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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:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00537095
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;   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, 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
  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 
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) 
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
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Time Frame No text entered.
Additional Description For the efficacy part, 72 were randomized to received ZD6474 and 73 placebo. All 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

Serious Adverse Events
    ZD6474   PLACEBO
Total, serious adverse events     
# participants affected / at risk   19/73 (26.03%)   12/72 (16.67%) 
Blood and lymphatic system disorders     
Lymphadenopathy * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Cardiac disorders     
Angina pectoris * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Arrythmia * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Atrial fibrillation * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Atrioventricular block * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Bradyarrythmia † 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Sinus bradycardia * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Torsade de pointe * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Ventricular tachycardia * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Inguinal hernia * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Rectal haemorrhage * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Vomiting * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Infections and infestations     
Pneumonia * 1     
# participants affected / at risk   2/73 (2.74%)   1/72 (1.39%) 
Appendicitis * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Bronchopneumonia * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Urinary Tract infection viral * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Tibia fracture * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Investigations     
Electrocardiogramm QT prolonged * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Groin pain * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Muscular weakness * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Nervous system disorders     
Syncope * 1     
# participants affected / at risk   1/73 (1.37%)   1/72 (1.39%) 
Cerebral hemorrage * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Ischemic stroke * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Loss of conciousness * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Monoparesis * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1     
# participants affected / at risk   2/73 (2.74%)   0/72 (0.00%) 
Haemoptysis * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Interstitial lung disease * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Lung disorder * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Pleural effusion * 1     
# participants affected / at risk   0/73 (0.00%)   1/72 (1.39%) 
Skin and subcutaneous tissue disorders     
Cutaneous lupus erythematosus * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Photosensitivity reaction * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Rash * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Skin hemorrage * 1     
# participants affected / at risk   1/73 (1.37%)   0/72 (0.00%) 
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 12.1




  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-US@sanofi.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00537095     History of Changes
Other Study ID Numbers: D4200C00079
2007-001890-27 ( EudraCT Number )
LPS14940 ( Other Identifier: Sanofi )
Study First Received: September 27, 2007
Results First Received: April 27, 2011
Last Updated: October 7, 2016
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