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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 ]

Measure Type Primary
Measure Title Time to Tumor Progression
Measure Description modified RECIST V1.0 was used
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  
Safety Issue No  

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

Measured Values
    ZD6474     PLACEBO  
Number of Participants Analyzed  
[units: participants]
  72     73  
Time to Tumor Progression  
[units: days]
Median ( 95% Confidence Interval )
  334  
  ( 232 to 421 )  
  176  
  ( 119 to 267 )  

No statistical analysis provided for Time to Tumor Progression



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

Measure Type Secondary
Measure Title Disease Control Rate at 6 Months
Measure Description number of participants that achieved disease control 6 months after randomisation. Best objective response of complete response + partial response + stable disease > 24 weeks according to RECIST criteria
Time Frame 6 months after randomisation  
Safety Issue No  

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

Measured Values
    ZD6474     PLACEBO  
Number of Participants Analyzed  
[units: participants]
  72     73  
Disease Control Rate at 6 Months  
[units: participants]
  41     31  

No statistical analysis provided for Disease Control Rate at 6 Months



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

Measure Type Secondary
Measure Title Objective Response Rate
Measure Description Best objective response of the participants from an average of 46.7 months, defined as complete or partial response according to RECIST criteria
Time Frame 46.7 months  
Safety Issue No  

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

Measured Values
    ZD6474     PLACEBO  
Number of Participants Analyzed  
[units: participants]
  72     73  
Objective Response Rate  
[units: participants]
  6     4  

No statistical analysis provided for Objective Response Rate



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

Measure Type Secondary
Measure Title Time to Death
Measure Description Interim analysistime to date of randomisation to date of death (data not mature at the time of this analysis, so number of deaths displayed instead.
Time Frame time from randomisation to date of death  
Safety Issue No  

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.
For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. For the safety part, 73 patients received at least one dose of ZD6474 and 72 placebo

Reporting Groups
  Description
ZD6474 ZD6474, Vandetanib 300mg
PLACEBO PLACEBO

Measured Values
    ZD6474     PLACEBO  
Number of Participants Analyzed  
[units: participants]
  72     73  
Time to Death  
[units: participants]
  19     21  

No statistical analysis provided for Time to 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00537095     History of Changes
Other Study ID Numbers: D4200C00079
Study First Received: September 27, 2007
Results First Received: April 27, 2011
Last Updated: January 9, 2013
Health Authority: Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Sweden: Medical Products Agency
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic