The main purpose of the study is to establish a safe dose of AZD8055 in patients with mild or moderate liver disease by providing information on any potential side effects this drug may cause and collecting data about how hepatocellular carcinoma responds to the drug.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Dose escalation phase: Tablet taken orally, a single dose of AZD8055 on Day 1, followed by twice daily continuous dosing from Day 3 onwards, till discontinuation or withdrawal.Expansion phase: twice daily continuous dosing from Day 1 onwards till discontinuation or withdrawal.
Research Site
Hong Kong, Hong Kong
Research Site
Seongnam-si, Gyeonggi-do, South Korea
Research Site
Seoul, South Korea
Safety and tolerability (Adverse events, vital signs, ECG, chemistry, haematology, urinalysis, physical examination)
Time frame: Every week for Cycle 1 and 2, every 2 weeks from cycle 3 onwards, every 4 weeks from cycle 7 onwards
Evaluate the pharmacokinetics of AZD8055 following both single and multiple dosing
Time frame: Blood samples on 6 occasions during the first Cycle of the study (28 days)
To make a preliminary assessment of efficacy
Time frame: Every 4 weeks
To investigate the possible relationship between plasma concentration of AZD8055 concentrations and the extent of liver impairment.
Time frame: During Cycle 1 of the study - blood samples before study treatment and then on Day 1, 3, 10, 17, 24, 30 and then on day 1 of every cycle
Evaluate the change in Phosphorylation levels of certain biomarkers before and after treatment with AZD8055
Time frame: Blood samples x 3 times on Day 1 of the first cycle
To collect and store DNA for future exploratory research that may influence response to AZD8055
May not be reported in the CSR
Time frame: Blood sample on Day 1 or at any other visit during study
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