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

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ClinicalTrials.gov Identifier: NCT00537095
Recruitment Status : Active, not recruiting
First Posted : September 28, 2007
Results First Posted : July 8, 2011
Last Update Posted : December 7, 2017
Sponsor:
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
  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

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) 
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 ]
  Show Outcome Measure 1

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

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

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


  Serious Adverse Events

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

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