Background Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous

Indications