Phase I dose escalation study for BAY 1238097
Research type
Research Study
Full title
An open-label, non-randomized, multicenter Phase I dose escalation study to characterize safety, tolerability, pharmacokinetics and maximum tolerated dose of BAY 1238097 in subjects with advanced malignancies
IRAS ID
167521
Contact name
Shahista Hussain
Contact email
Sponsor organisation
BayerHealthCare AG
Eudract number
2014-003131-19
Duration of Study in the UK
2 years, 0 months, 27 days
Research summary
The main purpose of the first part of this study is to identify the most appropriate dose of the study drug BAY 1238097 in terms of safety, tolerability (the effect of the drug on your body) and pharmacokinetics (the effect of your body on the drug). The highest dose of the drug that can be safely given will be identified.
The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.
The study is considered research because the study drug BAY 1238097 is under development and has not yet been approved for the treatment of cancer.REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0012
Date of REC Opinion
17 Feb 2015
REC opinion
Further Information Favourable Opinion