This study will be conducted as an open label, single centre, Phase I study of PI3K (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8 and Day 15 with three weeks on and one week off in each treatment cycle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
0.4mg/ kg, iv, day 1,8 and 15, every 28 days
0.8mg/ kg, iv, day 1,8 and 15, every 28 days
Unnamed facility
Kashiwa, Chiba, Japan
Number of subjects with adverse events
Time frame: 169 days
Maximum drug concentration in plasma after single dose administration (Cmax)
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
Cmax divided by dose (mg) per kg body weight (Cmax,norm)
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
Cmax divided by dose (mg) (Cmax/D)
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
Area under the concentration-time curve time 0 to 8 hours (AUC(0-8))
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15
Area under the concentration-time curve from time 0 to 25 hours (AUC(0-25))
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
AUC(0-25) divided by dose (mg) per kg body weight (AUC(0-25)norm)
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
AUC(0-25) divided by dose (mg) (AUC(0-25)/D)
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
AUC from time 0 to last data point (AUC(0-tlast))
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
Time to maximum drug concentration in plasma (tmax)
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Area under the plasma concentration-time curve of (AUC) of BAY80-6946
Time frame: 0 - 168 hours in Cycle1 Day1
Half-life associated with terminal slope of drug in plasma (t1/2)
Time frame: 0 - 168 hours in Cycle1 Day1
Mean residence time of drug in plasma (MRT)
Time frame: 0 - 168 hours in Cycle1 Day1
Total body clearance of drug from plasma (CL)
Time frame: 0 - 168 hours in Cycle1 Day1
Volume of drug distribution during terminal phase after single dose administration (Vz)
Time frame: 0 - 168 hours in Cycle1 Day1
Volume of drug distribution during steady state after single dose administration (Vss)
Time frame: 0 - 168 hours in Cycle1 Day1
Accumulation ratio calculated from AUC(0-8) after multiple dosing and AUC(0-8) after single dosing (RAAUC(0-8))
Time frame: 0 - 8 hours in Cycle3 Day15
Accumulation ratio calculated from AUC(0-25) after multiple dosing and AUC(0-25) after single dosing (RAAUC(0-25))
Time frame: 0 - 25 hours in Cycle1 Day15
Accumulation ration calculated from Cmax after multiple dosing and Cmax after single dosing (RACmax)
Time frame: 0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15
Overall tumor response rate
Proportion of subjects with confirmed complete and partial response
Time frame: 176 days
Overall disease control rate
Proportion of subjects who had a best response rating of complete response, partial response or stable disease
Time frame: 176 days
Time to progression of cancer growth
Time frame: 176 days
Progression-free survival time
Time frame: 176 days