- This was the first study where BAY1163877 was given to humans. Impact of the study was
to evaluate if patients with advanced solid cancers show advanced clinical benefit under
the treatment with the pan FGFR inhibitor. Patients (all comers) received the study drug
treatment in a dose-escalation scheme (no placebo group) to determine the safety,
tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative
bioavailability of liquid service formulation and tablets was determined.
- After the MTD was defined patients with solid tumors (all comers), lung cancer (lung
adenocarcinoma & squamous non-small cell lung cancer), head and neck cancer or bladder
cancer was enrolled according to their FGFR expression profile (biomarker
stratification).
- The study also assessed the pharmacokinetics, biomarker status, pharmacodynamic
parameters and tumor response of BAY1163877.
- BAY1163877 was given twice daily as oral application. Treatment was stopped if the tumor
continued to grow, if side effects, which the patient cannot tolerate, occurred or if
the patient decided to exit treatment.