Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent 3 days on / 4 days off schedule to patients with advanced malignancies
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Oral administration twice daily in a 3 days on / 4 days off schedule. Starting dose will be 0.3 mg corresponding to approximately 0.005 mg/kg and dose will be escalated dependent on any dose limiting toxicities.
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Buffalo, New York, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Caen, France
Safety: Frequency of adverse events
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
Pharmacokinetics: Plasma concentrations of BAY1000394 will be measured. The following parameters will be calculated: Cmax, tmax, AUC(0-tn), AUC, and half-life.
Time frame: Approximately 6 weeks
Biomarkers evaluation: analysis of apoptosis marker CK18/M30 and total soluble cytokeratin CK18/M65
Time frame: Up to 3 years or longer if indicated
Assessment of expression (IHC) and amplification status (FISH) of markers related to cell proliferation and the cell cycle in Paraffin-embedded archival tumor samples. These will include, but may not be limited to Cyclin E, Cyclin D, p21, and Ki67
Time frame: From archival tumor blocks
Functional testing of peripheral leucocytes, for example induction of cytokine synthesis
Time frame: Approximately 6 weeks
Assessment of intracellular biomarkers of apoptosis (for example activated caspase 3, annexin V, expression of MCL 1 for patients with chronic lymphocytic leucemia only
Time frame: Approximately 6 weeks
Tumor response evaluation based on RECIST 1.1 (solid tumors) or response based on the pertinent guidelines (malignant lymphoma, chronic lymphocytic leukemia) every 2 cycles
Time frame: Up to 3 years or longer if indicated
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Lyon, France
Unnamed facility
Marseille, France
Unnamed facility
Villejuif, France
Unnamed facility
Heidelberg, Baden-Wurttemberg, Germany
Unnamed facility
Herne, North Rhine-Westphalia, Germany