The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
45 mg oral dose
oral tablet dose escalation
Research Site
Glasgow, United Kingdom
Research Site
Headington, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Part A: Area Under Plasma Concentration-time Curve (AUC)
Area under plasma concentration-time curve from zero to infinity
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Maximum Plasma (Peak) Concentration (Cmax)
Maximum plasma drug concentration
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: AUC (0-t)
Area under the curve from time 0 to the last measureable time point
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Time to Peak or Maximum Concentration (Tmax)
Time to reach peak or maximum concentration or maximum response
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Terminal Phase Half-life (t1/2λz)
Terminal phase half-life
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part A: Apparent Total Body Clearance (CL/F)
Apparent total body clearance of drug from plasma
Time frame: Measurements were collected up to 168 hours (following single dosing).
Part B: Best Overall Response Rate (ORR)
Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions. Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression\[non-PD\])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions
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Time frame: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.
Part B: Progression-free Survival (PFS)
Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began). Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing non-target lesions.
Time frame: Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.