drugset / Trial / NCT01047059

Molecular Imaging With Erlotinib and Bevacizumab

NCT01047059 ↗

Phase 2 Completed 40 enrolled University of Cologne
NaSingle-groupOpen-labelTreatment

Summary

The patients will be treated with erlotinib and bevacizumab for a six-week period. Imaging procedures will be performed at baseline, after one week of therapy and after the six weeks of treatment. The combination of erlotinib and bevacizumab represents an effective therapeutic strategy in NSCLC with the highest response rates ever reported for relapsed NSCLC having been observed recently in a phase II trial. Early differentiation of patients profiting and of patients not profiting from this therapy is of major relevance for further improving this targeted therapy approach and to develop more effective, personalized treatment strategies. We aim at this early identification by the combination of molecular and functional imaging tools (FDG-, FLT-PET, DCE-MRI), molecular marker analyses in tissue and peripheral blood (EGFR- and KRAS mutational status and high throughput mutational profiling in tumor tissue, angiogenesis-associated biomarkers and expression profiling in peripheral blood) and pharmokokinetic analyses. From the combined analyses of these tools we expect a better understanding of the host-drug interaction as a precondition for further improvement of erlotinib-bevacizumab combination therapy in NSCLC

Timeline

Start
2010-01
Primary completion
2012-10
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Erlotinib Small molecule 150 mg Oral