Clinical study to determine safety, tolerability, and maximum tolerated dose of BAY1000394 given in 4 week on / 2 week off schedule to patients with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
BAY1000394 will be administered orally twice a day (bid) in a 4 week on / 2 week off schedule.
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Chapel Hill, North Carolina, United States
Number of subjects with Adverse Events as a measure safety
Time frame: Up to 3 years or longer if indicated
Maximum tolerated dose: Measured by adverse event profile
Time frame: Up to 3 years or longer if indicated
Biomarkers evaluation measured by Enzyme-linked immunosorbent assay (ELISA)
Time frame: Up to 3 years or longer if indicated
Tumor Response evaluation measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: Up to 3 years or longer if indicated
Peak Plasma Concentration (Cmax) of BAY1000394
Time frame: Approximately 18 months
Pharmacokinetics parameters will be measured using Peak Plasma Time (tmax) of BAY1000394
Time frame: Approximately 18 months
Area under the plasma concentration versus time curve from 0 to tn (AUC(0 tn)) of BAY1000394
Time frame: Approximately 18 months
Area under the plasma concentration versus time curve (AUC) of BAY1000394
Time frame: Approximately 18 months
Half-life of BAY1000394
Time frame: Approximately 18 months
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