Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
- Registration Number
- NCT00423332
- Lead Sponsor
- AstraZeneca
- Brief Summary
Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- Confirmation of metastatic or recurrent renal cell carcinoma
- Certain types of previous anti-cancer therapy for Renal Cell Carcinoma
- Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes
- Patients with a history of poorly controlled high blood pressure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Cediranib Placebo Cediranib placebo 2 Cediranib Cediranib
- Primary Outcome Measures
Name Time Method Percentage Change From Baseline in Tumour Size at 12 Weeks Baseline to Week 12 Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)\*100
- Secondary Outcome Measures
Name Time Method Best Percentage Change From Baseline in Tumour Size During the Study Treatment period up to Week 12 visit date for last patient in (LPI) Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions
Duration of Response Treatment period up to 2nd data cut-off of 8th March 2009 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.
Progression Free Survival Treatment period up to 2nd data cut-off of 8th March 2009. 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.
Objective Tumour Response at 12 Weeks 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. 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.
Best Objective Tumour Response Baseline, Week 12 and every 8 weeks thereafter or until progression. 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).
Trial Locations
- Locations (1)
Research Site
🇬🇧Oxford, United Kingdom