drugset / Trial / NCT02824042

Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole

NCT02824042

Phase 1 Completed 63 enrolled Bayer
NaSingle-groupOpen-labelTreatment

Summary

Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers

Timeline

Start
2016-09-07
Primary completion
2018-06-27
Completion
2019-08-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Anetumab Ravtansine Monoclonal antibody 0.6 mg/kg Intravenous
Subject Anetumab Ravtansine Monoclonal antibody 6.5 mg/kg Intravenous
Subject Itraconazole Small molecule 200 mg Oral

Indications

No indication recorded.