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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00537095
First Posted: September 28, 2007
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
Results First Submitted: April 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Thyroid Neoplasms
Interventions: Drug: Vandetanib
Other: Placebo

  Participant Flow


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

Baseline Measures
   ZD6474   PLACEBO   Total 
Overall Participants Analyzed 
[Units: Participants]
 72   73   145 
Age 
[Units: Year]
Mean (Standard Deviation)
 62.8  (11.21)   63.8  (11.59)   63  (11.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      33  45.8%      34  46.6%      67  46.2% 
Male      39  54.2%      39  53.4%      78  53.8% 


  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


  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