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

Tracking Information
First Submitted Date ICMJE	August 18, 2010
First Posted Date ICMJE	September 2, 2010
Last Update Posted Date	May 16, 2011
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 2, 2010)	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) ]
Original Primary Outcome Measures ICMJE; (submitted: September 1, 2010)	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. ]; 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) ]
Change History	Complete list of historical versions of study NCT01194193 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 1, 2010)	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) ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Preliminary Anti-tumour Activity of mTor Kinase Inhibitor in Advanced Tumours
Official Title ICMJE	A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of the m-Tor Kinase Inhibitor AZD8055 Using Intermittent Dosing Schedules in Patients With Advanced Solid Malignancies and Lymphomas
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Cancer; Advanced Solid Tumours; Lymphomas
Intervention ICMJE	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.
Study Arms	Experimental: 1; Intervention: Drug: AZD8055
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Withdrawn
Estimated Enrollment ICMJE; (submitted: September 1, 2010)	63
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01194193
Other Study ID Numbers ICMJE	D1600C00002
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	MSD, AstraZeneca
Study Sponsor ICMJE	AstraZeneca
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Ian Smith, MD AstraZeneca R&D
PRS Account	AstraZeneca
Verification Date	May 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP