Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma

Study Overview
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Brief Summary
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Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.

Official Title
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A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib 45mg Versus Placebo Following 12 Weeks of Treatment in Patients With Metastatic or Recurrent Renal Cell Carcinoma Who Have Had no Previous Anti-VEGF Therapy.

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Cediranib
* Drug: Cediranib Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmation of metastatic or recurrent renal cell carcinoma Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Cediranib placebo | Drug: Cediranib Placebo<br>* oral tablet<br>|
| Experimental: 2<br>Cediranib | Drug: Cediranib<br>* 45 mg oral tablet<br>* Other names: RECENTIN™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 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). | Baseline, Week 12 and every 8 weeks thereafter or until progression. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, tumour, advanced cancer, Metastatic renal cell carcinoma, kidney cancer, RECENTIN