Phase I trial of BAY 1251152 for advanced blood cancers
Research type
Research Study
Full title
An open-label, multicenter Phase I study to characterize the safety, tolerability, preliminary anti-tumor activity, pharmacokinetics and maximum tolerated dose of BAY 1251152 in patients with advanced hematological malignancies
IRAS ID
200672
Contact name
Oliver Ottmann
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2015-005122-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 21 days
Research summary
The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on haematological cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. 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.\nThe study will have 2 arms (AML and MM) and 2 study phases (a dose escalation phase and an expansion phase). Treatment is divided into cycles of 21 days with weekly infusion.
REC name
Wales REC 2
REC reference
16/WA/0066
Date of REC Opinion
24 Mar 2016
REC opinion
Further Information Favourable Opinion