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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00423332
First received: January 16, 2007
Last updated: February 24, 2014
Last verified: February 2014

January 16, 2007
February 24, 2014
January 2007
March 2008   (final data collection date for primary outcome measure)
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
To determine the efficacy of AZD2171 compared to the efficacy of placebo in patients with metastatic or recurrent renal cell carcinoma by comparing changes in tumour size after 12 weeks of therapy (or upon progression if this occurs before 12 weeks).
Complete list of historical versions of study NCT00423332 on ClinicalTrials.gov Archive Site
  • 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).
  • To determine the efficacy by measurement of RECIST data at 12 weeks
  • To determine PK parameters, safety and tolerability and effects on angiogenesis biomarkers
  • To collect blood and tumour samples for pharmacogenetics and angiogenesis biomarker levels.
Not Provided
Not Provided
 
Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Renal Cell Carcinoma
  • Drug: Cediranib
    45 mg oral tablet
    Other Names:
    • AZD2171
    • RECENTIN™
  • Drug: Cediranib Placebo
    oral tablet
  • Placebo Comparator: 1
    Cediranib placebo
    Intervention: Drug: Cediranib Placebo
  • Experimental: 2
    Cediranib
    Intervention: Drug: Cediranib
Mulders P, Hawkins R, Nathan P, de Jong I, Osanto S, Porfiri E, Protheroe A, van Herpen CM, Mookerjee B, Pike L, Jürgensmeier 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
June 2014
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
NCT00423332
D8480C00030, EudraCT no. 2006-002455-33
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Robertson AstraZeneca
AstraZeneca
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP