Phase I Dose Escalation and Expansion of Oral BAY 1143269 in Combination With Intravenous Docetaxel

Inclusion Criteria

• •Male or female subjects aged \> 18 years
• •Subjects must have histologically or cytologically confirmed locally advanced or metastatic solid tumors and must be refractory to any standard therapy, or have no standard therapy available, or have actively refused any standard therapy or, in the investigator's opinion, experimental treatment in this study is clinically and ethically acceptable for the subject.
• •Subjects must have at least 1 measurable or evaluable tumor lesion according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, version 1.1)
• •Subjects must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •Subjects must have a life expectancy of at least 12 weeks
• •Subjects must have adequate bone marrow function as assessed by the following: hemoglobin \>=9.0 g/dL or \>=5.6 mmol/L, absolute neutrophil count (ANC) \>=1.500/mm\^3 or \>=1.5 x 10\^9/L (CTCAE Grade \<=1), platelet count \>= 100000/mm\^3 or \>=100 x 10\^9/L
• •Subjects must have adequate kidney function, as assessed by the estimated glomerular filtration rate (eGFR) \>=60 mL/min per 1.73 m\*2 \[Common Terminology Criteria for Adverse Events(CTCAE Grade \<=1)\] calculated by the Modification of Diet in Renal Disease Study Group (MDRD) formula
• •Subjects must have adequate liver function assessed by: total bilirubin \<= 1.0 x upper limit of normal (ULN), aspartate aminotransferase (ALT) \<= 3.0 x ULN (CTCAE Grade \<=1) or, if receiving BAY1143269 in combination with IV docetaxel, AST and ALT \<=1.5 x ULN if concomitant with alkaline phosphatase increase \>2.5 x ULN
• •Subjects must have adequate coagulation as assessed by: international normalized ratio (INR) or prothrombin time (PT) \<=1.5 times ULN (CTCAE Grade \<=1), partial thromboplastin time (PTT) \<=1.5 x ULN (CTCAE Grade \<=1)
• •Women of reproductive potential must have a negative serum beta human chorionic gonadotropin (b-HCG) pregnancy test within 7 days before the first dose of study drug. Women of reproductive potential and men with female partners of childbearing potential must agree to consistently use highly effective contraception between signing the informed consent and 60 days after the last administration of study drug