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.
Sponsor study identifier
Secondary identifiers
interventional
105
2 countries
8
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
October 2016
Actual (reported)Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 16, 2007
Actual (reported)January 18, 2007
Actual (reported)March 2008
Actual (reported)September 6, 2012
Actual (reported)October 2016
Actual (reported)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
Best Percentage Change From Baseline in Tumour Size During the Study
Treatment period up to Week 12 visit date for last patient in (LPI)
Duration of Response
Treatment period up to 2nd data cut-off of 8th March 2009
Progression Free Survival
Treatment period up to 2nd data cut-off of 8th March 2009.
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.
Best Objective Tumour Response
Baseline, Week 12 and every 8 weeks thereafter or until progression.
Cediranib placebo
Cediranib
45 mg oral tablet
oral tablet
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Site
Groningen, Netherlands
Research Site
Leiden, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Birmingham, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Northwood, United Kingdom
Mulders P, Hawkins R, Nathan P, de Jong I, Osanto S, Porfiri E, Protheroe A, van Herpen CM, Mookerjee B, Pike L, Jurgensmeier JM, Gore ME. Cediranib monotherapy in patients with advanced renal cell carcinoma: results of a randomised phase II study. Eur J Cancer. 2012 Mar;48(4):527-37. doi: 10.1016/j.ejca.2011.12.022. Epub 2012 Jan 28.
Jane Robertson
AstraZeneca
105 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2007
First Posted
January 18, 2007
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma
Contact the study team to confirm eligibility.
Research Site
Oxford, United Kingdom
Primary Completion
March 2008
Actual (reported)Study Completion
October 2016
Actual (reported)Last Updated
February 2, 2017
Results First Posted
September 6, 2012
Record last verified: 2016-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: