Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: January 16, 2007
Last updated: December 10, 2013
Last verified: December 2013
Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Percentage Change From Baseline in Tumour Size at 12 Weeks [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]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:
- Best Percentage Change From Baseline in Tumour Size During the Study [ Time Frame: Treatment period up to Week 12 visit date for last patient in (LPI) ] [ Designated as safety issue: No ]Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions
- Duration of Response [ Time Frame: Treatment period up to 2nd data cut-off of 8th March 2009 ] [ Designated as safety issue: No ]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 [ Time Frame: Treatment period up to 2nd data cut-off of 8th March 2009. ] [ Designated as safety issue: No ]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 [ 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. ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, Week 12 and every 8 weeks thereafter or until progression. ] [ Designated as safety issue: No ]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).
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||June 2014|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Drug: Cediranib Placebo
45 mg oral tablet
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423332
|Northwood, Middlesex, United Kingdom|
|Birmingham, United Kingdom|
|London, United Kingdom|
|Manchester, United Kingdom|
|Oxford, United Kingdom|
Sponsors and Collaborators
|Study Director:||Jane Robertson||AstraZeneca|