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

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cediranib
Cediranib Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring cancer, tumour, advanced cancer, Metastatic renal cell carcinoma, kidney cancer, RECENTIN

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Cediranib placebo

Cediranib

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.
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).

Full Information

First Posted
January 16, 2007
Last Updated
December 8, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00423332
Brief Title
Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
cancer, tumour, advanced cancer, Metastatic renal cell carcinoma, kidney cancer, RECENTIN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Cediranib placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Cediranib
Intervention Type
Drug
Intervention Name(s)
Cediranib
Other Intervention Name(s)
AZD2171, RECENTIN™
Intervention Description
45 mg oral tablet
Intervention Type
Drug
Intervention Name(s)
Cediranib Placebo
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Percentage Change From Baseline in Tumour Size at 12 Weeks
Description
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
Secondary Outcome Measure Information:
Title
Best Percentage Change From Baseline in Tumour Size During the Study
Description
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)
Title
Duration of Response
Description
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
Title
Progression Free Survival
Description
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.
Title
Objective Tumour Response at 12 Weeks
Description
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.
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.
Title
Best Objective Tumour Response
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Robertson
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Leiden
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
Country
Netherlands
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Northwood
Country
United Kingdom
Facility Name
Research Site
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22285180
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=419&filename=CSR-D8480C00030.pdf
Description
CSR-D8480C00030.pdf

Learn more about this trial

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

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