To investigate the safety and tolerability of AZD8055 intermittent dosing schedules when given orally to patients with advanced solid malignancies and lymphomas. Two intermittent dosing schedules will be explored with increasing doses until a maximum tolerated dose is determined for each schedule.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Oral tablet, single dose on Day 1, followed by a 48 hour - 7 day washout and then either twice daily alternate days dosing from multiple dose day 1 onwards or twice daily dosing for 21 days from multiple dose day 1 onwards followed by 7 days no treatment. Cycles of 28 days.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 5), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 6), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 7), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 8), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 9), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 10), although safety and tolerability parameters will be measured at all visits.
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Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 11), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 12), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 13), although safety and tolerability parameters will be measured at all visits.
Safety and tolerability of AZD8055; The number of patients with adverse events, including changes in vital signs, general organ function, clinical chemistry, haematology, urinalysis and physical examinations.
Time frame: Evaluability period is 5 weeks (visit 14), although safety and tolerability parameters will be measured at all visits.
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 2)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 3)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 4)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 6)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 7)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 8)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 9)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 10)
Evaluate the pharmacokinetics of AZD8055; Pharmacokinetic analysis of the plasma and urine concentration data for AZD8055 and its metabolites will be performed following both single and multiple dosing with two intermittent dosing schedules.
Time frame: 1 cycle (3-4 weeks, at visit 11)
Preliminary assessment of the anti-tumour activity of AZD8055; Evalution of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 and percentage change in tumour size and measurement of serological biomarkers.
Time frame: Every 2 cycles (at visits 1, 17, every subsequent 8 weeks, visit 100
Investigation of possible relationships between plasma AZD8055 concentrations / exposure and changes in safety parameters (including number and types of adverse events).
Time frame: 1 cycle (3-4 weeks, at visits 2, 3, 4, 6-11)