drugset / Trial / NCT00848510

EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases

NCT00848510

Phase 1 Completed 41 enrolled Merck KGaA, Darmstadt, Germany
NaSingle-groupOpen-labelTreatment

Summary

This study is intended to test an experimental drug called EMD 525797 (Abituzumab). This drug is not yet approved for sale and has only been tested in a small number of people to date (prior to this study starting another research study was carried out involving 37 healthy volunteers receiving the study drug). Until more is known about this study drug, it can only be used in research studies. This research study is planned to answer important questions about how the study drug is tolerated and how it may work in subjects with ovarian and colorectal cancer which has spread to the liver (i.e. metastatic cancer). The Sponsor (Merck KGaA) of this study is developing the study drug.

Timeline

Start
2009-02
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Abituzumab Monoclonal antibody 250 mg Intravenous
Subject Abituzumab Monoclonal antibody 500 mg Intravenous
Subject Abituzumab Monoclonal antibody 1000 mg Intravenous
Subject Abituzumab Monoclonal antibody 1500 mg Intravenous

Indications