ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
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
Enrollment 165

Recruitment Details 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 The main reason for non-randomisation was non-respect of eligibility criteria
Arm/Group Title ZD6474 PLACEBO
Hide Arm/Group Description ZD6474, Vandetanib 300mg PLACEBO
Period Title: Overall Study
Started 72 73
Completed 21 16
Not Completed 51 57
Reason Not Completed
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
Arm/Group Title ZD6474 PLACEBO Total
Hide Arm/Group Description ZD6474, Vandetanib 300mg PLACEBO Total of all reporting groups
Overall Number of Baseline Participants 72 73 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 72 participants 73 participants 145 participants
62.8  (11.21) 63.8  (11.59) 63  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 73 participants 145 participants
Female
33
  45.8%
34
  46.6%
67
  46.2%
Male
39
  54.2%
39
  53.4%
78
  53.8%
1.Primary Outcome
Title Time to Tumor Progression
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 PLACEBO
Hide Arm/Group Description:
ZD6474, Vandetanib 300mg
PLACEBO
Overall Number of Participants Analyzed 72 73
Median (95% Confidence Interval)
Unit of Measure: days
334
(232 to 421)
176
(119 to 267)
2.Secondary Outcome
Title Disease Control Rate at 6 Months
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 PLACEBO
Hide Arm/Group Description:
ZD6474, Vandetanib 300mg
PLACEBO
Overall Number of Participants Analyzed 72 73
Measure Type: Number
Unit of Measure: participants
41 31
3.Secondary Outcome
Title Objective Response Rate
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474 PLACEBO
Hide Arm/Group Description:
ZD6474, Vandetanib 300mg
PLACEBO
Overall Number of Participants Analyzed 72 73
Measure Type: Number
Unit of Measure: participants
6 4
4.Secondary Outcome
Title Time to Death
Hide Description Interim analysis time 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title ZD6474 PLACEBO
Hide Arm/Group Description:
ZD6474, Vandetanib 300mg
PLACEBO
Overall Number of Participants Analyzed 72 73
Measure Type: Number
Unit of Measure: participants
19 21
Time Frame [Not Specified]
Adverse Event Reporting 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
 
Arm/Group Title ZD6474 PLACEBO
Hide Arm/Group Description ZD6474, Vandetanib 300mg PLACEBO
All-Cause Mortality
ZD6474 PLACEBO
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ZD6474 PLACEBO
Affected / at Risk (%) Affected / at Risk (%)
Total   19/73 (26.03%)   12/72 (16.67%) 
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/73 (1.37%)  0/72 (0.00%) 
Cardiac disorders     
Angina pectoris * 1  1/73 (1.37%)  0/72 (0.00%) 
Arrythmia * 1  0/73 (0.00%)  1/72 (1.39%) 
Atrial fibrillation * 1  0/73 (0.00%)  1/72 (1.39%) 
Atrioventricular block * 1  1/73 (1.37%)  0/72 (0.00%) 
Bradyarrythmia  1  1/73 (1.37%)  0/72 (0.00%) 
Sinus bradycardia * 1  1/73 (1.37%)  0/72 (0.00%) 
Torsade de pointe * 1  1/73 (1.37%)  0/72 (0.00%) 
Ventricular tachycardia * 1  1/73 (1.37%)  0/72 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  1/73 (1.37%)  0/72 (0.00%) 
Inguinal hernia * 1  1/73 (1.37%)  0/72 (0.00%) 
Rectal haemorrhage * 1  1/73 (1.37%)  0/72 (0.00%) 
Vomiting * 1  1/73 (1.37%)  0/72 (0.00%) 
Infections and infestations     
Pneumonia * 1  2/73 (2.74%)  1/72 (1.39%) 
Appendicitis * 1  0/73 (0.00%)  1/72 (1.39%) 
Bronchopneumonia * 1  0/73 (0.00%)  1/72 (1.39%) 
Urinary Tract infection viral * 1  1/73 (1.37%)  0/72 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture * 1  1/73 (1.37%)  0/72 (0.00%) 
Tibia fracture * 1  0/73 (0.00%)  1/72 (1.39%) 
Investigations     
Electrocardiogramm QT prolonged * 1  1/73 (1.37%)  0/72 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/73 (0.00%)  1/72 (1.39%) 
Groin pain * 1  0/73 (0.00%)  1/72 (1.39%) 
Muscular weakness * 1  1/73 (1.37%)  0/72 (0.00%) 
Nervous system disorders     
Syncope * 1  1/73 (1.37%)  1/72 (1.39%) 
Cerebral hemorrage * 1  1/73 (1.37%)  0/72 (0.00%) 
Ischemic stroke * 1  0/73 (0.00%)  1/72 (1.39%) 
Loss of conciousness * 1  1/73 (1.37%)  0/72 (0.00%) 
Monoparesis * 1  0/73 (0.00%)  1/72 (1.39%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  2/73 (2.74%)  0/72 (0.00%) 
Haemoptysis * 1  0/73 (0.00%)  1/72 (1.39%) 
Interstitial lung disease * 1  0/73 (0.00%)  1/72 (1.39%) 
Lung disorder * 1  1/73 (1.37%)  0/72 (0.00%) 
Pleural effusion * 1  0/73 (0.00%)  1/72 (1.39%) 
Skin and subcutaneous tissue disorders     
Cutaneous lupus erythematosus * 1  1/73 (1.37%)  0/72 (0.00%) 
Photosensitivity reaction * 1  1/73 (1.37%)  0/72 (0.00%) 
Rash * 1  1/73 (1.37%)  0/72 (0.00%) 
Skin hemorrage * 1  1/73 (1.37%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZD6474 PLACEBO
Affected / at Risk (%) Affected / at Risk (%)
Total   72/73 (98.63%)   69/72 (95.83%) 
Blood and lymphatic system disorders     
Anaemia  1  0/73 (0.00%)  4/72 (5.56%) 
Leukopenia  1  4/73 (5.48%)  0/72 (0.00%) 
Neutropenia  1  4/73 (5.48%)  0/72 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  9/73 (12.33%)  7/72 (9.72%) 
Eye disorders     
Conjunctivitis  1  4/73 (5.48%)  1/72 (1.39%) 
Vision blurred  1  5/73 (6.85%)  0/72 (0.00%) 
Gastrointestinal disorders     
diarrhea  1  54/73 (73.97%)  12/72 (16.67%) 
Nausea  1  18/73 (24.66%)  11/72 (15.28%) 
abdominal pain  1  9/73 (12.33%)  5/72 (6.94%) 
Vomiting  1  7/73 (9.59%)  5/72 (6.94%) 
Constipation  1  5/73 (6.85%)  6/72 (8.33%) 
Dry mouth  1  5/73 (6.85%)  2/72 (2.78%) 
Dyspepsia  1  4/73 (5.48%)  2/72 (2.78%) 
Abdominal pain upper  1  1/73 (1.37%)  4/72 (5.56%) 
General disorders     
Asthenia  1  19/73 (26.03%)  16/72 (22.22%) 
Fatigue  1  17/73 (23.29%)  13/72 (18.06%) 
Chest pain  1  4/73 (5.48%)  4/72 (5.56%) 
Infections and infestations     
Folliculitis  1  7/73 (9.59%)  3/72 (4.17%) 
Bronchitis  1  4/73 (5.48%)  5/72 (6.94%) 
Nasopharyngitis  1  1/73 (1.37%)  4/72 (5.56%) 
Investigations     
Weight decrease  1  13/73 (17.81%)  5/72 (6.94%) 
Electrocardiogramm QT prolonged  1  17/73 (23.29%)  0/72 (0.00%) 
Metabolism and nutrition disorders     
Decrease appetite  1  19/73 (26.03%)  10/72 (13.89%) 
Hypokaliemia  1  9/73 (12.33%)  3/72 (4.17%) 
Hypocalcaemia  1  6/73 (8.22%)  5/72 (6.94%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  6/73 (8.22%)  5/72 (6.94%) 
Back pain  1  4/73 (5.48%)  6/72 (8.33%) 
Arthralgia  1  1/73 (1.37%)  4/72 (5.56%) 
myalgia  1  1/73 (1.37%)  4/72 (5.56%) 
Nervous system disorders     
Headache  1  12/73 (16.44%)  14/72 (19.44%) 
Psychiatric disorders     
Insomnia  1  8/73 (10.96%)  3/72 (4.17%) 
Depression  1  8/73 (10.96%)  0/72 (0.00%) 
Anxiety  1  5/73 (6.85%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  7/73 (9.59%)  9/72 (12.50%) 
Cough  1  4/73 (5.48%)  9/72 (12.50%) 
Dysphonia  1  4/73 (5.48%)  2/72 (2.78%) 
Epistaxis  1  5/73 (6.85%)  0/72 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  20/73 (27.40%)  6/72 (8.33%) 
Rash  1  18/73 (24.66%)  3/72 (4.17%) 
Dry skin  1  12/73 (16.44%)  4/72 (5.56%) 
Photosensitivity reaction  1  14/73 (19.18%)  2/72 (2.78%) 
Erythema  1  5/73 (6.85%)  4/72 (5.56%) 
Pruritus  1  4/73 (5.48%)  4/72 (5.56%) 
Pigmentation disorder  1  6/73 (8.22%)  1/72 (1.39%) 
Dermatitis acneiform  1  6/73 (8.22%)  0/72 (0.00%) 
Alopecia  1  4/73 (5.48%)  0/72 (0.00%) 
Eczema  1  4/73 (5.48%)  0/72 (0.00%) 
Skin lesion  1  4/73 (5.48%)  0/72 (0.00%) 
Vascular disorders     
Hypertension  1  25/73 (34.25%)  4/72 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
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 )
First Submitted: September 27, 2007
First Posted: September 28, 2007
Results First Submitted: April 27, 2011
Results First Posted: July 8, 2011
Last Update Posted: December 7, 2017