drugset / Trial / NCT01008475
EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |