AZD2171 in Treating Patients With Refractory Metastatic Kidney Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303862
First received: March 15, 2006
Last updated: May 5, 2014
Last verified: January 2013
Results First Received: July 8, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions: Drug: cediranib maleate
Other: laboratory biomarker analysis

  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
Patients were enrolled between December, 2006 and July, 2007 at three institutions. The trial was terminated after 10 patients were enrolled due to insufficent accrual rate.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Cediranib Maleate) Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Cediranib Maleate)  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  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
Treatment (Cediranib Maleate) Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Cediranib Maleate)  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  63.8  ± 11.0  
Gender  
[units: participants]
 
Female     3  
Male     7  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Objective Response   [ Time Frame: Up to 6 weeks ]

2.  Secondary:   Performance of DCE_MRI   [ Time Frame: One month after initiating therapy ]

3.  Secondary:   KDR   [ Time Frame: Day 28 after initiation of therapy ]

4.  Secondary:   eNOS   [ Time Frame: Baseline (prior to therapy) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Theodore Karrison, PhD
Organization: University of Chicago
phone: 773-702-9326
e-mail: tkarrison@health.bsd.uchicago.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303862     History of Changes
Other Study ID Numbers: NCI-2012-02686, NCI-2012-02686, CDR0000460237, UCCRC-NCI-7111, NCI-7111, 14018A, 7111, P30CA014599, N01CM62201, N01CM62209
Study First Received: March 15, 2006
Results First Received: July 8, 2013
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration