Preliminary Anti-tumour Activity of mTor Kinase Inhibitor in Advanced Tumours

• 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. ] [ Designated as safety issue: Yes ]
• 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. ] [ Designated as safety issue: Yes ]
• 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. ] [ Designated as safety issue: Yes ]
• 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. ] [ Designated as safety issue: Yes ]
• 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. ] [ Designated as safety issue: Yes ]
• 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. ] [ Designated as safety issue: Yes ]
• 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. ] [ Designated as safety issue: Yes ]
• 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. ] [ Designated as safety issue: Yes ]
• 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. ] [ Designated as safety issue: Yes ]
• 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. ] [ Designated as safety issue: Yes ]
• 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) ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]

• 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 to visit 14), although safety and tolerability parameters will be measured at all visits. ] [ Designated as safety issue: Yes ]
• 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 visits 2, 3, 4, 6-11) ] [ Designated as safety issue: No ]

• 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 ] [ Designated as safety issue: No ]
• 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) ] [ Designated as safety issue: No ]

• Cancer
• Advanced Solid Tumours
• Lymphomas

Inclusion Criteria:

• Histological or cytological confirmation of an advanced solid malignant tumour or lymphoma which is refactory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria)
• WHO performance status 0-2
• Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients

Exclusion Criteria:

• Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug.
• Any investigational agents or study drugs from a previous clinical study within 30 days, any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
• Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions