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
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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
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.
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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 ]


  Serious Adverse Events


  Other Adverse Events


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