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An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

Sponsor
Genzyme, a Sanofi Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT00410761
Collaborator
(none)
437
Enrollment
66
Locations
2
Arms
193
Anticipated Duration (Months)
6.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.

Condition or Disease Intervention/Treatment Phase
  • Drug: ZD6474 (Vandetanib)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
437 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer
Actual Study Start Date :
Nov 30, 2006
Actual Primary Completion Date :
Jul 31, 2009
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 1

Placebo vandetanib
Experimental: 2

Vandetanib

Drug: ZD6474 (Vandetanib)
once daily oral tablet
Other Names:
  • ZACTIMA™
  • SAR390530

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival(PFS) [RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.]

      Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) [RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.]

      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 defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE.

    2. Disease Control Rate (DCR) [RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent]

      Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 12 weeks

    3. Duration of Response (DoR) [RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent]

      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). Values are estimated as the medians weren't met

    4. Overall Survival (OS) [Number of deaths since randomisation]

      As data was immature at data cut off, number of death events is quoted

    5. Biochemical Response Calcitonin (CTN) [Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up]

      Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.

    6. Biochemical Response Carcinoembryonic Antigen (CEA) [Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up]

      Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.

    7. Time to Worsening of Pain (TWP) [During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.]

      TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer.

    • Presence of measurable tumor

    • Able to swallow medication

    Exclusion Criteria:

    • Major surgery within 4 weeks before randomization

    • Last dose of prior chemotherapy received less than 4 weeks prior to randomization

    • Radiation therapy within the last 4 weeks prior to randomization(with exception of palliative radiotherapy)

    • Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days

    • Significant cardiac events

    • Previous ZD6474 treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 3 Little Rock Arkansas United States 72205
    2 Investigational Site Number 8 San Francisco California United States 94115
    3 Investigational Site Number 9 Aurora Colorado United States 80010
    4 Investigational Site Number 11 New Haven Connecticut United States 06510
    5 Investigational Site Number 15 Jacksonville Florida United States 32224
    6 Investigational Site Number 18 Chicago Illinois United States 60637
    7 Investigational Site Number 17 Lexington Kentucky United States 40536-0298
    8 Investigational Site Number 2 Boston Massachusetts United States 02115
    9 Investigational Site Number 7 Detroit Michigan United States 48201
    10 Investigational Site Number 14 Rochester Minnesota United States 55905
    11 Investigational Site Number 10 Saint Louis Missouri United States 63110
    12 Investigational Site Number 6 Cincinnati Ohio United States 45267-0589
    13 Investigational Site Number 22 Portland Oregon United States 97239
    14 Investigational Site Number 19 Charleston South Carolina United States 29425
    15 Investigational Site Number 13 Houston Texas United States 77030
    16 Investigational Site Number 21 Burlington Vermont United States 05401
    17 Investigational Site Number 1001 St Leonards Australia 2065
    18 Investigational Site Number 1901 Wien Austria 1901
    19 Investigational Site Number 1101 Bruxelles Belgium 1000
    20 Investigational Site Number 1102 Leuven Belgium 3000
    21 Investigational Site Number 2301 Porto Alegre Brazil 90035-003
    22 Investigational Site Number 2302 Ribeirão Preto Brazil 14048-900
    23 Investigational Site Number 1203 Calgary Canada T2E7C5
    24 Investigational Site Number 1202 London Canada N6A 4L6
    25 Investigational Site Number 1201 Moncton Canada E1C6Z8
    26 Investigational Site Number 1204 Sherbrooke Canada J1H 5N4
    27 Investigational Site Number 1205 Toronto Canada M5G2M9
    28 Investigational Site Number 3601 Praha 5 Czechia 15006
    29 Investigational Site Number 2701 Odense C Denmark 5000
    30 Investigational Site Number 2802 BORDEAUX Cedex France 33076
    31 Investigational Site Number 2803 LYON Cedex 8 France 69373
    32 Investigational Site Number 2801 Villejuif France 94800
    33 Investigational Site Number 2002 Essen Germany 45122
    34 Investigational Site Number 2001 Halle Germany 06120
    35 Investigational Site Number 2005 Würzburg Germany 97080
    36 Investigational Site Number 1601 Pécs Hungary 7624
    37 Investigational Site Number 1401 Mumbai India 400012
    38 Investigational Site Number 1402 Vellore India 632004
    39 Investigational Site Number 2506 Catania Italy
    40 Investigational Site Number 2502 Milano Italy
    41 Investigational Site Number 2503 Napoli Italy 80131
    42 Investigational Site Number 2501 Pisa Italy 56124
    43 Investigational Site Number 2505 Roma Italy 00161
    44 Investigational Site Number 2504 Siena Italy 53100
    45 Investigational Site Number 1501 Seoul Korea, Republic of
    46 Investigational Site Number 2403 Cd. Madero Mexico
    47 Investigational Site Number 2402 Mexico City Mexico 14000
    48 Investigational Site Number 2404 México Mexico 06726
    49 Investigational Site Number 2902 Groningen Netherlands
    50 Investigational Site Number 2901 Utrecht Netherlands
    51 Investigational Site Number 1701 Gliwice Poland 44-101
    52 Investigational Site Number 1702 Poznan Poland 60-355
    53 Investigational Site Number 1703 Warszawa Poland 02-781
    54 Investigational Site Number 2602 Coimbra Portugal 3000-75
    55 Investigational Site Number 2601 Lisboa Portugal 1099-023
    56 Investigational Site Number 1801 Bucarest Romania
    57 Investigational Site Number 3301 Obninsk Russian Federation 249036
    58 Investigational Site Number 3402 Belgrade Serbia
    59 Investigational Site Number 3401 Belgrad Serbia 11000
    60 Investigational Site Number 3003 Madrid Spain 28040
    61 Investigational Site Number 3001 Madrid Spain 28041
    62 Investigational Site Number 3002 Pamplona Spain 31008
    63 Investigational Site Number 3102 Stockholm Sweden 17176
    64 Investigational Site Number 3101 Uppsala Sweden 75185
    65 Investigational Site Number 2101 Basel Switzerland 4031
    66 Investigational Site Number 2102 Bern Switzerland CH-3010

    Sponsors and Collaborators

    • Genzyme, a Sanofi Company

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Genzyme, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00410761
    Other Study ID Numbers:
    • D4200C00058
    • 2005-005077-29
    • LPS14811
    First Posted:
    Dec 13, 2006
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by Genzyme, a Sanofi Company
    ZD6474
    MTC
    Hereditary Medullary Thyroid Cancer
    Sporadic Medullary Thyroid Cancer
    Medullary Thyroid Cancer
    Additional relevant MeSH terms:
    Thyroid Neoplasms
    Carcinoma, Neuroendocrine
    Thyroid Diseases

    Study Results

    Participant Flow

    Recruitment Details First patient enrolled 23 November 2006, last patient enrolled 19 October 2007, cut off date 31 July 2009. 437 patients were enrolled.
    Pre-assignment Detail
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    Period Title: Overall Study
    STARTED 231 100
    COMPLETED 111 28
    NOT COMPLETED 120 72

    Baseline Characteristics

    Arm/Group Title Vandetanib 300 mg Placebo Total
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily Total of all reporting groups
    Overall Participants 231 100 331
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    50.7
    53.4
    52
    Sex: Female, Male (Count of Participants)
    Female
    97
    42%
    44
    44%
    141
    42.6%
    Male
    134
    58%
    56
    56%
    190
    57.4%

    Outcome Measures

    1. Primary Outcome
    Title Progression-Free Survival(PFS)
    Description Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.
    Time Frame RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    Measure Participants 231 100
    Median (95% Confidence Interval) [Months]
    30.5
    19.2
    2. Secondary Outcome
    Title Objective Response Rate (ORR)
    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 defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)>= 12 weeks, progressive disease (PD) or NE.
    Time Frame RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    Measure Participants 231 100
    Number [Participants]
    104
    45%
    13
    13%
    3. Secondary Outcome
    Title Disease Control Rate (DCR)
    Description Disease control rate is defined as the number of patients who achieved disease control at 8 weeks following randomisation. Disease control at 8 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 12 weeks
    Time Frame RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    Measure Participants 231 100
    Number [Participants]
    200
    86.6%
    71
    71%
    4. Secondary Outcome
    Title Duration of Response (DoR)
    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). Values are estimated as the medians weren't met
    Time Frame RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent

    Outcome Measure Data

    Analysis Population Description
    DoR is a time to event endpoint and because the medians were not met in this study there is no appropriate measure of dispersion of the median
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    Measure Participants 104 13
    Median (95% Confidence Interval) [Months]
    22.2
    16.3
    5. Secondary Outcome
    Title Overall Survival (OS)
    Description As data was immature at data cut off, number of death events is quoted
    Time Frame Number of deaths since randomisation

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    Measure Participants 231 100
    Number [Participants]
    32
    13.9%
    16
    16%
    6. Secondary Outcome
    Title Biochemical Response Calcitonin (CTN)
    Description Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CTN.
    Time Frame Blood samples Blood samples for analysis of CTN were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    Measure Participants 231 100
    Number [Participants]
    160
    69.3%
    3
    3%
    7. Secondary Outcome
    Title Biochemical Response Carcinoembryonic Antigen (CEA)
    Description Best biochemical response was calculated from assessments at baseline and during treatment. Responders were those patients with a best biochemical response of CR or PR, confirmed by repeat assessments, which were to be performed no less than 4 weeks after the criteria for PR or CR were first met. CR and PR being defined according to level of CEA.
    Time Frame Blood samples for analysis of CEA were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    Measure Participants 231 100
    Number [Participants]
    119
    51.5%
    2
    2%
    8. Secondary Outcome
    Title Time to Worsening of Pain (TWP)
    Description TWP was derived using the worst pain score from brief pain inventory (BPI) and patient reported opioid analgesic use. BPI uses 0 to 10 numeric rating scales asking subjects to rate their pain.
    Time Frame During the last week of the screening period (Day -7 to Day 0), the brief pain inventory (BPI) and opioid analgesic use were self-reported once a day for 4 days to establish baseline, then every week during blinded study treatment, up to discontinuation.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    Measure Participants 231 100
    Number [Weeks]
    7.8
    3.3

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Vandetanib 300 mg Placebo
    Arm/Group Description Vandetanib (300 mg daily) Placebo daily
    All Cause Mortality
    Vandetanib 300 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Vandetanib 300 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 71/231 (30.7%) 13/99 (13.1%)
    Blood and lymphatic system disorders
    Thrombocytopenia 1/231 (0.4%) 0/99 (0%)
    Cardiac disorders
    Arrhythmia 1/231 (0.4%) 0/99 (0%)
    Atrial Fibrillation 1/231 (0.4%) 0/99 (0%)
    Bradycardia 1/231 (0.4%) 0/99 (0%)
    Cardiac Failure Acute 1/231 (0.4%) 0/99 (0%)
    Pericardial Effusion 0/231 (0%) 1/99 (1%)
    Pericardial Haemorrhage 0/231 (0%) 1/99 (1%)
    Pericarditis 1/231 (0.4%) 0/99 (0%)
    Eye disorders
    Glaucoma 1/231 (0.4%) 0/99 (0%)
    Vision Blurred 1/231 (0.4%) 0/99 (0%)
    Gastrointestinal disorders
    Diarrhoea 5/231 (2.2%) 0/99 (0%)
    Abdominal Pain 3/231 (1.3%) 0/99 (0%)
    Dysphagia 2/231 (0.9%) 0/99 (0%)
    Vomiting 2/231 (0.9%) 0/99 (0%)
    Colitis 1/231 (0.4%) 0/99 (0%)
    Gastritis 1/231 (0.4%) 0/99 (0%)
    Gastrointestinal Haemorrhage 1/231 (0.4%) 1/99 (1%)
    Ileus 1/231 (0.4%) 0/99 (0%)
    Pancreatitis 1/231 (0.4%) 0/99 (0%)
    Peritonitis 1/231 (0.4%) 0/99 (0%)
    Pneumatosis Intestinalis 1/231 (0.4%) 0/99 (0%)
    Small Intestinal Perforation 1/231 (0.4%) 0/99 (0%)
    General disorders
    Asthenia 2/231 (0.9%) 0/99 (0%)
    Chest Pain 1/231 (0.4%) 0/99 (0%)
    Fatigue 1/231 (0.4%) 1/99 (1%)
    General Physical Health Deterioration 1/231 (0.4%) 1/99 (1%)
    Mucosal Inflammation 1/231 (0.4%) 0/99 (0%)
    Hepatobiliary disorders
    Cholecystitis 1/231 (0.4%) 0/99 (0%)
    Cholelithiasis 1/231 (0.4%) 0/99 (0%)
    Immune system disorders
    Iodine Allergy 0/231 (0%) 1/99 (1%)
    Infections and infestations
    Pneumonia 5/231 (2.2%) 0/99 (0%)
    Urinary Tract Infection 3/231 (1.3%) 0/99 (0%)
    Appendicitis 2/231 (0.9%) 0/99 (0%)
    Bronchitis 2/231 (0.9%) 1/99 (1%)
    Diverticulitis 2/231 (0.9%) 0/99 (0%)
    Sepsis 2/231 (0.9%) 0/99 (0%)
    Abdominal Wall Abscess 1/231 (0.4%) 0/99 (0%)
    Gastroenteritis 0/231 (0%) 1/99 (1%)
    Gastroenteritis Bacterial 1/231 (0.4%) 0/99 (0%)
    Gastroenteritis Viral 1/231 (0.4%) 0/99 (0%)
    Infected Bites 1/231 (0.4%) 0/99 (0%)
    Laryngitis 1/231 (0.4%) 0/99 (0%)
    Pyelonephritis 1/231 (0.4%) 0/99 (0%)
    Staphylococcal Infection 1/231 (0.4%) 0/99 (0%)
    Staphylococcal Sepsis 1/231 (0.4%) 0/99 (0%)
    Tracheitis 1/231 (0.4%) 0/99 (0%)
    Injury, poisoning and procedural complications
    Jaw Fracture 0/231 (0%) 1/99 (1%)
    Joint Injury 1/231 (0.4%) 0/99 (0%)
    Overdose 0/231 (0%) 1/99 (1%)
    Stent Occlusion 1/231 (0.4%) 0/99 (0%)
    Venomous Bite 1/231 (0.4%) 0/99 (0%)
    C-Reactive Protein Increased 1/231 (0.4%) 0/99 (0%)
    Electrocardiogram Qt Prolonged 1/231 (0.4%) 0/99 (0%)
    International Normalised Ratio Increased 1/231 (0.4%) 0/99 (0%)
    Prostatic Specific Antigen Increased 0/231 (0%) 1/99 (1%)
    Metabolism and nutrition disorders
    Decreased Appetite 4/231 (1.7%) 0/99 (0%)
    Hypercalcaemia 3/231 (1.3%) 0/99 (0%)
    Dehydration 2/231 (0.9%) 0/99 (0%)
    Hypocalcaemia 2/231 (0.9%) 0/99 (0%)
    Hypokalaemia 2/231 (0.9%) 0/99 (0%)
    Diabetes Mellitus 0/231 (0%) 1/99 (1%)
    Hypoglycaemia 1/231 (0.4%) 0/99 (0%)
    Hyponatraemia 1/231 (0.4%) 0/99 (0%)
    Malnutrition 1/231 (0.4%) 0/99 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma 0/231 (0%) 1/99 (1%)
    Metastases To Bone 1/231 (0.4%) 0/99 (0%)
    Phaeochromocytoma 0/231 (0%) 1/99 (1%)
    Nervous system disorders
    Loss Of Consciousness 2/231 (0.9%) 0/99 (0%)
    Transient Ischaemic Attack 2/231 (0.9%) 0/99 (0%)
    Brain Oedema 1/231 (0.4%) 0/99 (0%)
    Cerebral Ischaemia 1/231 (0.4%) 0/99 (0%)
    Depressed Level Of Consciousness 1/231 (0.4%) 0/99 (0%)
    Hemiparesis 0/231 (0%) 1/99 (1%)
    Neuralgia 0/231 (0%) 1/99 (1%)
    Peripheral Sensorimotor Neuropathy 1/231 (0.4%) 0/99 (0%)
    Psychiatric disorders
    Depression 3/231 (1.3%) 0/99 (0%)
    Bipolar Disorder 1/231 (0.4%) 0/99 (0%)
    Renal and urinary disorders
    Nephrolithiasis 2/231 (0.9%) 0/99 (0%)
    Anuria 1/231 (0.4%) 0/99 (0%)
    Calculus Ureteric 1/231 (0.4%) 0/99 (0%)
    Renal Colic 1/231 (0.4%) 0/99 (0%)
    Renal Failure 1/231 (0.4%) 0/99 (0%)
    Tubulointerstitial Nephritis 1/231 (0.4%) 0/99 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis 2/231 (0.9%) 0/99 (0%)
    Bronchospasm 1/231 (0.4%) 0/99 (0%)
    Chylothorax 1/231 (0.4%) 0/99 (0%)
    Dyspnoea 1/231 (0.4%) 0/99 (0%)
    Haemoptysis 1/231 (0.4%) 1/99 (1%)
    Pleural Effusion 0/231 (0%) 1/99 (1%)
    Pneumonia Aspiration 1/231 (0.4%) 0/99 (0%)
    Pulmonary Thrombosis 0/231 (0%) 1/99 (1%)
    Respiratory Arrest 1/231 (0.4%) 0/99 (0%)
    Respiratory Failure 1/231 (0.4%) 0/99 (0%)
    Skin and subcutaneous tissue disorders
    Photosensitivity Reaction 2/231 (0.9%) 0/99 (0%)
    Pruritus 1/231 (0.4%) 0/99 (0%)
    Rash 1/231 (0.4%) 0/99 (0%)
    Skin Ulcer 1/231 (0.4%) 0/99 (0%)
    Vascular disorders
    Hypertensive Crisis 4/231 (1.7%) 0/99 (0%)
    Hypertension 3/231 (1.3%) 0/99 (0%)
    Accelerated Hypertension 1/231 (0.4%) 0/99 (0%)
    Pelvic Venous Thrombosis 1/231 (0.4%) 0/99 (0%)
    Vena Cava Thrombosis 1/231 (0.4%) 0/99 (0%)
    Other (Not Including Serious) Adverse Events
    Vandetanib 300 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 230/231 (99.6%) 90/99 (90.9%)
    Endocrine disorders
    Hypothyroidism 15/231 (6.5%) 0/99 (0%)
    Eye disorders
    Vision Blurred 19/231 (8.2%) 1/99 (1%)
    Gastrointestinal disorders
    Diarrhoea 128/231 (55.4%) 26/99 (26.3%)
    Nausea 77/231 (33.3%) 16/99 (16.2%)
    Vomiting 33/231 (14.3%) 7/99 (7.1%)
    Abdominal Pain 31/231 (13.4%) 5/99 (5.1%)
    Dyspepsia 25/231 (10.8%) 4/99 (4%)
    Abdominal Pain Upper 20/231 (8.7%) 5/99 (5.1%)
    Dry Mouth 20/231 (8.7%) 3/99 (3%)
    Constipation 13/231 (5.6%) 5/99 (5.1%)
    Toothache 7/231 (3%) 5/99 (5.1%)
    General disorders
    Fatigue 54/231 (23.4%) 22/99 (22.2%)
    Asthenia 33/231 (14.3%) 11/99 (11.1%)
    Pyrexia 17/231 (7.4%) 3/99 (3%)
    Infections and infestations
    Nasopharyngitis 26/231 (11.3%) 9/99 (9.1%)
    Upper Respiratory Tract Infection 19/231 (8.2%) 3/99 (3%)
    Influenza 16/231 (6.9%) 3/99 (3%)
    Urinary Tract Infection 15/231 (6.5%) 6/99 (6.1%)
    Bronchitis 10/231 (4.3%) 6/99 (6.1%)
    Electrocardiogram Qt Prolonged 32/231 (13.9%) 1/99 (1%)
    Weight Decreased 24/231 (10.4%) 9/99 (9.1%)
    Metabolism and nutrition disorders
    Decreased Appetite 46/231 (19.9%) 12/99 (12.1%)
    Hypocalcaemia 23/231 (10%) 3/99 (3%)
    Musculoskeletal and connective tissue disorders
    Back Pain 21/231 (9.1%) 20/99 (20.2%)
    Arthralgia 18/231 (7.8%) 10/99 (10.1%)
    Musculoskeletal Chest Pain 16/231 (6.9%) 5/99 (5.1%)
    Pain In Extremity 16/231 (6.9%) 13/99 (13.1%)
    Muscle Spasms 15/231 (6.5%) 1/99 (1%)
    Neck Pain 14/231 (6.1%) 8/99 (8.1%)
    Musculoskeletal Pain 12/231 (5.2%) 9/99 (9.1%)
    Nervous system disorders
    Headache 59/231 (25.5%) 9/99 (9.1%)
    Dizziness 20/231 (8.7%) 6/99 (6.1%)
    Dysgeusia 19/231 (8.2%) 3/99 (3%)
    Paraesthesia 12/231 (5.2%) 3/99 (3%)
    Psychiatric disorders
    Insomnia 30/231 (13%) 10/99 (10.1%)
    Depression 19/231 (8.2%) 3/99 (3%)
    Anxiety 13/231 (5.6%) 5/99 (5.1%)
    Renal and urinary disorders
    Proteinuria 23/231 (10%) 2/99 (2%)
    Respiratory, thoracic and mediastinal disorders
    Cough 25/231 (10.8%) 10/99 (10.1%)
    Oropharyngeal Pain 19/231 (8.2%) 6/99 (6.1%)
    Dyspnoea 18/231 (7.8%) 9/99 (9.1%)
    Epistaxis 18/231 (7.8%) 5/99 (5.1%)
    Dysphonia 15/231 (6.5%) 3/99 (3%)
    Dyspnoea Exertional 3/231 (1.3%) 5/99 (5.1%)
    Skin and subcutaneous tissue disorders
    Rash 103/231 (44.6%) 11/99 (11.1%)
    Acne 46/231 (19.9%) 5/99 (5.1%)
    Dermatitis Acneiform 35/231 (15.2%) 2/99 (2%)
    Dry Skin 35/231 (15.2%) 5/99 (5.1%)
    Photosensitivity Reaction 29/231 (12.6%) 0/99 (0%)
    Pruritus 24/231 (10.4%) 4/99 (4%)
    Erythema 23/231 (10%) 3/99 (3%)
    Alopecia 18/231 (7.8%) 0/99 (0%)
    Vascular disorders
    Hypertension 72/231 (31.2%) 5/99 (5.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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
    Phone
    Email Contact-US@sanofi.com
    Responsible Party:
    Genzyme, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00410761
    Other Study ID Numbers:
    • D4200C00058
    • 2005-005077-29
    • LPS14811
    First Posted:
    Dec 13, 2006
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021