Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy

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: NCT00364351
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : May 24, 2011
Last Update Posted : January 25, 2018
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
Condition Non Small Cell Lung Cancer
Interventions Drug: Vandetanib
Drug: Erlotinib
Enrollment 1574
Recruitment Details First patient enrolled 24 August 2006, last patient enrolled 31 October 2007, cut off date 26 September 2008. 1574 patients were enrolled in the study.
Pre-assignment Details 1574 patients were enrolled/screened to the study but only 1240 patients were entered treatment/randomized.
Arm/Group Title Vandetanib Erlotinib
Hide Arm/Group Description Vandetanib 300 mg tablet taken once daily plus a placebo for erlotinib Erlotinib 150 mg tablet taken once daily plus a placebo for vandetanib
Period Title: Overall Study
Started 623 [1] 617 [1]
Completed 31 [2] 34 [2]
Not Completed 592 583
Reason Not Completed
Adverse Event             90             44
Condition under investigation worsened             469             497
Prohibited concomitant medication             0             2
Lost to Follow-up             1             1
Withdrawal by Subject             30             29
Incorrect enrollment             1             1
Sponsor decision             1             0
Poor treatment compliance             0             3
Investigator error             0             2
Patient could not travel to site             0             1
Randomised treatment not started             0             3
[1]
randomised patients
[2]
Ongoing study treatment at data cut-off date 26 Sep 2008.
Arm/Group Title Vandetanib Erlotinib Total
Hide Arm/Group Description Vandetanib 300 mg Erlotinib Total of all reporting groups
Overall Number of Baseline Participants 623 617 1240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 623 participants 617 participants 1240 participants
60
(26 to 92)
61
(26 to 85)
60
(26 to 92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 623 participants 617 participants 1240 participants
Female
242
  38.8%
224
  36.3%
466
  37.6%
Male
381
  61.2%
393
  63.7%
774
  62.4%
1.Primary Outcome
Title Progression-Free Survival (PFS)
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 Response Evaluation Criteria In Solid Tumors (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 progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Erlotinib
Hide Arm/Group Description:
Vandetanib 300 mg
Erlotinib
Overall Number of Participants Analyzed 623 617
Median (Full Range)
Unit of Measure: Weeks
11.3
(0.14 to 75.43)
8.9
(0.43 to 80.43)
2.Secondary Outcome
Title Overall Survival (OS)
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 Erlotinib
Hide Arm/Group Description:
Vandetanib 300 mg
Erlotinib
Overall Number of Participants Analyzed 623 617
Median (Full Range)
Unit of Measure: Months
6.9
(0.03 to 18.46)
7.8
(0.10 to 20.04)
3.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 RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Erlotinib
Hide Arm/Group Description:
Vandetanib 300 mg
Erlotinib
Overall Number of Participants Analyzed 623 617
Measure Type: Number
Unit of Measure: Participants
75 74
4.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 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 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 >= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation.
Time Frame RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Erlotinib
Hide Arm/Group Description:
Vandetanib 300 mg
Erlotinib
Overall Number of Participants Analyzed 623 617
Measure Type: Number
Unit of Measure: Participants
254 242
5.Secondary Outcome
Title Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain
Hide Description

Pain was assessed as the average score of two items: Question 9 ("Have you had pain") and 19 ("Did pain interfere with your daily activities") of the QLQ-C30.

Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is 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 28 days.

Time Frame Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Erlotinib
Hide Arm/Group Description:
Vandetanib 300 mg
Erlotinib
Overall Number of Participants Analyzed 623 617
Median (Inter-Quartile Range)
Unit of Measure: Weeks
11.1
(4.4 to 26)
9.9
(4.3 to 24.3)
6.Secondary Outcome
Title Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea
Hide Description

Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 ("Were you short of breath") and Question 3 of the QLQ-C30 ("Were you short of breath when you rested"), Questions 4 ("Were you short of breath when you walked") and 5 ("Were you short of breath when you climbed stairs") of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires).

Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is 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 28 days.

Time Frame Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Erlotinib
Hide Arm/Group Description:
Vandetanib 300 mg
Erlotinib
Overall Number of Participants Analyzed 623 617
Median (Inter-Quartile Range)
Unit of Measure: Weeks
12
(5.7 to 29.7)
12.4
(5.1 to 34.4)
7.Secondary Outcome
Title Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough
Hide Description

Cough was assessed using Question 1 ("How much did you cough") of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires).

Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is 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 28 days.

Time Frame Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Erlotinib
Hide Arm/Group Description:
Vandetanib 300 mg
Erlotinib
Overall Number of Participants Analyzed 623 617
Median (Inter-Quartile Range)
Unit of Measure: Weeks
15.6
(8.1 to 36.1)
14.1
(7 to 37.6)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Analysis Set included all randomized participant who received at least 1 dose of randomized treatment, 623 in vandetanib and 614 in erlotinib.
 
Arm/Group Title Vandetanib Erlotinib
Hide Arm/Group Description Vandetanib 300 mg. Erlotinib.
All-Cause Mortality
Vandetanib Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   197/623 (31.62%)   155/614 (25.24%) 
Blood and lymphatic system disorders     
Anaemia  1  1/623 (0.16%)  5/614 (0.81%) 
Febrile Neutropenia  1  4/623 (0.64%)  1/614 (0.16%) 
Leukocytosis  1  0/623 (0.00%)  2/614 (0.33%) 
Leukopenia  1  1/623 (0.16%)  0/614 (0.00%) 
Pancytopenia  1  0/623 (0.00%)  1/614 (0.16%) 
Thrombocytopenia  1  1/623 (0.16%)  0/614 (0.00%) 
Thrombotic Thrombocytopenic Purpura  1  1/623 (0.16%)  0/614 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction  1  2/623 (0.32%)  0/614 (0.00%) 
Atrial Fibrillation  1  2/623 (0.32%)  1/614 (0.16%) 
Atrial Flutter  1  1/623 (0.16%)  1/614 (0.16%) 
Bradycardia  1  1/623 (0.16%)  0/614 (0.00%) 
Cardiac Arrest  1  1/623 (0.16%)  0/614 (0.00%) 
Cardiac Failure  1  2/623 (0.32%)  0/614 (0.00%) 
Cardio-Respiratory Arrest  1  3/623 (0.48%)  0/614 (0.00%) 
Cardiopulmonary Failure  1  1/623 (0.16%)  0/614 (0.00%) 
Myocardial Infarction  1  6/623 (0.96%)  2/614 (0.33%) 
Pericardial Effusion  1  1/623 (0.16%)  0/614 (0.00%) 
Postinfarction Angina  1  1/623 (0.16%)  0/614 (0.00%) 
Right Ventricular Failure  1  1/623 (0.16%)  0/614 (0.00%) 
Sinus Tachycardia  1  0/623 (0.00%)  1/614 (0.16%) 
Supraventricular Tachycardia  1  0/623 (0.00%)  1/614 (0.16%) 
Tachycardia  1  0/623 (0.00%)  1/614 (0.16%) 
Torsade De Pointes  1  1/623 (0.16%)  0/614 (0.00%) 
Ventricular Fibrillation  1  2/623 (0.32%)  0/614 (0.00%) 
Ventricular Tachycardia  1  1/623 (0.16%)  0/614 (0.00%) 
Eye disorders     
Ulcerative Keratitis  1  1/623 (0.16%)  0/614 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  4/623 (0.64%)  2/614 (0.33%) 
Abdominal Wall Haematoma  1  0/623 (0.00%)  1/614 (0.16%) 
Colitis Ischaemic  1  0/623 (0.00%)  1/614 (0.16%) 
Constipation  1  0/623 (0.00%)  1/614 (0.16%) 
Diarrhoea  1  19/623 (3.05%)  8/614 (1.30%) 
Dysphagia  1  4/623 (0.64%)  4/614 (0.65%) 
Enteritis  1  1/623 (0.16%)  0/614 (0.00%) 
Gastritis  1  1/623 (0.16%)  0/614 (0.00%) 
Gastrointestinal Haemorrhage  1  1/623 (0.16%)  0/614 (0.00%) 
Gastrointestinal Ulcer Haemorrhage  1  0/623 (0.00%)  1/614 (0.16%) 
Haemorrhoids  1  1/623 (0.16%)  0/614 (0.00%) 
Inguinal Hernia Strangulated  1  0/623 (0.00%)  1/614 (0.16%) 
Nausea  1  5/623 (0.80%)  5/614 (0.81%) 
Oesophageal Stenosis  1  0/623 (0.00%)  1/614 (0.16%) 
Pancreatitis  1  0/623 (0.00%)  1/614 (0.16%) 
Small Intestinal Obstruction  1  1/623 (0.16%)  0/614 (0.00%) 
Vomiting  1  9/623 (1.44%)  9/614 (1.47%) 
General disorders     
Asthenia  1  4/623 (0.64%)  2/614 (0.33%) 
Chest Pain  1  2/623 (0.32%)  1/614 (0.16%) 
Chills  1  1/623 (0.16%)  0/614 (0.00%) 
Complication Associated With Device  1  0/623 (0.00%)  1/614 (0.16%) 
Death  1  3/623 (0.48%)  0/614 (0.00%) 
Fatigue  1  3/623 (0.48%)  4/614 (0.65%) 
General Physical Health Deterioration  1  3/623 (0.48%)  0/614 (0.00%) 
Malaise  1  0/623 (0.00%)  1/614 (0.16%) 
Mucosal Inflammation  1  1/623 (0.16%)  0/614 (0.00%) 
Multiple Organ Dysfunction Syndrome  1  0/623 (0.00%)  1/614 (0.16%) 
Non-Cardiac Chest Pain  1  0/623 (0.00%)  1/614 (0.16%) 
Oedema  1  0/623 (0.00%)  1/614 (0.16%) 
Oedema Peripheral  1  0/623 (0.00%)  1/614 (0.16%) 
Pain  1  0/623 (0.00%)  1/614 (0.16%) 
Pyrexia  1  7/623 (1.12%)  6/614 (0.98%) 
Sudden Death  1  1/623 (0.16%)  3/614 (0.49%) 
Hepatobiliary disorders     
Biliary Colic  1  1/623 (0.16%)  0/614 (0.00%) 
Immune system disorders     
Anaphylactic Shock  1  1/623 (0.16%)  0/614 (0.00%) 
Infections and infestations     
Abscess Limb  1  1/623 (0.16%)  0/614 (0.00%) 
Arthritis Bacterial  1  1/623 (0.16%)  0/614 (0.00%) 
Atypical Pneumonia  1  0/623 (0.00%)  1/614 (0.16%) 
Bronchitis  1  2/623 (0.32%)  2/614 (0.33%) 
Cellulitis  1  1/623 (0.16%)  1/614 (0.16%) 
Clostridium Colitis  1  0/623 (0.00%)  1/614 (0.16%) 
Conjunctivitis  1  1/623 (0.16%)  1/614 (0.16%) 
Diverticulitis  1  1/623 (0.16%)  0/614 (0.00%) 
Empyema  1  0/623 (0.00%)  1/614 (0.16%) 
Erysipelas  1  0/623 (0.00%)  1/614 (0.16%) 
Gastroenteritis  1  1/623 (0.16%)  0/614 (0.00%) 
Gastroenteritis Clostridial  1  1/623 (0.16%)  0/614 (0.00%) 
Genital Infection  1  0/623 (0.00%)  1/614 (0.16%) 
Hepatobiliary Infection  1  1/623 (0.16%)  0/614 (0.00%) 
Herpes Zoster  1  0/623 (0.00%)  1/614 (0.16%) 
Infection  1  1/623 (0.16%)  1/614 (0.16%) 
Infective Exacerbation Of Chronic Obstructive Airways Disease  1  2/623 (0.32%)  1/614 (0.16%) 
Lower Respiratory Tract Infection  1  7/623 (1.12%)  6/614 (0.98%) 
Lung Infection  1  1/623 (0.16%)  0/614 (0.00%) 
Mycobacterial Infection  1  1/623 (0.16%)  0/614 (0.00%) 
Neutropenic Infection  1  1/623 (0.16%)  0/614 (0.00%) 
Pleural Infection  1  0/623 (0.00%)  1/614 (0.16%) 
Pleural Infection Bacterial  1  0/623 (0.00%)  1/614 (0.16%) 
Pneumococcal Sepsis  1  0/623 (0.00%)  1/614 (0.16%) 
Pneumonia  1  27/623 (4.33%)  22/614 (3.58%) 
Pneumonia Haemophilus  1  0/623 (0.00%)  1/614 (0.16%) 
Pulmonary Sepsis  1  1/623 (0.16%)  0/614 (0.00%) 
Pulmonary Tuberculosis  1  2/623 (0.32%)  1/614 (0.16%) 
Pyelonephritis  1  0/623 (0.00%)  1/614 (0.16%) 
Respiratory Tract Infection  1  5/623 (0.80%)  4/614 (0.65%) 
Sepsis  1  1/623 (0.16%)  4/614 (0.65%) 
Septic Shock  1  1/623 (0.16%)  1/614 (0.16%) 
Streptococcal Bacteraemia  1  1/623 (0.16%)  0/614 (0.00%) 
Subcutaneous Abscess  1  1/623 (0.16%)  0/614 (0.00%) 
Urinary Tract Infection  1  6/623 (0.96%)  1/614 (0.16%) 
Viral Upper Respiratory Tract Infection  1  1/623 (0.16%)  0/614 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/623 (0.16%)  0/614 (0.00%) 
Femoral Neck Fracture  1  1/623 (0.16%)  0/614 (0.00%) 
Femur Fracture  1  2/623 (0.32%)  1/614 (0.16%) 
Gastroenteritis Radiation  1  0/623 (0.00%)  1/614 (0.16%) 
Head Injury  1  0/623 (0.00%)  1/614 (0.16%) 
Hip Fracture  1  1/623 (0.16%)  0/614 (0.00%) 
Humerus Fracture  1  0/623 (0.00%)  1/614 (0.16%) 
Overdose  1  1/623 (0.16%)  0/614 (0.00%) 
Post Procedural Haemorrhage  1  1/623 (0.16%)  0/614 (0.00%) 
Procedural Pain  1  0/623 (0.00%)  1/614 (0.16%) 
Radiation Injury  1  0/623 (0.00%)  1/614 (0.16%) 
Spinal Compression Fracture  1  2/623 (0.32%)  0/614 (0.00%) 
Subdural Haematoma  1  0/623 (0.00%)  1/614 (0.16%) 
Vascular Graft Occlusion  1  0/623 (0.00%)  1/614 (0.16%) 
Investigations     
Body Temperature Increased  1  0/623 (0.00%)  1/614 (0.16%) 
C-Reactive Protein Increased  1  0/623 (0.00%)  2/614 (0.33%) 
Electrocardiogram Qt Prolonged  1  2/623 (0.32%)  0/614 (0.00%) 
Electrocardiogram St-T Change  1  1/623 (0.16%)  0/614 (0.00%) 
Electrocardiogram T Wave Inversion  1  1/623 (0.16%)  0/614 (0.00%) 
International Normalised Ratio Increased  1  1/623 (0.16%)  0/614 (0.00%) 
Platelet Count Decreased  1  1/623 (0.16%)  0/614 (0.00%) 
Weight Decreased  1  0/623 (0.00%)  1/614 (0.16%) 
Metabolism and nutrition disorders     
Cachexia  1  0/623 (0.00%)  1/614 (0.16%) 
Decreased Appetite  1  3/623 (0.48%)  4/614 (0.65%) 
Dehydration  1  7/623 (1.12%)  4/614 (0.65%) 
Diabetes Mellitus  1  0/623 (0.00%)  1/614 (0.16%) 
Diabetes Mellitus Inadequate Control  1  0/623 (0.00%)  1/614 (0.16%) 
Hypercalcaemia  1  0/623 (0.00%)  1/614 (0.16%) 
Hypoglycaemia  1  2/623 (0.32%)  0/614 (0.00%) 
Hypokalaemia  1  2/623 (0.32%)  0/614 (0.00%) 
Hyponatraemia  1  3/623 (0.48%)  0/614 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/623 (0.00%)  3/614 (0.49%) 
Back Pain  1  1/623 (0.16%)  0/614 (0.00%) 
Bone Pain  1  1/623 (0.16%)  0/614 (0.00%) 
Muscular Weakness  1  1/623 (0.16%)  3/614 (0.49%) 
Musculoskeletal Chest Pain  1  3/623 (0.48%)  0/614 (0.00%) 
Neck Pain  1  1/623 (0.16%)  0/614 (0.00%) 
Pain In Extremity  1  0/623 (0.00%)  3/614 (0.49%) 
Spinal Pain  1  1/623 (0.16%)  0/614 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-Cell Small Lymphocytic Lymphoma  1  0/623 (0.00%)  1/614 (0.16%) 
Cancer Pain  1  3/623 (0.48%)  4/614 (0.65%) 
Lymphangiosis Carcinomatosa  1  1/623 (0.16%)  0/614 (0.00%) 
Malignant Pleural Effusion  1  1/623 (0.16%)  0/614 (0.00%) 
Prostate Cancer  1  1/623 (0.16%)  1/614 (0.16%) 
Nervous system disorders     
Altered State Of Consciousness  1  1/623 (0.16%)  1/614 (0.16%) 
Aphasia  1  1/623 (0.16%)  0/614 (0.00%) 
Ataxia  1  0/623 (0.00%)  1/614 (0.16%) 
Cerebral Infarction  1  0/623 (0.00%)  1/614 (0.16%) 
Cerebral Ischaemia  1  2/623 (0.32%)  0/614 (0.00%) 
Cerebral Thrombosis  1  1/623 (0.16%)  0/614 (0.00%) 
Cerebrovascular Accident  1  1/623 (0.16%)  3/614 (0.49%) 
Dizziness  1  3/623 (0.48%)  1/614 (0.16%) 
Dysarthria  1  0/623 (0.00%)  1/614 (0.16%) 
Headache  1  2/623 (0.32%)  0/614 (0.00%) 
Hemiparesis  1  1/623 (0.16%)  0/614 (0.00%) 
Lethargy  1  1/623 (0.16%)  0/614 (0.00%) 
Paralysis Recurrent Laryngeal Nerve  1  0/623 (0.00%)  1/614 (0.16%) 
Psychomotor Hyperactivity  1  0/623 (0.00%)  1/614 (0.16%) 
Seizure  1  7/623 (1.12%)  3/614 (0.49%) 
Somnolence  1  0/623 (0.00%)  2/614 (0.33%) 
Speech Disorder  1  0/623 (0.00%)  1/614 (0.16%) 
Spinal Cord Compression  1  0/623 (0.00%)  2/614 (0.33%) 
Syncope  1  1/623 (0.16%)  4/614 (0.65%) 
Product Issues     
Device Failure  1  1/623 (0.16%)  0/614 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/623 (0.16%)  0/614 (0.00%) 
Completed Suicide  1  1/623 (0.16%)  0/614 (0.00%) 
Confusional State  1  1/623 (0.16%)  4/614 (0.65%) 
Insomnia  1  0/623 (0.00%)  1/614 (0.16%) 
Mental Status Changes  1  1/623 (0.16%)  1/614 (0.16%) 
Renal and urinary disorders     
Acute Kidney Injury  1  0/623 (0.00%)  1/614 (0.16%) 
Calculus Urinary  1  0/623 (0.00%)  1/614 (0.16%) 
Hydronephrosis  1  1/623 (0.16%)  0/614 (0.00%) 
Nephrolithiasis  1  1/623 (0.16%)  1/614 (0.16%) 
Renal Failure  1  0/623 (0.00%)  1/614 (0.16%) 
Tubulointerstitial Nephritis  1  1/623 (0.16%)  0/614 (0.00%) 
Urinary Retention  1  1/623 (0.16%)  0/614 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acquired Tracheo-Oesophageal Fistula  1  1/623 (0.16%)  1/614 (0.16%) 
Acute Respiratory Failure  1  0/623 (0.00%)  1/614 (0.16%) 
Aspiration  1  0/623 (0.00%)  1/614 (0.16%) 
Asthmatic Crisis  1  0/623 (0.00%)  1/614 (0.16%) 
Atelectasis  1  0/623 (0.00%)  1/614 (0.16%) 
Bronchial Fistula  1  0/623 (0.00%)  1/614 (0.16%) 
Chronic Obstructive Pulmonary Disease  1  0/623 (0.00%)  1/614 (0.16%) 
Cough  1  4/623 (0.64%)  2/614 (0.33%) 
Dyspnoea  1  13/623 (2.09%)  20/614 (3.26%) 
Haemoptysis  1  1/623 (0.16%)  11/614 (1.79%) 
Hypoxia  1  0/623 (0.00%)  2/614 (0.33%) 
Interstitial Lung Disease  1  1/623 (0.16%)  0/614 (0.00%) 
Laryngeal Oedema  1  1/623 (0.16%)  0/614 (0.00%) 
Lung Infiltration  1  1/623 (0.16%)  0/614 (0.00%) 
Pleural Effusion  1  1/623 (0.16%)  2/614 (0.33%) 
Pleural Fibrosis  1  0/623 (0.00%)  1/614 (0.16%) 
Pleurisy  1  1/623 (0.16%)  0/614 (0.00%) 
Pneumonia Aspiration  1  2/623 (0.32%)  1/614 (0.16%) 
Pneumonitis  1  2/623 (0.32%)  3/614 (0.49%) 
Pneumothorax  1  0/623 (0.00%)  3/614 (0.49%) 
Pulmonary Embolism  1  8/623 (1.28%)  6/614 (0.98%) 
Pulmonary Haemorrhage  1  1/623 (0.16%)  0/614 (0.00%) 
Respiratory Distress  1  1/623 (0.16%)  0/614 (0.00%) 
Respiratory Failure  1  3/623 (0.48%)  0/614 (0.00%) 
Stridor  1  1/623 (0.16%)  0/614 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  0/623 (0.00%)  1/614 (0.16%) 
Angioedema  1  0/623 (0.00%)  1/614 (0.16%) 
Dermatitis Acneiform  1  0/623 (0.00%)  3/614 (0.49%) 
Dermatitis Exfoliative  1  2/623 (0.32%)  0/614 (0.00%) 
Eczema Asteatotic  1  1/623 (0.16%)  0/614 (0.00%) 
Erythema  1  1/623 (0.16%)  1/614 (0.16%) 
Erythema Multiforme  1  1/623 (0.16%)  0/614 (0.00%) 
Palmar-Plantar Erythrodysaesthesia Syndrome  1  1/623 (0.16%)  0/614 (0.00%) 
Photosensitivity Reaction  1  3/623 (0.48%)  1/614 (0.16%) 
Rash  1  7/623 (1.12%)  2/614 (0.33%) 
Rash Erythematous  1  1/623 (0.16%)  0/614 (0.00%) 
Rash Maculo-Papular  1  1/623 (0.16%)  0/614 (0.00%) 
Rash Papular  1  0/623 (0.00%)  2/614 (0.33%) 
Surgical and medical procedures     
Thoracotomy  1  0/623 (0.00%)  1/614 (0.16%) 
Vascular disorders     
Deep Vein Thrombosis  1  1/623 (0.16%)  5/614 (0.81%) 
Haematoma  1  0/623 (0.00%)  1/614 (0.16%) 
Hypertension  1  3/623 (0.48%)  1/614 (0.16%) 
Hypertensive Crisis  1  1/623 (0.16%)  0/614 (0.00%) 
Hypotension  1  0/623 (0.00%)  3/614 (0.49%) 
Hypovolaemic Shock  1  0/623 (0.00%)  1/614 (0.16%) 
Jugular Vein Thrombosis  1  0/623 (0.00%)  1/614 (0.16%) 
Orthostatic Hypotension  1  0/623 (0.00%)  1/614 (0.16%) 
Peripheral Arterial Occlusive Disease  1  1/623 (0.16%)  0/614 (0.00%) 
Peripheral Ischaemia  1  1/623 (0.16%)  0/614 (0.00%) 
Subclavian Vein Thrombosis  1  1/623 (0.16%)  1/614 (0.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 20.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   539/623 (86.52%)   542/614 (88.27%) 
Gastrointestinal disorders     
Constipation  1  58/623 (9.31%)  87/614 (14.17%) 
Diarrhoea  1  300/623 (48.15%)  232/614 (37.79%) 
Dyspepsia  1  29/623 (4.65%)  31/614 (5.05%) 
Nausea  1  138/623 (22.15%)  131/614 (21.34%) 
Stomatitis  1  33/623 (5.30%)  33/614 (5.37%) 
Vomiting  1  85/623 (13.64%)  91/614 (14.82%) 
General disorders     
Asthenia  1  50/623 (8.03%)  59/614 (9.61%) 
Fatigue  1  119/623 (19.10%)  109/614 (17.75%) 
Oedema Peripheral  1  21/623 (3.37%)  34/614 (5.54%) 
Pyrexia  1  44/623 (7.06%)  50/614 (8.14%) 
Infections and infestations     
Paronychia  1  12/623 (1.93%)  31/614 (5.05%) 
Investigations     
Weight Decreased  1  33/623 (5.30%)  29/614 (4.72%) 
Metabolism and nutrition disorders     
Anorexia  1  114/623 (18.30%)  123/614 (20.03%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  37/623 (5.94%)  40/614 (6.51%) 
Musculoskeletal Chest Pain  1  33/623 (5.30%)  24/614 (3.91%) 
Nervous system disorders     
Dizziness  1  37/623 (5.94%)  40/614 (6.51%) 
Headache  1  55/623 (8.83%)  40/614 (6.51%) 
Psychiatric disorders     
Insomnia  1  59/623 (9.47%)  40/614 (6.51%) 
Renal and urinary disorders     
Proteinuria  1  33/623 (5.30%)  8/614 (1.30%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  78/623 (12.52%)  92/614 (14.98%) 
Dyspnoea  1  84/623 (13.48%)  70/614 (11.40%) 
Haemoptysis  1  31/623 (4.98%)  39/614 (6.35%) 
Skin and subcutaneous tissue disorders     
Acne  1  45/623 (7.22%)  50/614 (8.14%) 
Dermatitis Acneiform  1  75/623 (12.04%)  103/614 (16.78%) 
Dry Skin  1  60/623 (9.63%)  84/614 (13.68%) 
Pruritus  1  38/623 (6.10%)  67/614 (10.91%) 
Rash  1  169/623 (27.13%)  232/614 (37.79%) 
Vascular disorders     
Hypertension  1  99/623 (15.89%)  14/614 (2.28%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 20.0
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: NCT00364351     History of Changes
Other Study ID Numbers: D4200C00057
EUDRACT No. 2006-000259-16
First Submitted: August 14, 2006
First Posted: August 15, 2006
Results First Submitted: April 27, 2011
Results First Posted: May 24, 2011
Last Update Posted: January 25, 2018