The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents. The purpose of this study Part B is: Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Unnamed facility
Fayetteville, Arkansas, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Ann Arbor, Michigan, United States
Unnamed facility
Hackensack, New Jersey, United States
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 2 years
Maximum tolerated dose (MTD) of BAY1143572
In Part A: Maximum tolerated dose (MTD) of BAY1143572 In Part B; Maximum tolerated dose ( MTD) with G-CSF of BAY114357 The MTD is defined as the highest dose that can be given such that not more than 20% of subjects experience a dose limiting toxicity (DLT) during cycle 1.
Time frame: Up to 1 year
Maximum total drug concentration (Cmax)
Time frame: Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)
Time frame: Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to infinity (AUC)
Time frame: Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
Time of maximum observed concentration (tmax)
Time frame: Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
Tumor response based on RECIST 1.1 or Cheson 2007 criteria
Time frame: Up to 100 weeks
Biomarker evaluation by determination of MYC protein expression and PCNA mRNA
PCNA: proliferating cell nuclear Antigen mRNA: messenger ribonucleic acid
Time frame: Cycle 1, Day 1, Day 8 and Day 15 (each cycle is 28 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
New York, New York, United States
Unnamed facility
Charleston, South Carolina, United States
Unnamed facility
Singapore, Singapore
Unnamed facility
Singapore, Singapore
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
...and 2 more locations