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Completed

NCT Number: NCT00423332

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

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

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cediranib

Drug

45 mg oral tablet

Other names: AZD2171, RECENTIN™

Cediranib Placebo

Drug

oral tablet

Primary outcomes

  1. Percentage Change From Baseline in Tumour Size at 12 Weeks

    Time frame: Baseline to Week 12

    Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100

Secondary outcomes

  1. 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)

    Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions

  2. Duration of Response

    Time frame: Treatment period up to 2nd data cut-off of 8th March 2009

    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.

  3. Progression Free Survival

    Time frame: Treatment period up to 2nd data cut-off of 8th March 2009.

    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.

  4. 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.

    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.

  5. Best Objective Tumour Response

    Time frame: Baseline, Week 12 and every 8 weeks thereafter or until progression.

    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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2016
First posted
Jan 18, 2007
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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