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
Results First Received: April 3, 2012  
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
Condition: Renal Cell Carcinoma
Interventions: Drug: Cediranib
Drug: Cediranib Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Seventy-one patients were randomised to study treatment: 53 to cediranib 45 mg and 18 to placebo. Following unblinding for the primary analysis, all patients, except those who had progressed on cediranib, then had the option of receiving open-label treatment with cediranib. Randomised=ITT=Safety set: Cediranib 45mg 53, Placebo 18.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AZD2171 45 mg AZD2171 45mg/Day: 53 patients randomised
Placebo Placebo / Day: 18 patients randomised

Participant Flow:   Overall Study
    AZD2171 45 mg     Placebo  
STARTED     53 [1]   18 [2]
Continuing After Unblinding     44 [3]   14 [3]
Ongoing at Data Cut Off (8th March 2009)     22 [4]   4 [4]
COMPLETED     44 [5]   11 [5]
NOT COMPLETED     9     7  
Adverse Event                 6                 2  
Withdrawal by Subject                 1                 0  
Condition under investigation worsened                 1                 1  
Progressive at Week 6                 0                 1  
Unblinded before 12 weeks                 1                 3  
[1] Randomised
[2] Number randomised
[3] Number starting/ continuing AZD2171 after unblinding
[4] Number ongoing at data cut off (8th March 2009)
[5] Number completing 12 weeks blinded randomised treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD2171 45 mg AZD2171 45mg/Day
Placebo Placebo/Day
Total Total of all reporting groups

Baseline Measures
    AZD2171 45 mg     Placebo     Total  
Number of Participants  
[units: participants]
  53     18     71  
Age [1]
[units: Years]
Mean ± Standard Deviation
  60.7  ± 7.7     62.4  ± 8.7     61.2  ± 7.9  
Gender [2]
[units: Participants]
     
Female     13     3     16  
Male     40     15     55  
[1] Age at informed consent
[2] Gender at informed consent



  Outcome Measures
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1.  Primary:   Percentage Change From Baseline in Tumour Size at 12 Weeks   [ Time Frame: Baseline to Week 12 ]

2.  Secondary:   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) ]

3.  Secondary:   Duration of Response   [ Time Frame: Treatment period up to 2nd data cut-off of 8th March 2009 ]

4.  Secondary:   Progression Free Survival   [ Time Frame: Treatment period up to 2nd data cut-off of 8th March 2009. ]

5.  Secondary:   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. ]

6.  Secondary:   Best Objective Tumour Response   [ Time Frame: Baseline, Week 12 and every 8 weeks thereafter or until progression. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

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: February 24, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)