Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
This is the first study where BAY1125976 is given to humans. Patients (all comers) will
receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine
the safety, tolerability and maximum tolerated dose (MTD) of BAY1125976. The relative
bioavailability of liquid service formulation and tablets will be determined.
After the MTD is defined breast cancer patients with and without AKT1 mutation will be
treated.
The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters
and tumor response of BAY1125976.
BAY1125976 will be given daily as single oral application. Treatment will be stopped if the
tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the
patient decides to exit treatment.