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ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer (ZODIAC)

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ClinicalTrials.gov Identifier: NCT00312377
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : May 24, 2011
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Non-small Cell Lung Cancer
Lung Cancer
Interventions Drug: Docetaxel
Drug: Vandetanib
Enrollment 1690
Recruitment Details First patient enrolled 08 May 2006, last patient enrolled 14 March 2008, cut off date 22 August 2008
Pre-assignment Details  
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
Period Title: Overall Study
Started 694 [1] 697 [1]
Completed 50 [2] 29 [2]
Not Completed 644 668
Reason Not Completed
Death             403             418
Withdrawal by Subject             23             30
Lost to Follow-up             9             12
Non-compliance             0             2
Randomised but never received treatment             6             6
Discontinue treatment survival follow up             202             200
Site ended participation in study             1             0
[1]
randomised patients
[2]
ongoing study treatment at data cut-off
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel Total
Hide Arm/Group Description Vandetanib 100 mg plus docetaxel Placebo plus docetaxel Total of all reporting groups
Overall Number of Baseline Participants 694 697 1391
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 694 participants 697 participants 1391 participants
58.5
(28 to 82)
58.4
(20 to 82)
58.45
(20 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 694 participants 697 participants 1391 participants
Female
497
  71.6%
473
  67.9%
970
  69.7%
Male
197
  28.4%
224
  32.1%
421
  30.3%
1.Primary Outcome
Title Progression-Free Survival (PFS) in the Overall Population
Hide Description Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
Time Frame RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
Vandetanib 100 mg plus docetaxel
Placebo plus docetaxel
Overall Number of Participants Analyzed 694 697
Median (95% Confidence Interval)
Unit of Measure: Weeks
17.3
(15 to 18)
14
(12.7 to 16.9)
2.Primary Outcome
Title Progression-Free Survival (PFS) in the Female Population
Hide Description Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
Time Frame RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
Vandetanib 100 mg plus docetaxel
Placebo plus docetaxel
Overall Number of Participants Analyzed 197 224
Median (95% Confidence Interval)
Unit of Measure: Weeks
20.1
(17.9 to 23.9)
18.3
(15 to 22.1)
3.Secondary Outcome
Title Overall Survival (OS) in the Overall Population
Hide Description Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Time Frame Time to death in months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
Vandetanib 100 mg plus docetaxel
Placebo plus docetaxel
Overall Number of Participants Analyzed 694 697
Median (95% Confidence Interval)
Unit of Measure: Months
10.6
(9.6 to 11.5)
10
(9.2 to 10.8)
4.Secondary Outcome
Title Overall Survival (OS) in the Female Population
Hide Description Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Time Frame Time to death in months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
Vandetanib 100 mg plus docetaxel
Placebo plus docetaxel
Overall Number of Participants Analyzed 197 224
Median (95% Confidence Interval)
Unit of Measure: Months
12.7
(10.5 to 17.1)
14.2
(10.8 to 16.2)
5.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.
Time Frame Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
Vandetanib 100 mg plus docetaxel
Placebo plus docetaxel
Overall Number of Participants Analyzed 694 697
Measure Type: Number
Unit of Measure: Participants
120 71
6.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.
Time Frame RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
Vandetanib 100 mg plus docetaxel
Placebo plus docetaxel
Overall Number of Participants Analyzed 694 697
Measure Type: Number
Unit of Measure: Participants
413 380
7.Secondary Outcome
Title Duration of Response (DoR)
Hide Description Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)
Time Frame RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
Vandetanib 100 mg plus docetaxel
Placebo plus docetaxel
Overall Number of Participants Analyzed 694 697
Median (Full Range)
Unit of Measure: Weeks
29.9
(7.14 to 72.29)
19.7
(9.71 to 41.86)
8.Secondary Outcome
Title Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).
Time Frame FACT-L questionnaires are to be administered every 3 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
Vandetanib 100 mg plus docetaxel
Placebo plus docetaxel
Overall Number of Participants Analyzed 694 697
Median (Inter-Quartile Range)
Unit of Measure: Weeks
15
(6.1 to 82.3)
11.9
(6.0 to 28.1)
9.Secondary Outcome
Title Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)
Hide Description

The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items.

Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.

A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of ‘worsened’ with no visit assessment of ‘improved’ within the next 21 days.

Time Frame FACT-L questionnaires are to be administered every 3 weeks after randomisation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description:
Vandetanib 100 mg plus docetaxel
Placebo plus docetaxel
Overall Number of Participants Analyzed 694 697
Median (Inter-Quartile Range)
Unit of Measure: Weeks
12.3
(5.9 to 36.7)
11.9
(6 to 28.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Hide Arm/Group Description Vandetanib 100 mg plus docetaxel Placebo plus docetaxel
All-Cause Mortality
Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   263/694 (37.90%)   232/697 (33.29%) 
Blood and lymphatic system disorders     
Febrile Neutropenia  1  46/694 (6.63%)  38/697 (5.45%) 
Neutropenia  1  16/694 (2.31%)  18/697 (2.58%) 
Anaemia  1  4/694 (0.58%)  6/697 (0.86%) 
Leukopenia  1  3/694 (0.43%)  2/697 (0.29%) 
Leukocytosis  1  0/694 (0.00%)  2/697 (0.29%) 
Bone Marrow Failure  1  1/694 (0.14%)  0/697 (0.00%) 
Febrile Bone Marrow Aplasia  1  1/694 (0.14%)  0/697 (0.00%) 
Iron Deficiency Anaemia  1  1/694 (0.14%)  0/697 (0.00%) 
Thrombocytopenia  1  1/694 (0.14%)  1/697 (0.14%) 
Cardiac disorders     
Atrial Fibrillation  1  3/694 (0.43%)  10/697 (1.43%) 
Myocardial Infarction  1  0/694 (0.00%)  4/697 (0.57%) 
Cardiac Arrest  1  1/694 (0.14%)  3/697 (0.43%) 
Cardiac Failure  1  0/694 (0.00%)  3/697 (0.43%) 
Acute Myocardial Infarction  1  2/694 (0.29%)  2/697 (0.29%) 
Atrial Flutter  1  2/694 (0.29%)  1/697 (0.14%) 
Angina Unstable  1  1/694 (0.14%)  0/697 (0.00%) 
Arrhythmia  1  0/694 (0.00%)  1/697 (0.14%) 
Atrioventricular Block Complete  1  1/694 (0.14%)  0/697 (0.00%) 
Atrioventricular Block Second Degree  1  0/694 (0.00%)  1/697 (0.14%) 
Cardiac Tamponade  1  0/694 (0.00%)  1/697 (0.14%) 
Cardio-Respiratory Arrest  1  1/694 (0.14%)  0/697 (0.00%) 
Extrasystoles  1  1/694 (0.14%)  0/697 (0.00%) 
Pericardial Effusion  1  1/694 (0.14%)  0/697 (0.00%) 
Pericarditis  1  0/694 (0.00%)  1/697 (0.14%) 
Supraventricular Tachycardia  1  1/694 (0.14%)  0/697 (0.00%) 
Tachyarrhythmia  1  0/694 (0.00%)  1/697 (0.14%) 
Tachycardia  1  1/694 (0.14%)  0/697 (0.00%) 
Ventricular Extrasystoles  1  0/694 (0.00%)  1/697 (0.14%) 
Congenital, familial and genetic disorders     
Hereditary Angioedema  1  1/694 (0.14%)  0/697 (0.00%) 
Ear and labyrinth disorders     
Deafness Unilateral  1  1/694 (0.14%)  0/697 (0.00%) 
Vertigo  1  1/694 (0.14%)  0/697 (0.00%) 
Eye disorders     
Ocular Surface Disease  1  1/694 (0.14%)  0/697 (0.00%) 
Retinal Artery Occlusion  1  1/694 (0.14%)  0/697 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  14/694 (2.02%)  11/697 (1.58%) 
Vomiting  1  7/694 (1.01%)  8/697 (1.15%) 
Nausea  1  5/694 (0.72%)  4/697 (0.57%) 
Abdominal Pain Upper  1  4/694 (0.58%)  1/697 (0.14%) 
Constipation  1  0/694 (0.00%)  3/697 (0.43%) 
Gastric Ulcer  1  0/694 (0.00%)  3/697 (0.43%) 
Abdominal Pain  1  2/694 (0.29%)  1/697 (0.14%) 
Gastrointestinal Haemorrhage  1  1/694 (0.14%)  2/697 (0.29%) 
Stomatitis  1  2/694 (0.29%)  0/697 (0.00%) 
Appendicitis Perforated  1  1/694 (0.14%)  0/697 (0.00%) 
Ascites  1  0/694 (0.00%)  1/697 (0.14%) 
Dyspepsia  1  0/694 (0.00%)  1/697 (0.14%) 
Dysphagia  1  1/694 (0.14%)  1/697 (0.14%) 
Enteritis  1  1/694 (0.14%)  0/697 (0.00%) 
Enterocolitis  1  1/694 (0.14%)  0/697 (0.00%) 
Gastric Haemorrhage  1  0/694 (0.00%)  1/697 (0.14%) 
Gastritis  1  0/694 (0.00%)  1/697 (0.14%) 
Gastrointestinal Inflammation  1  1/694 (0.14%)  0/697 (0.00%) 
Haematochezia  1  1/694 (0.14%)  0/697 (0.00%) 
Ileus Paralytic  1  1/694 (0.14%)  0/697 (0.00%) 
Inguinal Hernia  1  1/694 (0.14%)  0/697 (0.00%) 
Intestinal Obstruction  1  1/694 (0.14%)  0/697 (0.00%) 
Lower Gastrointestinal Haemorrhage  1  1/694 (0.14%)  0/697 (0.00%) 
Oesophageal Fistula  1  1/694 (0.14%)  0/697 (0.00%) 
Oesophageal Stenosis  1  1/694 (0.14%)  0/697 (0.00%) 
Proctitis Haemorrhagic  1  0/694 (0.00%)  1/697 (0.14%) 
Upper Gastrointestinal Haemorrhage  1  0/694 (0.00%)  1/697 (0.14%) 
General disorders     
Pyrexia  1  13/694 (1.87%)  12/697 (1.72%) 
Asthenia  1  2/694 (0.29%)  5/697 (0.72%) 
Chest Pain  1  3/694 (0.43%)  0/697 (0.00%) 
Malaise  1  3/694 (0.43%)  0/697 (0.00%) 
Performance Status Decreased  1  3/694 (0.43%)  0/697 (0.00%) 
Fatigue  1  1/694 (0.14%)  2/697 (0.29%) 
General Physical Health Deterioration  1  1/694 (0.14%)  2/697 (0.29%) 
Mucosal Inflammation  1  1/694 (0.14%)  2/697 (0.29%) 
Chills  1  1/694 (0.14%)  0/697 (0.00%) 
Death  1  0/694 (0.00%)  1/697 (0.14%) 
Multi-Organ Failure  1  1/694 (0.14%)  1/697 (0.14%) 
Pain  1  1/694 (0.14%)  0/697 (0.00%) 
Sudden Death  1  1/694 (0.14%)  1/697 (0.14%) 
Systemic Inflammatory Response Syndrome  1  0/694 (0.00%)  1/697 (0.14%) 
Immune system disorders     
Anaphylactic Shock  1  1/694 (0.14%)  2/697 (0.29%) 
Drug Hypersensitivity  1  2/694 (0.29%)  1/697 (0.14%) 
Infections and infestations     
Pneumonia  1  33/694 (4.76%)  26/697 (3.73%) 
Respiratory Tract Infection  1  5/694 (0.72%)  6/697 (0.86%) 
Sepsis  1  5/694 (0.72%)  5/697 (0.72%) 
Upper Respiratory Tract Infection  1  0/694 (0.00%)  5/697 (0.72%) 
Gastroenteritis  1  4/694 (0.58%)  3/697 (0.43%) 
Lung Infection  1  4/694 (0.58%)  2/697 (0.29%) 
Urinary Tract Infection  1  4/694 (0.58%)  3/697 (0.43%) 
Lower Respiratory Tract Infection  1  3/694 (0.43%)  1/697 (0.14%) 
Septic Shock  1  3/694 (0.43%)  1/697 (0.14%) 
Bacterial Infection  1  2/694 (0.29%)  0/697 (0.00%) 
Bronchitis  1  0/694 (0.00%)  2/697 (0.29%) 
Bronchopneumonia  1  0/694 (0.00%)  2/697 (0.29%) 
Infection  1  0/694 (0.00%)  2/697 (0.29%) 
Neutropenic Infection  1  1/694 (0.14%)  2/697 (0.29%) 
Urosepsis  1  2/694 (0.29%)  0/697 (0.00%) 
Appendicitis  1  1/694 (0.14%)  0/697 (0.00%) 
Bacteraemia  1  1/694 (0.14%)  0/697 (0.00%) 
Bacterial Sepsis  1  1/694 (0.14%)  0/697 (0.00%) 
Bronchopulmonary Aspergillosis  1  1/694 (0.14%)  0/697 (0.00%) 
Catheter Related Infection  1  0/694 (0.00%)  1/697 (0.14%) 
Cellulitis  1  1/694 (0.14%)  0/697 (0.00%) 
Central Line Infection  1  0/694 (0.00%)  1/697 (0.14%) 
Diverticulitis  1  1/694 (0.14%)  1/697 (0.14%) 
Empyema  1  1/694 (0.14%)  0/697 (0.00%) 
Epiglottitis  1  0/694 (0.00%)  1/697 (0.14%) 
Gastrointestinal Infection  1  1/694 (0.14%)  0/697 (0.00%) 
Infective Exacerbation Of Chronic Obstructive Airways Disease  1  0/694 (0.00%)  1/697 (0.14%) 
Infective Myositis  1  1/694 (0.14%)  0/697 (0.00%) 
Lobar Pneumonia  1  1/694 (0.14%)  0/697 (0.00%) 
Lung Abscess  1  1/694 (0.14%)  1/697 (0.14%) 
Oesophageal Candidiasis  1  1/694 (0.14%)  0/697 (0.00%) 
Perianal Abscess  1  0/694 (0.00%)  1/697 (0.14%) 
Pneumocystis Jiroveci Pneumonia  1  1/694 (0.14%)  0/697 (0.00%) 
Pneumonia Streptococcal  1  0/694 (0.00%)  1/697 (0.14%) 
Pyothorax  1  1/694 (0.14%)  0/697 (0.00%) 
Rash Pustular  1  1/694 (0.14%)  0/697 (0.00%) 
Rectal Abscess  1  1/694 (0.14%)  0/697 (0.00%) 
Respiratory Tract Infection Bacterial  1  0/694 (0.00%)  1/697 (0.14%) 
Skin Bacterial Infection  1  1/694 (0.14%)  0/697 (0.00%) 
Staphylococcal Infection  1  1/694 (0.14%)  0/697 (0.00%) 
Tuberculosis  1  1/694 (0.14%)  0/697 (0.00%) 
Injury, poisoning and procedural complications     
Femur Fracture  1  2/694 (0.29%)  1/697 (0.14%) 
Humerus Fracture  1  0/694 (0.00%)  2/697 (0.29%) 
Brain Contusion  1  0/694 (0.00%)  1/697 (0.14%) 
Facial Bones Fracture  1  0/694 (0.00%)  1/697 (0.14%) 
Foot Fracture  1  1/694 (0.14%)  0/697 (0.00%) 
Hip Fracture  1  1/694 (0.14%)  0/697 (0.00%) 
Lower Limb Fracture  1  1/694 (0.14%)  0/697 (0.00%) 
Multiple Fractures  1  0/694 (0.00%)  1/697 (0.14%) 
Radiation Pneumonitis  1  1/694 (0.14%)  0/697 (0.00%) 
Skin Laceration  1  0/694 (0.00%)  1/697 (0.14%) 
Skull Fracture  1  0/694 (0.00%)  1/697 (0.14%) 
Weight Decreased  1  0/694 (0.00%)  2/697 (0.29%) 
White Blood Cell Count Decreased  1  0/694 (0.00%)  2/697 (0.29%) 
Alanine Aminotransferase Increased  1  0/694 (0.00%)  1/697 (0.14%) 
Aspartate Aminotransferase Increased  1  0/694 (0.00%)  1/697 (0.14%) 
Blood Alkaline Phosphatase Increased  1  0/694 (0.00%)  1/697 (0.14%) 
Blood Pressure Orthostatic Decreased  1  1/694 (0.14%)  0/697 (0.00%) 
Electrocardiogram T Wave Abnormal  1  1/694 (0.14%)  0/697 (0.00%) 
Neutrophil Count Decreased  1  0/694 (0.00%)  1/697 (0.14%) 
Metabolism and nutrition disorders     
Anorexia  1  3/694 (0.43%)  2/697 (0.29%) 
Dehydration  1  1/694 (0.14%)  3/697 (0.43%) 
Hyperkalaemia  1  1/694 (0.14%)  2/697 (0.29%) 
Hypoglycaemia  1  2/694 (0.29%)  2/697 (0.29%) 
Hyponatraemia  1  1/694 (0.14%)  2/697 (0.29%) 
Diabetes Mellitus  1  1/694 (0.14%)  0/697 (0.00%) 
Failure To Thrive  1  1/694 (0.14%)  0/697 (0.00%) 
Hypercalcaemia  1  1/694 (0.14%)  1/697 (0.14%) 
Hyperglycaemia  1  1/694 (0.14%)  1/697 (0.14%) 
Hypokalaemia  1  1/694 (0.14%)  0/697 (0.00%) 
Type 2 Diabetes Mellitus  1  0/694 (0.00%)  1/697 (0.14%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  2/694 (0.29%)  4/697 (0.57%) 
Musculoskeletal Chest Pain  1  3/694 (0.43%)  4/697 (0.57%) 
Arthralgia  1  0/694 (0.00%)  1/697 (0.14%) 
Bone Pain  1  1/694 (0.14%)  1/697 (0.14%) 
Flank Pain  1  0/694 (0.00%)  1/697 (0.14%) 
Muscular Weakness  1  1/694 (0.14%)  1/697 (0.14%) 
Musculoskeletal Pain  1  0/694 (0.00%)  1/697 (0.14%) 
Myalgia  1  0/694 (0.00%)  1/697 (0.14%) 
Pain In Extremity  1  1/694 (0.14%)  1/697 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour Pain  1  2/694 (0.29%)  2/697 (0.29%) 
Metastatic Pain  1  1/694 (0.14%)  0/697 (0.00%) 
Myelodysplastic Syndrome  1  1/694 (0.14%)  0/697 (0.00%) 
Nervous system disorders     
Convulsion  1  4/694 (0.58%)  1/697 (0.14%) 
Dizziness  1  3/694 (0.43%)  4/697 (0.57%) 
Headache  1  1/694 (0.14%)  3/697 (0.43%) 
Loss Of Consciousness  1  3/694 (0.43%)  1/697 (0.14%) 
Somnolence  1  0/694 (0.00%)  2/697 (0.29%) 
Syncope  1  2/694 (0.29%)  2/697 (0.29%) 
Altered State Of Consciousness  1  1/694 (0.14%)  0/697 (0.00%) 
Ataxia  1  0/694 (0.00%)  1/697 (0.14%) 
Brachial Plexopathy  1  0/694 (0.00%)  1/697 (0.14%) 
Cauda Equina Syndrome  1  0/694 (0.00%)  1/697 (0.14%) 
Cerebral Haemorrhage  1  0/694 (0.00%)  1/697 (0.14%) 
Cerebral Infarction  1  1/694 (0.14%)  0/697 (0.00%) 
Cerebral Ischaemia  1  1/694 (0.14%)  1/697 (0.14%) 
Cerebrovascular Accident  1  1/694 (0.14%)  1/697 (0.14%) 
Coma  1  0/694 (0.00%)  1/697 (0.14%) 
Coma Hepatic  1  0/694 (0.00%)  1/697 (0.14%) 
Dyskinesia  1  0/694 (0.00%)  1/697 (0.14%) 
Hemiparesis  1  1/694 (0.14%)  0/697 (0.00%) 
Ischaemic Stroke  1  1/694 (0.14%)  0/697 (0.00%) 
Paraplegia  1  0/694 (0.00%)  1/697 (0.14%) 
Peripheral Sensory Neuropathy  1  1/694 (0.14%)  0/697 (0.00%) 
Polyneuropathy  1  1/694 (0.14%)  0/697 (0.00%) 
Pyramidal Tract Syndrome  1  0/694 (0.00%)  1/697 (0.14%) 
Spinal Cord Compression  1  1/694 (0.14%)  0/697 (0.00%) 
Subarachnoid Haemorrhage  1  0/694 (0.00%)  1/697 (0.14%) 
Psychiatric disorders     
Mental Status Changes  1  2/694 (0.29%)  1/697 (0.14%) 
Anxiety  1  0/694 (0.00%)  1/697 (0.14%) 
Confusional State  1  1/694 (0.14%)  0/697 (0.00%) 
Delirium  1  0/694 (0.00%)  1/697 (0.14%) 
Psychotic Behaviour  1  1/694 (0.14%)  0/697 (0.00%) 
Suicidal Ideation  1  0/694 (0.00%)  1/697 (0.14%) 
Renal and urinary disorders     
Dysuria  1  0/694 (0.00%)  2/697 (0.29%) 
Renal Failure  1  2/694 (0.29%)  1/697 (0.14%) 
Haematuria  1  1/694 (0.14%)  0/697 (0.00%) 
Nephrolithiasis  1  0/694 (0.00%)  1/697 (0.14%) 
Renal Failure Acute  1  1/694 (0.14%)  0/697 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  22/694 (3.17%)  21/697 (3.01%) 
Interstitial Lung Disease  1  12/694 (1.73%)  6/697 (0.86%) 
Pulmonary Embolism  1  2/694 (0.29%)  8/697 (1.15%) 
Haemoptysis  1  5/694 (0.72%)  6/697 (0.86%) 
Respiratory Failure  1  5/694 (0.72%)  6/697 (0.86%) 
Pneumonitis  1  4/694 (0.58%)  5/697 (0.72%) 
Pneumothorax  1  1/694 (0.14%)  5/697 (0.72%) 
Pleural Effusion  1  4/694 (0.58%)  3/697 (0.43%) 
Chronic Obstructive Pulmonary Disease  1  0/694 (0.00%)  3/697 (0.43%) 
Cough  1  3/694 (0.43%)  0/697 (0.00%) 
Aspiration  1  2/694 (0.29%)  0/697 (0.00%) 
Epistaxis  1  0/694 (0.00%)  2/697 (0.29%) 
Hypoxia  1  2/694 (0.29%)  1/697 (0.14%) 
Pulmonary Haemorrhage  1  1/694 (0.14%)  2/697 (0.29%) 
Respiratory Distress  1  1/694 (0.14%)  2/697 (0.29%) 
Acute Respiratory Distress Syndrome  1  1/694 (0.14%)  0/697 (0.00%) 
Asthma  1  0/694 (0.00%)  1/697 (0.14%) 
Bronchospasm  1  1/694 (0.14%)  0/697 (0.00%) 
Cryptogenic Organising Pneumonia  1  1/694 (0.14%)  0/697 (0.00%) 
Diaphragmatic Rupture  1  0/694 (0.00%)  1/697 (0.14%) 
Dyspnoea Exertional  1  0/694 (0.00%)  1/697 (0.14%) 
Hydropneumothorax  1  1/694 (0.14%)  0/697 (0.00%) 
Laryngeal Inflammation  1  1/694 (0.14%)  0/697 (0.00%) 
Lung Infiltration  1  0/694 (0.00%)  1/697 (0.14%) 
Pleurisy  1  0/694 (0.00%)  1/697 (0.14%) 
Pneumonia Aspiration  1  1/694 (0.14%)  0/697 (0.00%) 
Productive Cough  1  0/694 (0.00%)  1/697 (0.14%) 
Pulmonary Alveolar Haemorrhage  1  0/694 (0.00%)  1/697 (0.14%) 
Pulmonary Oedema  1  0/694 (0.00%)  1/697 (0.14%) 
Respiratory Depression  1  1/694 (0.14%)  0/697 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  15/694 (2.16%)  1/697 (0.14%) 
Photosensitivity Reaction  1  5/694 (0.72%)  0/697 (0.00%) 
Toxic Epidermal Necrolysis  1  4/694 (0.58%)  0/697 (0.00%) 
Dermatitis Exfoliative  1  3/694 (0.43%)  0/697 (0.00%) 
Stevens-Johnson Syndrome  1  3/694 (0.43%)  0/697 (0.00%) 
Drug Eruption  1  2/694 (0.29%)  0/697 (0.00%) 
Erythema  1  2/694 (0.29%)  0/697 (0.00%) 
Pruritus  1  2/694 (0.29%)  0/697 (0.00%) 
Rash Erythematous  1  2/694 (0.29%)  0/697 (0.00%) 
Toxic Skin Eruption  1  2/694 (0.29%)  0/697 (0.00%) 
Dermatitis  1  1/694 (0.14%)  0/697 (0.00%) 
Erythema Multiforme  1  1/694 (0.14%)  0/697 (0.00%) 
Exfoliative Rash  1  1/694 (0.14%)  0/697 (0.00%) 
Palmar-Plantar Erythrodysaesthesia Syndrome  1  1/694 (0.14%)  0/697 (0.00%) 
Rash Maculo-Papular  1  1/694 (0.14%)  0/697 (0.00%) 
Skin Toxicity  1  1/694 (0.14%)  0/697 (0.00%) 
Telangiectasia  1  1/694 (0.14%)  0/697 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis  1  1/694 (0.14%)  6/697 (0.86%) 
Hypotension  1  5/694 (0.72%)  1/697 (0.14%) 
Peripheral Arterial Occlusive Disease  1  1/694 (0.14%)  0/697 (0.00%) 
Peripheral Ischaemia  1  1/694 (0.14%)  0/697 (0.00%) 
Shock  1  0/694 (0.00%)  1/697 (0.14%) 
Subclavian Vein Thrombosis  1  1/694 (0.14%)  0/697 (0.00%) 
Superior Vena Caval Stenosis  1  1/694 (0.14%)  0/697 (0.00%) 
Vasculitis  1  0/694 (0.00%)  1/697 (0.14%) 
Vena Cava Thrombosis  1  0/694 (0.00%)  1/697 (0.14%) 
Venous Thrombosis  1  1/694 (0.14%)  0/697 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib 100 mg Plus Docetaxel Placebo Plus Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   637/694 (91.79%)   630/697 (90.39%) 
Blood and lymphatic system disorders     
Neutropenia  1  212/694 (30.55%)  174/697 (24.96%) 
Leukopenia  1  125/694 (18.01%)  106/697 (15.21%) 
Anaemia  1  68/694 (9.80%)  98/697 (14.06%) 
Gastrointestinal disorders     
Diarrhoea  1  284/694 (40.92%)  218/697 (31.28%) 
Nausea  1  158/694 (22.77%)  221/697 (31.71%) 
Vomiting  1  105/694 (15.13%)  141/697 (20.23%) 
Constipation  1  119/694 (17.15%)  140/697 (20.09%) 
Stomatitis  1  80/694 (11.53%)  80/697 (11.48%) 
Abdominal Pain  1  41/694 (5.91%)  50/697 (7.17%) 
Dyspepsia  1  37/694 (5.33%)  25/697 (3.59%) 
Abdominal Pain Upper  1  30/694 (4.32%)  36/697 (5.16%) 
General disorders     
Fatigue  1  208/694 (29.97%)  214/697 (30.70%) 
Pyrexia  1  127/694 (18.30%)  110/697 (15.78%) 
Asthenia  1  105/694 (15.13%)  90/697 (12.91%) 
Oedema Peripheral  1  49/694 (7.06%)  57/697 (8.18%) 
Mucosal Inflammation  1  49/694 (7.06%)  38/697 (5.45%) 
Infections and infestations     
Nasopharyngitis  1  41/694 (5.91%)  37/697 (5.31%) 
Weight Decreased  1  54/694 (7.78%)  41/697 (5.88%) 
Metabolism and nutrition disorders     
Anorexia  1  199/694 (28.67%)  204/697 (29.27%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  90/694 (12.97%)  78/697 (11.19%) 
Back Pain  1  51/694 (7.35%)  62/697 (8.90%) 
Arthralgia  1  61/694 (8.79%)  52/697 (7.46%) 
Pain In Extremity  1  39/694 (5.62%)  31/697 (4.45%) 
Musculoskeletal Pain  1  35/694 (5.04%)  30/697 (4.30%) 
Nervous system disorders     
Headache  1  58/694 (8.36%)  62/697 (8.90%) 
Dizziness  1  43/694 (6.20%)  58/697 (8.32%) 
Dysgeusia  1  40/694 (5.76%)  49/697 (7.03%) 
Peripheral Sensory Neuropathy  1  42/694 (6.05%)  48/697 (6.89%) 
Paraesthesia  1  42/694 (6.05%)  42/697 (6.03%) 
Psychiatric disorders     
Insomnia  1  95/694 (13.69%)  73/697 (10.47%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  130/694 (18.73%)  133/697 (19.08%) 
Dyspnoea  1  102/694 (14.70%)  122/697 (17.50%) 
Epistaxis  1  50/694 (7.20%)  27/697 (3.87%) 
Haemoptysis  1  37/694 (5.33%)  45/697 (6.46%) 
Dysphonia  1  41/694 (5.91%)  20/697 (2.87%) 
Hiccups  1  30/694 (4.32%)  41/697 (5.88%) 
Skin and subcutaneous tissue disorders     
Rash  1  282/694 (40.63%)  166/697 (23.82%) 
Alopecia  1  230/694 (33.14%)  240/697 (34.43%) 
Pruritus  1  65/694 (9.37%)  42/697 (6.03%) 
Nail Disorder  1  52/694 (7.49%)  46/697 (6.60%) 
Dry Skin  1  45/694 (6.48%)  30/697 (4.30%) 
Photosensitivity Reaction  1  42/694 (6.05%)  1/697 (0.14%) 
Vascular disorders     
Hypertension  1  41/694 (5.91%)  13/697 (1.87%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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: NCT00312377     History of Changes
Other Study ID Numbers: D4200C00032
6474IL/0032
2005-004749-32 ( EudraCT Number )
First Submitted: April 6, 2006
First Posted: April 10, 2006
Results First Submitted: April 27, 2011
Results First Posted: May 24, 2011
Last Update Posted: September 30, 2016