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

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. Identifier: NCT00537095
Recruitment Status : Active, not recruiting
First Posted : September 28, 2007
Results First Posted : July 8, 2011
Last Update Posted : December 7, 2017
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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

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

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) 
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

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

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.

  More Information