The purpose of this study is to characterize the safety and tolerability of repeat doses of compound GSK2110183 in subjects with hematologic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
73
Starting Dose = 25mg once daily with dose escalation until unacceptable toxicity develops
Prince of Wales Hospital
Sydney, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Princess Margaret Hospital
Toronto, Ontario, Canada
Seoul National University Hospital
Seoul, South Korea
Physical exam
Time frame: Screening, Days -3, 8, At the start of each additional Cycle
Electrocardiogram (ECG)
Time frame: Days -3, -2, -1, 8, 15, At the start of each additional Cycle
Vital signs
Time frame: Screening, Days -3, -2, -1, 8, 15, At the start of each additional Cycle
Transthoracic Echocardiogram (TTE)/Multiple Gated Acquisition (MUGA) Scans
Time frame: Screening, Additionally as needed
Clinical Laboratory assessments
Time frame: Screening, Days -3, 1, 8, 15, At the start of each additional Cycle
ECOG Peformance Status
Time frame: Screening, Days -3, 8, At the start of each additional Cycle
PK - Maximum observed plasma concentraion (Cmax)
Time frame: Days -3, -2, -1, 8, 15
PK - time to Cmax [tmax] (Maximum observed plasma concentration)
Time frame: Days -3, -2, -1, 8, 15
PK - Area under the plasma concentration-time curve (AUC(0-t))
Time frame: Days -3, -2, -1, 8, 15
PK - Apparent terminal phase elimination rate constant
Time frame: Days -3, -2, -1, 8, 15
PK - Apparent terminal phase half-life (t1/2)
Time frame: Days -3, -2, -1, 8, 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK - oral clearance (CL/F)
Time frame: Days -3, -2, -1, 8, 15
Metabolite Profiling
Time frame: Days -3, 8