Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00537095
First received: September 27, 2007
Last updated: January 9, 2013
Last verified: January 2013
Results First Received: April 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Thyroid Neoplasms
Interventions: Drug: Vandetanib
Other: 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
From September 28th, 2007 to October 16th, 2008, 164 patients were enrolled in the study by 16 centres with a main activity in thyroid cancer in 7 European countries. Among these 164 patients, 145 patients were randomised to receive vandetanib 300 mg once daily oral dose or placebo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The main reason for non-randomisation was non-respect of eligibility criteria

Reporting Groups
  Description
ZD6474 ZD6474, Vandetanib 300mg
PLACEBO PLACEBO

Participant Flow:   Overall Study
    ZD6474     PLACEBO  
STARTED     72     73  
COMPLETED     21     16  
NOT COMPLETED     51     57  
surgery                 1                 0  
Adverse Event                 24                 4  
disease progression                 21                 48  
Death                 3                 1  
Withdrawal by Subject                 2                 2  
subjective disease progression                 0                 1  
Incorrect enrolment                 0                 1  



  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
ZD6474 ZD6474, Vandetanib 300mg
PLACEBO PLACEBO
Total Total of all reporting groups

Baseline Measures
    ZD6474     PLACEBO     Total  
Number of Participants  
[units: participants]
  72     73     145  
Age  
[units: year]
Mean ± Standard Deviation
  62.8  ± 11.21     63.8  ± 11.59     63  ± 11.4  
Gender  
[units: Participants]
     
Female     33     34     67  
Male     39     39     78  



  Outcome Measures
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1.  Primary:   Time to Tumor Progression   [ Time Frame: Time from date of randomisation to date of the first documented tumor progression or date of death from any cause (within the 3 months) of tumor assessment ]

2.  Secondary:   Disease Control Rate at 6 Months   [ Time Frame: 6 months after randomisation ]

3.  Secondary:   Objective Response Rate   [ Time Frame: 46.7 months ]

4.  Secondary:   Time to Death   [ Time Frame: time from randomisation to date of death ]


  Serious Adverse Events


  Other Adverse Events


  More Information