Try our beta test site

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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Thyroid Neoplasms
Interventions: Drug: Vandetanib
Other: Placebo

  Participant Flow
  Hide 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
  Hide 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) 
Gender 
[Units: Participants]
     
Female   33   34   67 
Male   39   39   78 


  Outcome Measures
  Show All 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
  Hide Other 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

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
ZD6474 ZD6474, Vandetanib 300mg
PLACEBO PLACEBO

Other Adverse Events
    ZD6474   PLACEBO
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   72/73 (98.63%)   69/72 (95.83%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   0/73 (0.00%)   4/72 (5.56%) 
Leukopenia † 1     
# participants affected / at risk   4/73 (5.48%)   0/72 (0.00%) 
Neutropenia † 1     
# participants affected / at risk   4/73 (5.48%)   0/72 (0.00%) 
Ear and labyrinth disorders     
Vertigo † 1     
# participants affected / at risk   9/73 (12.33%)   7/72 (9.72%) 
Eye disorders     
Conjunctivitis † 1     
# participants affected / at risk   4/73 (5.48%)   1/72 (1.39%) 
Vision blurred † 1     
# participants affected / at risk   5/73 (6.85%)   0/72 (0.00%) 
Gastrointestinal disorders     
diarrhea † 1     
# participants affected / at risk   54/73 (73.97%)   12/72 (16.67%) 
Nausea † 1     
# participants affected / at risk   18/73 (24.66%)   11/72 (15.28%) 
abdominal pain † 1     
# participants affected / at risk   9/73 (12.33%)   5/72 (6.94%) 
Vomiting † 1     
# participants affected / at risk   7/73 (9.59%)   5/72 (6.94%) 
Constipation † 1     
# participants affected / at risk   5/73 (6.85%)   6/72 (8.33%) 
Dry mouth † 1     
# participants affected / at risk   5/73 (6.85%)   2/72 (2.78%) 
Dyspepsia † 1     
# participants affected / at risk   4/73 (5.48%)   2/72 (2.78%) 
Abdominal pain upper † 1     
# participants affected / at risk   1/73 (1.37%)   4/72 (5.56%) 
General disorders     
Asthenia † 1     
# participants affected / at risk   19/73 (26.03%)   16/72 (22.22%) 
Fatigue † 1     
# participants affected / at risk   17/73 (23.29%)   13/72 (18.06%) 
Chest pain † 1     
# participants affected / at risk   4/73 (5.48%)   4/72 (5.56%) 
Infections and infestations     
Folliculitis † 1     
# participants affected / at risk   7/73 (9.59%)   3/72 (4.17%) 
Bronchitis † 1     
# participants affected / at risk   4/73 (5.48%)   5/72 (6.94%) 
Nasopharyngitis † 1     
# participants affected / at risk   1/73 (1.37%)   4/72 (5.56%) 
Investigations     
Weight decrease † 1     
# participants affected / at risk   13/73 (17.81%)   5/72 (6.94%) 
Electrocardiogramm QT prolonged † 1     
# participants affected / at risk   17/73 (23.29%)   0/72 (0.00%) 
Metabolism and nutrition disorders     
Decrease appetite † 1     
# participants affected / at risk   19/73 (26.03%)   10/72 (13.89%) 
Hypokaliemia † 1     
# participants affected / at risk   9/73 (12.33%)   3/72 (4.17%) 
Hypocalcaemia † 1     
# participants affected / at risk   6/73 (8.22%)   5/72 (6.94%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity † 1     
# participants affected / at risk   6/73 (8.22%)   5/72 (6.94%) 
Back pain † 1     
# participants affected / at risk   4/73 (5.48%)   6/72 (8.33%) 
Arthralgia † 1     
# participants affected / at risk   1/73 (1.37%)   4/72 (5.56%) 
myalgia † 1     
# participants affected / at risk   1/73 (1.37%)   4/72 (5.56%) 
Nervous system disorders     
Headache † 1     
# participants affected / at risk   12/73 (16.44%)   14/72 (19.44%) 
Psychiatric disorders     
Insomnia † 1     
# participants affected / at risk   8/73 (10.96%)   3/72 (4.17%) 
Depression † 1     
# participants affected / at risk   8/73 (10.96%)   0/72 (0.00%) 
Anxiety † 1     
# participants affected / at risk   5/73 (6.85%)   0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea † 1     
# participants affected / at risk   7/73 (9.59%)   9/72 (12.50%) 
Cough † 1     
# participants affected / at risk   4/73 (5.48%)   9/72 (12.50%) 
Dysphonia † 1     
# participants affected / at risk   4/73 (5.48%)   2/72 (2.78%) 
Epistaxis † 1     
# participants affected / at risk   5/73 (6.85%)   0/72 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne † 1     
# participants affected / at risk   20/73 (27.40%)   6/72 (8.33%) 
Rash † 1     
# participants affected / at risk   18/73 (24.66%)   3/72 (4.17%) 
Dry skin † 1     
# participants affected / at risk   12/73 (16.44%)   4/72 (5.56%) 
Photosensitivity reaction † 1     
# participants affected / at risk   14/73 (19.18%)   2/72 (2.78%) 
Erythema † 1     
# participants affected / at risk   5/73 (6.85%)   4/72 (5.56%) 
Pruritus † 1     
# participants affected / at risk   4/73 (5.48%)   4/72 (5.56%) 
Pigmentation disorder † 1     
# participants affected / at risk   6/73 (8.22%)   1/72 (1.39%) 
Dermatitis acneiform † 1     
# participants affected / at risk   6/73 (8.22%)   0/72 (0.00%) 
Alopecia † 1     
# participants affected / at risk   4/73 (5.48%)   0/72 (0.00%) 
Eczema † 1     
# participants affected / at risk   4/73 (5.48%)   0/72 (0.00%) 
Skin lesion † 1     
# participants affected / at risk   4/73 (5.48%)   0/72 (0.00%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   25/73 (34.25%)   4/72 (5.56%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.1



  Limitations and Caveats
  Hide 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