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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: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Renal Cell Carcinoma
 Drug: Cediranib
Drug: Cediranib Placebo
 Phase 2

Study Type: Interventional
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).


Enrollment: 62
Study Start Date: January 2007
Estimated Study Completion Date: June 2013
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Cediranib placebo
 Drug: Cediranib Placebo
oral tablet
Experimental: 2
Cediranib
 Drug: Cediranib
45 mg oral tablet
Other Names:
  • AZD2171
  • RECENTIN™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423332

Locations
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Groningen, Netherlands
Research Site
Leiden, Netherlands
Research Site
Nijmegen, Netherlands
United Kingdom
Research Site
Northwood, Middlesex, United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00423332     History of Changes
Other Study ID Numbers: D8480C00030, EudraCT no. 2006-002455-33
Study First Received: January 16, 2007
Results First Received: April 3, 2012
Last Updated: March 1, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:
cancer
tumour
advanced cancer
 Metastatic renal cell carcinoma
kidney cancer
RECENTIN

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013