Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
45 mg oral tablet
oral tablet
Research Site
Groningen, Netherlands
Research Site
Leiden, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Birmingham, United Kingdom
Percentage Change From Baseline in Tumour Size at 12 Weeks
Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)\*100
Time frame: Baseline to Week 12
Best Percentage Change From Baseline in Tumour Size During the Study
Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions
Time frame: Treatment period up to Week 12 visit date for last patient in (LPI)
Duration of Response
Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.
Time frame: Treatment period up to 2nd data cut-off of 8th March 2009
Progression Free Survival
Number of months 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.
Time frame: Treatment period up to 2nd data cut-off of 8th March 2009.
Objective Tumour Response at 12 Weeks
Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD. At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.
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Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Northwood, United Kingdom
Research Site
Oxford, United Kingdom
Time frame: Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.
Best Objective Tumour Response
Best Objective Tumour response as defined by RECIST. Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as 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). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).
Time frame: Baseline, Week 12 and every 8 weeks thereafter or until progression.