A Phase 1 interventional study of AZD8055 in Cancer, Advanced Solid Tumours and Lymphomas, sponsored by AstraZeneca. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-16.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 63 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: AZD8055
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.
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)
No study locations are listed for this record.
This study is withdrawn, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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