Phase I study of oral BAY 1143269 given alone or in combination with intravenous docetaxel in subjects with advanced solid tumors
Research type
Research Study
Full title
An open-label, non-randomized, multicenter Phase I study to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of oral MKNK1 inhibitor BAY 1143269 given alone or in combination with intravenous docetaxel in subjects with advanced solid tumors
IRAS ID
178348
Contact name
Johann deBono
Contact email
Sponsor organisation
Bayer HealthCare Pharmaceuticals Inc.
Eudract number
2014-004810-27
Duration of Study in the UK
2 years, 2 months, 28 days
Research summary
BAY 1143269 is an MKNK1 Inhibitor and MKNK1 functions in helping tumor cells grow and survive under stress .Therefore, the interference of MKNK1 activity, by the addition of BAY 1143269, may provide a useful anticancer approach. This is a first –in human (Phase 1) study to characterize the safety and tolerability of oral BAY 1143269 when given alone or in combination with IV docetaxel in patients with advanced solid tumors. The effect of BAY 1143269 on the body and any anti-tumor activity will also be studied. All patients will receive BAY 1143269, some patients will also receive docetaxel, depending on the part of the study they enter,patients will only enter one part. The study is planned to start in one UK and 3 US sites and will involve male/ female adult patients, with advanced solid tumours. Further sites may be added during the study.
The study will consist of 3 parts:
• Dose escalation of oral BAY 1143269 given alone to determine the MTD (maximum tolerated dose) and the preliminary clinical antitumor activity of oral BAY 1143269 given alone in patients with advanced solid tumors . Up to 60 patients may be included in up to 10 cohorts in this part of the study.
• MTD expansion cohort with oral BAY 1143269 given alone daily or at another frequency, in patients with advanced non- small cell lung cancer (NSCLC). Approximately 20 patients will be enrolled in this cohort and it may start only after the MTD of BAY 1143269 given alone has been declared.
• Dose escalation/de-escalation with BAY 1143269 and docetaxel in patients who must have unresectable, locally advanced, or metastatic recurrent NSCLC eligible for docetaxel therapy and also no longer responding to docetaxel .Up to 24 patients may be included in up to 4 cohorts in this part of the study. Samples of blood and tissue are collected during the study for specialist laboratory measurements, which includes studying the effects of the study drug on the body and the effects of the body on the drug.
The study will also measure some biological markers (markers of biological activity in the patients 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 1143269 is under development and has not yet been approved for the treatment of cancer.REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/1016
Date of REC Opinion
23 Jul 2015
REC opinion
Further Information Favourable Opinion