The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00243347
First received: October 21, 2005
Last updated: August 9, 2013
Last verified: August 2013
Results First Received: March 22, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Carcinoma
Non-Small-Cell Lung Carcinoma
Head and Neck Neoplasms
Intervention: Drug: AZD2171

  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
No text entered.

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
Cediranib 30 mg Cediranib 30mg/Day

Participant Flow:   Overall Study
    Cediranib 30 mg  
STARTED     19 [1]
COMPLETED     0 [2]
NOT COMPLETED     19  
Lack of Efficacy                 4  
Adverse Event                 2  
Death                 1  
Withdrawal by Subject                 5  
Condition worsened                 7  
[1] Treated
[2] Completed study



  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
Cediranib 30 mg Cediranib 30mg/Day

Baseline Measures
    Cediranib 30 mg  
Number of Participants  
[units: participants]
  19  
Age  
[units: Years]
Mean ± Standard Deviation
  58.1  ± 12.32  
Gender  
[units: Participants]
 
Female     4  
Male     15  



  Outcome Measures
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1.  Primary:   Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)   [ Time Frame: Randomisation until Day 22 ]

2.  Secondary:   Change From Baseline in Mean Arterial Blood Pressure (MAP)   [ Time Frame: Randomisation until Day 22 ]
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Measure Type Secondary
Measure Title Change From Baseline in Mean Arterial Blood Pressure (MAP)
Measure Description Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 – MAP value at baseline).
Time Frame Randomisation until Day 22  
Safety Issue No  

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.
Of the 19 patients, only 17 patients were evaluable MAP analysis. To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit.

Reporting Groups
  Description
Cediranib 30 mg Cediranib 30mg/Day

Measured Values
    Cediranib 30 mg  
Number of Participants Analyzed  
[units: participants]
  17  
Change From Baseline in Mean Arterial Blood Pressure (MAP)  
[units: mmHg]
Mean ( 95% Confidence Interval )
  6.853  
  ( 1.010 to 12.696 )  

No statistical analysis provided for Change From Baseline in Mean Arterial Blood Pressure (MAP)




  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


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00243347     History of Changes
Other Study ID Numbers: D8480C00015
Study First Received: October 21, 2005
Results First Received: March 22, 2013
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration