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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.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: September 27, 2007
Last updated: October 7, 2016
Last verified: October 2016
Results First Received: April 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, 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, 145 patients were randomized by 16 centers in 7 European countries 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
ZD6474 ZD6474, Vandetanib 300mg

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

Baseline Measures
   ZD6474   PLACEBO   Total 
Overall Participants Analyzed 
[Units: Participants]
 72   73   145 
[Units: Year]
Mean (Standard Deviation)
 62.8  (11.21)   63.8  (11.59)   63  (11.4) 
[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

  Limitations and Caveats

  More Information