Anetumab ravtansine thorough ECG and drug interaction study
Research type
Research Study
Full title
An open-label, Phase I study to assess the effect of itraconazole (CYP3A4 and P-gp inhibitor) on the pharmacokinetics of anetumab ravtansine and to assess the ECG effects, safety and immunogenicity of anetumab ravtansine given as a single agent and together with itraconazole in subjects with mesothelin-expressing advanced solid cancers.
IRAS ID
232157
Contact name
Dionysis Papadatos-Pastos
Contact email
Sponsor organisation
Bayer PLC
Eudract number
2017-001978-42
Duration of Study in the UK
1 years, 4 months, 27 days
Research summary
The purpose of this study is to assess the safety and effect anetumab ravtansine has on the electric activity of the heart, the effect of the body on the drug (pharmacokinetics), and immune response to the study drug (immunogenicity). When given either alone or in combination with another study drug, itraconazole, in patients with advanced solid cancers that have a protein called mesothelin on the tumour cell surface.
REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0376
Date of REC Opinion
24 Oct 2017
REC opinion
Further Information Favourable Opinion