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ENTHUSE M1C: A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00617669
Collaborator
(none)
1,494
Enrollment
147
Locations
2
Arms
42
Duration (Months)
10.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.

All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.

Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1494 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Placebo + Docetaxel

placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Drug: Docetaxel
intravenous infusion given every three weeks
Other Names:
  • Taxotere®

    • Drug: Placebo
    placebo oral tablet once daily
    Experimental: ZD4054 + Docetaxel

    ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks

    Drug: Docetaxel
    intravenous infusion given every three weeks
    Other Names:
  • Taxotere®

    • Drug: ZD4054
    10 mg oral once daily dose
    Other Names:
  • Zibotentan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [Patients were followed for survival up to 40 months]

      Median time (in months) from randomisation until death using the Kaplan-Meier method.

    Secondary Outcome Measures

    1. Progression Free Survival [Patients were followed for progression up to 40 months]

      Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline

    2. Incidence of Skeletal Related Events [While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)]

      Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.

    3. Time to Prostate-specific Antigen (PSA) Progression [While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)]

      Median time (in months) from randomisation until first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.

    4. Time to Pain Progression [While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)]

      Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.

    5. Pain Response [While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)]

      Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.

    6. Health Related Quality of Life [While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)]

      Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.

    7. PSA Response [While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)]

      PSA response defined as >50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.

    Eligibility Criteria

    Criteria

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

    Patients who answer TRUE to the following criteria may be eligible to participate in this trial.

    • Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)

    • Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment

    • Currently receiving treatment with surgical or medical castration

    Exclusion Criteria:

    Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.

    • Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial.

    • Suffering from heart failure or had a myocardial infarction within last 6 months

    • A history of epilepsy or seizures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Greenbrae California United States
    2 Research Site San Diego California United States
    3 Research Site Norwich Connecticut United States
    4 Research Site Washington District of Columbia United States
    5 Research Site Fort Myers Florida United States
    6 Research Site Gainsville Florida United States
    7 Research Site Ocala Florida United States
    8 Research Site PORTUGALt St. Lucie Florida United States
    9 Research Site Rockville Maryland United States
    10 Research Site Minneapolis Minnesota United States
    11 Research Site Lincoln Nebraska United States
    12 Research Site Omaha Nebraska United States
    13 Research Site Chapel Hill North Carolina United States
    14 Research Site Durham North Carolina United States
    15 Research Site Winston-Salem North Carolina United States
    16 Research Site Canton Ohio United States
    17 Research Site Cincinnati Ohio United States
    18 Research Site Pittsburgh Pennsylvania United States
    19 Research Site Charleston South Carolina United States
    20 Research Site Chattanooga Tennessee United States
    21 Research Site Nashville Tennessee United States
    22 Research Site San Antonio Texas United States
    23 Research Site Richmond Virginia United States
    24 Research Site Seattle Washington United States
    25 Research Site Milwaukee Wisconsin United States
    26 Research Site Bahia Blanca Buenos Aires Argentina
    27 Research Site Buenos Aires Argentina
    28 Research Site Santa Fe Argentina
    29 Research Site Darlinghurst New South Wales Australia
    30 Research Site St Leonards New South Wales Australia
    31 Research Site Wollongong New South Wales Australia
    32 Research Site Redcliffe Queensland Australia
    33 Research Site Ashford South Australia Australia
    34 Research Site Footscray Victoria Australia
    35 Research Site Wodonga Victoria Australia
    36 Research Site Perth Western Australia Australia
    37 Research Site Subiaco Western Australia Australia
    38 Research Site Fortaleza Ceara/ LA Brazil
    39 Research Site Goiania Goias/ LA Brazil
    40 Research Site Goiania Goias Brazil
    41 Research Site Belo Horizonte Minas GERMANYais Brazil
    42 Research Site Curitiba Parana/ Brazil Brazil
    43 Research Site Londrina PR Brazil
    44 Research Site PORTUGALto Alegre Rio Grande do Sul/ LA Brazil
    45 Research Site Rio de Janeiro RJ Brazil
    46 Research Site Ribeirao Preto Sao Paulo/ LA Brazil
    47 Research Site Santo Andre Sao Paulo Brazil
    48 Research Site Sao Paulo Brazil
    49 Research Site Winnipeg Manitoba Canada
    50 Research Site Halifax Nova Scotia Canada
    51 Research Site London Ontario Canada
    52 Research Site Toronto Ontario Canada
    53 Research Site Quebec City Quebec Canada
    54 Research Site Sherbrooke Quebec Canada
    55 Research Site Brno CZECHOSLOVAKIA Republic Czech Republic
    56 Research Site Jablonec nad Nisou Czech Republic
    57 Research Site Kromeriz Czech Republic
    58 Research Site Olomouc Czech Republic
    59 Research Site Prague 2 Czech Republic
    60 Research Site Prague 6 Czech Republic
    61 Research Site Usti nad Labem Czech Republic
    62 Research Site Helsinki Finland
    63 Research Site Joensuu Finland
    64 Research Site Seinajoki Finland
    65 Research Site La Roche sur Yon FRANCEnce France
    66 Research Site Marseille FRANCEnce France
    67 Research Site Paris FRANCEnce France
    68 Research Site Reims FRANCEnce France
    69 Research Site Villejuif FRANCEnce France
    70 Research Site Paris France
    71 Research Site Saint Herblain France
    72 Research Site Hannover GERMANYmany Germany
    73 Research Site Berlin Germany
    74 Research Site Bonn Germany
    75 Research Site Dresden Germany
    76 Research Site Emmendingen Germany
    77 Research Site Kirchheim-Teck Germany
    78 Research Site Leipzig Germany
    79 Research Site Luebeck Germany
    80 Research Site Muenster Germany
    81 Research Site Tuebingen Germany
    82 Research Site Wuppertal Germany
    83 Research Site Budapest HUNGARYary Hungary
    84 Research Site Gyor HUNGARYary Hungary
    85 Research Site Miskolc HUNGARYary Hungary
    86 Research Site Ny Regyh Za HUNGARYary Hungary
    87 Research Site Szeged HUNGARYary Hungary
    88 Research Site Bangalore Karnataka India
    89 Research Site Trivandrum Kerala India
    90 Research Site Bhopal Madhya Pradesh India
    91 Research Site Pune Maharashtra India
    92 Research Site Bikaner Rajasthan India
    93 Research Site Jaipur Rajasthan India
    94 Research Site Vellore Tamil Nadu India
    95 Research Site Kolkata West Bengal India
    96 Research Site Kolkota West Bengal India
    97 Research Site Delhi India
    98 Research Site New Delhi India
    99 Research Site Genoa Italy
    100 Research Site Lugo (RA) Italy
    101 Research Site Rome Italy
    102 Research Site Cheongju Chungbuk Korea, Republic of
    103 Research Site Ilsandong-gu, Goyang-si Gyeonggi-do Korea, Republic of
    104 Research Site Nowon-gu Seoul Korea, Republic of
    105 Research Site Seodaemun-gu Seoul Korea, Republic of
    106 Research Site Songpa-gu Seoul Korea, Republic of
    107 Research Site Nijmegen Netherlands
    108 Research Site Cercado de Arequipa Arequipa Peru
    109 Research Site Cercado Arequipa Peru
    110 Research Site Callao Peru
    111 Research Site Lima Peru
    112 Research Site Lublin POLANDand Poland
    113 Research Site Swidnica POLANDand Poland
    114 Research Site Warszaa POLANDand Poland
    115 Research Site Koscierzyna Poland
    116 Research Site Wroclaw Poland
    117 Research Site Coimbra PORTUGALtugal Portugal
    118 Research Site PORTUGALto PORTUGALtugal Portugal
    119 Research Site Bucharest Romania
    120 Research Site Sibiu Romania
    121 Research Site Timisoara Romania
    122 Research Site Barnaul RUSSIAsia Russian Federation
    123 Research Site Izhevsk RUSSIAsia Russian Federation
    124 Research Site Kursk RUSSIAsia Russian Federation
    125 Research Site Sochi RUSSIAsia Russian Federation
    126 Research Site Voronezh RUSSIAsia Russian Federation
    127 Research Site Belgrade SERBIAbia Serbia
    128 Research Site Beograd SERBIAbia Serbia
    129 Research Site Nis SERBIAbia Serbia
    130 Research Site Panorama Cape Town South Africa
    131 Research Site TyGERberg Cape Town South Africa
    132 Research Site Overport Durban South Africa
    133 Research Site Bloemfontein South Africa
    134 Research Site PORt Elizabeth South Africa
    135 Research Site Madrid Spain
    136 Research Site Valencia Spain
    137 Research Site Stockholm Sweden
    138 Research Site Uppsala Sweden
    139 Research Site Aarau Switzerland
    140 Research Site Locarno Switzerland
    141 Research Site Sursee Switzerland
    142 Research Site Kaohsiung TAIWANwan Taiwan
    143 Research Site TAIWANpei TAIWANwan Taiwan
    144 Research Site Reading Berkshire United Kingdom
    145 Research Site Westgate Road Newcastle Upon Tyne United Kingdom
    146 Research Site London United Kingdom
    147 Research Site Manchester United Kingdom

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: Karim Fizazi, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris
    • Principal Investigator: Judd W Moul, MD, FACS, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00617669
    Other Study ID Numbers:
    • D4320C00033
    First Posted:
    Feb 18, 2008
    Last Update Posted:
    Sep 10, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by AstraZeneca
    Hormone Resistant Prostate Cancer
    Endothelin A Receptor Antagonist
    Endothelin A
    Endothelin A antagonist
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Docetaxel

    Study Results

    Participant Flow

    Recruitment Details 1494 patients with hormone resistant prostate cancer patients and bone metastasis were recruited between 24th January 2008 and 10th May 2011
    Pre-assignment Detail 442 of the 1494 enrolled patients were not randomised to treatment groups as they failed screening.
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    Period Title: Overall Study
    STARTED 524 528
    Patients Who Received IP 522 525
    COMPLETED 94 77
    NOT COMPLETED 430 451

    Baseline Characteristics

    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel Total
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks Total of all reporting groups
    Overall Participants 524 528 1052
    Age (years) [Mean (Standard Deviation) ]
    overall
    8.1
    (67.7)
    7.8
    (67.6)
    7.9
    (67.6)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    524
    100%
    528
    100%
    1052
    100%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival
    Description Median time (in months) from randomisation until death using the Kaplan-Meier method.
    Time Frame Patients were followed for survival up to 40 months

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    Measure Participants 524 528
    Median (Inter-Quartile Range) [Months]
    20.0
    19.2
    2. Secondary Outcome
    Title Progression Free Survival
    Description Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline
    Time Frame Patients were followed for progression up to 40 months

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    Measure Participants 524 528
    Median (Inter-Quartile Range) [Months]
    7.0
    7.9
    3. Secondary Outcome
    Title Incidence of Skeletal Related Events
    Description Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.
    Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    Measure Participants 524 528
    Median (Inter-Quartile Range) [Months]
    17.4
    17.3
    4. Secondary Outcome
    Title Time to Prostate-specific Antigen (PSA) Progression
    Description Median time (in months) from randomisation until first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.
    Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    Measure Participants 524 528
    Median (Inter-Quartile Range) [Months]
    11.9
    12.1
    5. Secondary Outcome
    Title Time to Pain Progression
    Description Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.
    Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    Measure Participants 524 528
    Median (Inter-Quartile Range) [Months]
    9.3
    10.0
    6. Secondary Outcome
    Title Pain Response
    Description Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.
    Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

    Outcome Measure Data

    Analysis Population Description
    The Pain Response Analysis Set includes patients who were either receiving opiates at baseline (randomisation) or with a baseline BPI score ≥2.
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    Measure Participants 362 373
    Number [Participants]
    255
    48.7%
    276
    52.3%
    7. Secondary Outcome
    Title Health Related Quality of Life
    Description Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.
    Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    Measure Participants 524 528
    Median (Inter-Quartile Range) [Months]
    4.4
    5.1
    8. Secondary Outcome
    Title PSA Response
    Description PSA response defined as >50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.
    Time Frame While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    Measure Participants 524 528
    Number [Participants]
    279
    53.2%
    298
    56.4%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title ZD4054 + Docetaxel Placebo + Docetaxel
    Arm/Group Description XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
    All Cause Mortality
    ZD4054 + Docetaxel Placebo + Docetaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    ZD4054 + Docetaxel Placebo + Docetaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 214/522 (41%) 203/525 (38.7%)
    Blood and lymphatic system disorders
    Febrile Neutropenia 22/522 (4.2%) 16/525 (3%)
    Anaemia 19/522 (3.6%) 8/525 (1.5%)
    Neutropenia 10/522 (1.9%) 12/525 (2.3%)
    Leukopenia 2/522 (0.4%) 4/525 (0.8%)
    Coagulopathy 0/522 (0%) 1/525 (0.2%)
    Lymphatic Obstruction 1/522 (0.2%) 0/525 (0%)
    Cardiac disorders
    Atrial Fibrillation 5/522 (1%) 2/525 (0.4%)
    Cardiac Failure 5/522 (1%) 2/525 (0.4%)
    Acute Myocardial Infarction 3/522 (0.6%) 4/525 (0.8%)
    Angina Pectoris 2/522 (0.4%) 2/525 (0.4%)
    Atrial Flutter 1/522 (0.2%) 2/525 (0.4%)
    Cardiac Failure Congestive 2/522 (0.4%) 0/525 (0%)
    Cardio-Respiratory Arrest 0/522 (0%) 2/525 (0.4%)
    Coronary Artery Stenosis 2/522 (0.4%) 0/525 (0%)
    Myocardial Infarction 2/522 (0.4%) 2/525 (0.4%)
    Myocardial Ischaemia 0/522 (0%) 2/525 (0.4%)
    Ventricular Tachycardia 0/522 (0%) 2/525 (0.4%)
    Angina Unstable 0/522 (0%) 1/525 (0.2%)
    Aortic Valve Disease 1/522 (0.2%) 0/525 (0%)
    Arrhythmia 0/522 (0%) 1/525 (0.2%)
    Bradycardia 1/522 (0.2%) 0/525 (0%)
    Cardiac Arrest 1/522 (0.2%) 1/525 (0.2%)
    Cardiopulmonary Failure 1/522 (0.2%) 0/525 (0%)
    Coronary Artery Disease 0/522 (0%) 1/525 (0.2%)
    Diastolic Dysfunction 0/522 (0%) 1/525 (0.2%)
    Hypertrophic Cardiomyopathy 1/522 (0.2%) 0/525 (0%)
    Left Ventricular Dysfunction 1/522 (0.2%) 0/525 (0%)
    Sinus Tachycardia 1/522 (0.2%) 0/525 (0%)
    Endocrine disorders
    Adrenal Insufficiency 1/522 (0.2%) 0/525 (0%)
    Adrenocortical Insufficiency Acute 0/522 (0%) 1/525 (0.2%)
    Inappropriate Antidiuretic Hormone Secretion 0/522 (0%) 1/525 (0.2%)
    Eye disorders
    Cataract 0/522 (0%) 1/525 (0.2%)
    Scleral Disorder 1/522 (0.2%) 0/525 (0%)
    Staphyloma 0/522 (0%) 1/525 (0.2%)
    Visual Acuity Reduced 1/522 (0.2%) 0/525 (0%)
    Gastrointestinal disorders
    Diarrhoea 6/522 (1.1%) 5/525 (1%)
    Constipation 3/522 (0.6%) 3/525 (0.6%)
    Ileus 0/522 (0%) 3/525 (0.6%)
    Abdominal Pain 2/522 (0.4%) 0/525 (0%)
    Enterocolitis 2/522 (0.4%) 0/525 (0%)
    Gastric Ulcer 1/522 (0.2%) 2/525 (0.4%)
    Haemorrhoids 1/522 (0.2%) 2/525 (0.4%)
    Nausea 2/522 (0.4%) 0/525 (0%)
    Upper Gastrointestinal Haemorrhage 2/522 (0.4%) 0/525 (0%)
    Vomiting 2/522 (0.4%) 1/525 (0.2%)
    Anal Fistula 0/522 (0%) 1/525 (0.2%)
    Ascites 0/522 (0%) 1/525 (0.2%)
    Colitis 0/522 (0%) 1/525 (0.2%)
    Colitis Ischaemic 1/522 (0.2%) 0/525 (0%)
    Colonic Polyp 1/522 (0.2%) 0/525 (0%)
    Diarrhoea Haemorrhagic 0/522 (0%) 1/525 (0.2%)
    Diverticulum 0/522 (0%) 1/525 (0.2%)
    Duodenal Ulcer 1/522 (0.2%) 1/525 (0.2%)
    Erosive Oesophagitis 1/522 (0.2%) 0/525 (0%)
    Gastric Ulcer Haemorrhage 1/522 (0.2%) 0/525 (0%)
    Gastritis 1/522 (0.2%) 1/525 (0.2%)
    Gastrointestinal Haemorrhage 0/522 (0%) 1/525 (0.2%)
    Haematemesis 1/522 (0.2%) 0/525 (0%)
    Inguinal Hernia 0/522 (0%) 1/525 (0.2%)
    Inguinal Hernia Strangulated 0/522 (0%) 1/525 (0.2%)
    Intestinal Infarction 1/522 (0.2%) 0/525 (0%)
    Irritable Bowel Syndrome 1/522 (0.2%) 0/525 (0%)
    Large Intestinal Haemorrhage 1/522 (0.2%) 0/525 (0%)
    Lower Gastrointestinal Haemorrhage 0/522 (0%) 1/525 (0.2%)
    Melaena 0/522 (0%) 1/525 (0.2%)
    Mouth Haemorrhage 1/522 (0.2%) 0/525 (0%)
    Neutropenic Colitis 0/522 (0%) 1/525 (0.2%)
    Oesophagitis Ulcerative 1/522 (0.2%) 0/525 (0%)
    Rectal Haemorrhage 1/522 (0.2%) 0/525 (0%)
    Rectourethral Fistula 1/522 (0.2%) 0/525 (0%)
    Small Intestinal Obstruction 1/522 (0.2%) 1/525 (0.2%)
    General disorders
    Pyrexia 6/522 (1.1%) 12/525 (2.3%)
    Death 10/522 (1.9%) 6/525 (1.1%)
    Oedema Peripheral 6/522 (1.1%) 3/525 (0.6%)
    General Physical Health Deterioration 0/522 (0%) 3/525 (0.6%)
    Asthenia 0/522 (0%) 2/525 (0.4%)
    Disease Progression 1/522 (0.2%) 2/525 (0.4%)
    Medical Device Complication 0/522 (0%) 2/525 (0.4%)
    Chest Pain 1/522 (0.2%) 0/525 (0%)
    Device Occlusion 1/522 (0.2%) 1/525 (0.2%)
    Pain 1/522 (0.2%) 0/525 (0%)
    Sudden Death 1/522 (0.2%) 0/525 (0%)
    Hepatobiliary disorders
    Cholecystitis Acute 0/522 (0%) 1/525 (0.2%)
    Hepatic Cirrhosis 0/522 (0%) 1/525 (0.2%)
    Hypertransaminasaemia 1/522 (0.2%) 0/525 (0%)
    Immune system disorders
    Drug Hypersensitivity 2/522 (0.4%) 0/525 (0%)
    Hypersensitivity 1/522 (0.2%) 1/525 (0.2%)
    Infections and infestations
    Pneumonia 26/522 (5%) 8/525 (1.5%)
    Sepsis 10/522 (1.9%) 2/525 (0.4%)
    Urinary Tract Infection 9/522 (1.7%) 7/525 (1.3%)
    Urosepsis 4/522 (0.8%) 5/525 (1%)
    Cellulitis 4/522 (0.8%) 1/525 (0.2%)
    Neutropenic Sepsis 4/522 (0.8%) 3/525 (0.6%)
    Bronchopneumonia 3/522 (0.6%) 2/525 (0.4%)
    Lung Infection 3/522 (0.6%) 0/525 (0%)
    Bronchitis 2/522 (0.4%) 1/525 (0.2%)
    Cystitis 2/522 (0.4%) 0/525 (0%)
    Gastroenteritis 2/522 (0.4%) 2/525 (0.4%)
    Infection 0/522 (0%) 2/525 (0.4%)
    Lobar Pneumonia 0/522 (0%) 2/525 (0.4%)
    Lower Respiratory Tract Infection 2/522 (0.4%) 2/525 (0.4%)
    Pharyngitis 2/522 (0.4%) 0/525 (0%)
    Pyelonephritis 2/522 (0.4%) 1/525 (0.2%)
    Sinusitis 2/522 (0.4%) 0/525 (0%)
    Skin Infection 2/522 (0.4%) 0/525 (0%)
    Upper Respiratory Tract Infection 2/522 (0.4%) 1/525 (0.2%)
    Abscess 0/522 (0%) 1/525 (0.2%)
    Abscess Limb 0/522 (0%) 1/525 (0.2%)
    Anal Abscess 0/522 (0%) 1/525 (0.2%)
    Appendicitis 1/522 (0.2%) 1/525 (0.2%)
    Arthritis Bacterial 0/522 (0%) 1/525 (0.2%)
    Arthritis Infective 0/522 (0%) 1/525 (0.2%)
    Bacterial Diarrhoea 1/522 (0.2%) 0/525 (0%)
    Catheter Site Infection 0/522 (0%) 1/525 (0.2%)
    Clostridium Difficile Colitis 0/522 (0%) 1/525 (0.2%)
    Diverticulitis 0/522 (0%) 1/525 (0.2%)
    Endocarditis 1/522 (0.2%) 0/525 (0%)
    Erysipelas 0/522 (0%) 1/525 (0.2%)
    Furuncle 0/522 (0%) 1/525 (0.2%)
    Herpes Zoster 1/522 (0.2%) 0/525 (0%)
    Labyrinthitis 1/522 (0.2%) 0/525 (0%)
    Localised Infection 0/522 (0%) 1/525 (0.2%)
    Lyme Disease 0/522 (0%) 1/525 (0.2%)
    Necrotising Fasciitis 1/522 (0.2%) 0/525 (0%)
    Neutropenic Infection 0/522 (0%) 1/525 (0.2%)
    Otitis Media 1/522 (0.2%) 0/525 (0%)
    Peritonitis Bacterial 1/522 (0.2%) 0/525 (0%)
    Pneumocystis Jiroveci Pneumonia 0/522 (0%) 1/525 (0.2%)
    Postoperative Wound Infection 0/522 (0%) 1/525 (0.2%)
    Psoas Abscess 0/522 (0%) 1/525 (0.2%)
    Pulmonary Tuberculosis 1/522 (0.2%) 0/525 (0%)
    Respiratory Tract Infection 1/522 (0.2%) 1/525 (0.2%)
    Staphylococcal Bacteraemia 1/522 (0.2%) 1/525 (0.2%)
    Staphylococcal Infection 1/522 (0.2%) 0/525 (0%)
    Subcutaneous Abscess 1/522 (0.2%) 0/525 (0%)
    Tooth Infection 0/522 (0%) 1/525 (0.2%)
    Tracheobronchitis 1/522 (0.2%) 0/525 (0%)
    Injury, poisoning and procedural complications
    Femoral Neck Fracture 2/522 (0.4%) 1/525 (0.2%)
    Subdural Haematoma 1/522 (0.2%) 2/525 (0.4%)
    Cerebral Haemorrhage Traumatic 0/522 (0%) 1/525 (0.2%)
    Facial Bones Fracture 1/522 (0.2%) 0/525 (0%)
    Hip Fracture 1/522 (0.2%) 1/525 (0.2%)
    Kidney Rupture 0/522 (0%) 1/525 (0.2%)
    Multiple Injuries 1/522 (0.2%) 0/525 (0%)
    Overdose 1/522 (0.2%) 0/525 (0%)
    Postoperative Wound Complication 0/522 (0%) 1/525 (0.2%)
    Radiation Pneumonitis 1/522 (0.2%) 0/525 (0%)
    Spinal Compression Fracture 0/522 (0%) 1/525 (0.2%)
    Stress Fracture 0/522 (0%) 1/525 (0.2%)
    Toxicity To Various Agents 1/522 (0.2%) 0/525 (0%)
    Wrist Fracture 1/522 (0.2%) 0/525 (0%)
    Haemoglobin Decreased 2/522 (0.4%) 0/525 (0%)
    Blood Electrolytes Abnormal 1/522 (0.2%) 0/525 (0%)
    Electrocardiogram QT Prolonged 0/522 (0%) 1/525 (0.2%)
    Neutrophil Count Decreased 0/522 (0%) 1/525 (0.2%)
    Transaminases Increased 0/522 (0%) 1/525 (0.2%)
    Metabolism and nutrition disorders
    Dehydration 7/522 (1.3%) 8/525 (1.5%)
    Hyponatraemia 6/522 (1.1%) 5/525 (1%)
    Hyperglycaemia 4/522 (0.8%) 3/525 (0.6%)
    Type 2 Diabetes Mellitus 0/522 (0%) 4/525 (0.8%)
    Hypophosphataemia 0/522 (0%) 2/525 (0.4%)
    Diabetes Mellitus 0/522 (0%) 1/525 (0.2%)
    Hyperkalaemia 0/522 (0%) 1/525 (0.2%)
    Hypernatraemia 1/522 (0.2%) 0/525 (0%)
    Hypocalcaemia 1/522 (0.2%) 1/525 (0.2%)
    Hypoglycaemia 1/522 (0.2%) 1/525 (0.2%)
    Musculoskeletal and connective tissue disorders
    Osteonecrosis Of Jaw 2/522 (0.4%) 2/525 (0.4%)
    Pathological Fracture 1/522 (0.2%) 2/525 (0.4%)
    Arthralgia 1/522 (0.2%) 0/525 (0%)
    Back Pain 1/522 (0.2%) 1/525 (0.2%)
    Bone Pain 0/522 (0%) 1/525 (0.2%)
    Bursitis 0/522 (0%) 1/525 (0.2%)
    Muscular Weakness 0/522 (0%) 1/525 (0.2%)
    Musculoskeletal Pain 1/522 (0.2%) 0/525 (0%)
    Myalgia 0/522 (0%) 1/525 (0.2%)
    Osteonecrosis 1/522 (0.2%) 1/525 (0.2%)
    Rheumatoid Arthritis 0/522 (0%) 1/525 (0.2%)
    Synovitis 0/522 (0%) 1/525 (0.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant Melanoma 0/522 (0%) 2/525 (0.4%)
    Basal Cell Carcinoma 1/522 (0.2%) 0/525 (0%)
    Bladder Transitional Cell Carcinoma 0/522 (0%) 1/525 (0.2%)
    Colorectal Cancer 0/522 (0%) 1/525 (0.2%)
    Gastrointestinal Stromal Tumour 0/522 (0%) 1/525 (0.2%)
    Lentigo Maligna Stage Unspecified 1/522 (0.2%) 0/525 (0%)
    Malignant Lymphoid Neoplasm 0/522 (0%) 1/525 (0.2%)
    Rectal Cancer 1/522 (0.2%) 0/525 (0%)
    Renal Cell Carcinoma 1/522 (0.2%) 0/525 (0%)
    Nervous system disorders
    Cerebrovascular Accident 3/522 (0.6%) 1/525 (0.2%)
    Cerebral Haemorrhage 0/522 (0%) 2/525 (0.4%)
    Cerebral Infarction 1/522 (0.2%) 2/525 (0.4%)
    Presyncope 1/522 (0.2%) 2/525 (0.4%)
    Transient Ischaemic Attack 0/522 (0%) 2/525 (0.4%)
    Convulsion 0/522 (0%) 1/525 (0.2%)
    Depressed Level Of Consciousness 1/522 (0.2%) 0/525 (0%)
    Diabetic Neuropathy 1/522 (0.2%) 0/525 (0%)
    Dizziness 1/522 (0.2%) 0/525 (0%)
    Encephalopathy 1/522 (0.2%) 0/525 (0%)
    Ischaemic Stroke 1/522 (0.2%) 1/525 (0.2%)
    Neurotoxicity 1/522 (0.2%) 0/525 (0%)
    Paraplegia 1/522 (0.2%) 0/525 (0%)
    Radiculopathy 1/522 (0.2%) 0/525 (0%)
    Spinal Cord Compression 1/522 (0.2%) 1/525 (0.2%)
    Subarachnoid Haemorrhage 1/522 (0.2%) 1/525 (0.2%)
    Syncope 1/522 (0.2%) 1/525 (0.2%)
    Psychiatric disorders
    Completed Suicide 1/522 (0.2%) 3/525 (0.6%)
    Confusional State 1/522 (0.2%) 0/525 (0%)
    Delirium 0/522 (0%) 1/525 (0.2%)
    Depression 0/522 (0%) 1/525 (0.2%)
    Renal and urinary disorders
    Renal Failure Acute 7/522 (1.3%) 2/525 (0.4%)
    Haematuria 2/522 (0.4%) 4/525 (0.8%)
    Urinary Retention 1/522 (0.2%) 2/525 (0.4%)
    Bladder Neck Obstruction 1/522 (0.2%) 0/525 (0%)
    Bladder Obstruction 1/522 (0.2%) 0/525 (0%)
    Calculus Ureteric 0/522 (0%) 1/525 (0.2%)
    Calculus Urinary 0/522 (0%) 1/525 (0.2%)
    Cystitis Noninfective 0/522 (0%) 1/525 (0.2%)
    Haemorrhage Urinary Tract 1/522 (0.2%) 0/525 (0%)
    Postrenal Failure 1/522 (0.2%) 0/525 (0%)
    Renal Colic 1/522 (0.2%) 0/525 (0%)
    Renal Failure 1/522 (0.2%) 0/525 (0%)
    Renal Tubular Necrosis 1/522 (0.2%) 0/525 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolism 6/522 (1.1%) 7/525 (1.3%)
    Dyspnoea 0/522 (0%) 5/525 (1%)
    Pleural Effusion 3/522 (0.6%) 4/525 (0.8%)
    Respiratory Failure 4/522 (0.8%) 2/525 (0.4%)
    Lung Disorder 2/522 (0.4%) 0/525 (0%)
    Respiratory Distress 2/522 (0.4%) 1/525 (0.2%)
    Acute Respiratory Distress Syndrome 1/522 (0.2%) 0/525 (0%)
    Acute Respiratory Failure 1/522 (0.2%) 0/525 (0%)
    Bronchitis Chronic 0/522 (0%) 1/525 (0.2%)
    Cough 1/522 (0.2%) 1/525 (0.2%)
    Emphysema 1/522 (0.2%) 0/525 (0%)
    Haemoptysis 0/522 (0%) 1/525 (0.2%)
    Interstitial Lung Disease 0/522 (0%) 1/525 (0.2%)
    Orthopnoea 0/522 (0%) 1/525 (0.2%)
    Pleural Haemorrhage 0/522 (0%) 1/525 (0.2%)
    Pneumonitis 1/522 (0.2%) 1/525 (0.2%)
    Skin and subcutaneous tissue disorders
    Erythema 0/522 (0%) 1/525 (0.2%)
    Skin Ulcer 1/522 (0.2%) 0/525 (0%)
    Stevens-Johnson Syndrome 0/522 (0%) 1/525 (0.2%)
    Vascular disorders
    Deep Vein Thrombosis 3/522 (0.6%) 2/525 (0.4%)
    Aortic Aneurysm 2/522 (0.4%) 0/525 (0%)
    Hypotension 2/522 (0.4%) 2/525 (0.4%)
    Jugular Vein Thrombosis 0/522 (0%) 2/525 (0.4%)
    Circulatory Collapse 0/522 (0%) 1/525 (0.2%)
    Femoral Artery Occlusion 0/522 (0%) 1/525 (0.2%)
    Haematoma 0/522 (0%) 1/525 (0.2%)
    Hypertension 1/522 (0.2%) 0/525 (0%)
    Hypovolaemic Shock 1/522 (0.2%) 1/525 (0.2%)
    Shock 1/522 (0.2%) 0/525 (0%)
    sThrombosis 0/522 (0%) 1/525 (0.2%)
    Other (Not Including Serious) Adverse Events
    ZD4054 + Docetaxel Placebo + Docetaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 490/522 (93.9%) 483/525 (92%)
    Blood and lymphatic system disorders
    Anaemia 155/522 (29.7%) 116/525 (22.1%)
    Neutropenia 114/522 (21.8%) 118/525 (22.5%)
    Leukopenia 64/522 (12.3%) 60/525 (11.4%)
    Eye disorders
    Lacrimation Increased 38/522 (7.3%) 36/525 (6.9%)
    Gastrointestinal disorders
    Diarrhoea 183/522 (35.1%) 185/525 (35.2%)
    Nausea 174/522 (33.3%) 160/525 (30.5%)
    Constipation 152/522 (29.1%) 129/525 (24.6%)
    Vomiting 110/522 (21.1%) 84/525 (16%)
    Dyspepsia 21/522 (4%) 40/525 (7.6%)
    Stomatitis 32/522 (6.1%) 35/525 (6.7%)
    Abdominal Pain 25/522 (4.8%) 34/525 (6.5%)
    Abdominal Pain Upper 31/522 (5.9%) 27/525 (5.1%)
    General disorders
    Oedema Peripheral 278/522 (53.3%) 188/525 (35.8%)
    Fatigue 150/522 (28.7%) 164/525 (31.2%)
    Asthenia 118/522 (22.6%) 117/525 (22.3%)
    Pyrexia 59/522 (11.3%) 60/525 (11.4%)
    Mucosal Inflammation 37/522 (7.1%) 28/525 (5.3%)
    Infections and infestations
    Rhinitis 51/522 (9.8%) 36/525 (6.9%)
    Urinary Tract Infection 37/522 (7.1%) 48/525 (9.1%)
    Nasopharyngitis 30/522 (5.7%) 36/525 (6.9%)
    Upper Respiratory Tract Infection 18/522 (3.4%) 27/525 (5.1%)
    Weight Decreased 37/522 (7.1%) 37/525 (7%)
    Metabolism and nutrition disorders
    Decreased Appetite 127/522 (24.3%) 119/525 (22.7%)
    Hypocalcaemia 29/522 (5.6%) 17/525 (3.2%)
    Hypokalaemia 25/522 (4.8%) 27/525 (5.1%)
    Musculoskeletal and connective tissue disorders
    Back Pain 94/522 (18%) 91/525 (17.3%)
    Arthralgia 80/522 (15.3%) 86/525 (16.4%)
    Pain In Extremity 71/522 (13.6%) 84/525 (16%)
    Myalgia 42/522 (8%) 53/525 (10.1%)
    Musculoskeletal Pain 46/522 (8.8%) 28/525 (5.3%)
    Muscle Spasms 22/522 (4.2%) 37/525 (7%)
    Muscular Weakness 29/522 (5.6%) 37/525 (7%)
    Bone Pain 28/522 (5.4%) 32/525 (6.1%)
    Musculoskeletal Chest Pain 32/522 (6.1%) 20/525 (3.8%)
    Nervous system disorders
    Headache 107/522 (20.5%) 71/525 (13.5%)
    Dysgeusia 88/522 (16.9%) 73/525 (13.9%)
    Neuropathy Peripheral 49/522 (9.4%) 65/525 (12.4%)
    Paraesthesia 45/522 (8.6%) 48/525 (9.1%)
    Dizziness 43/522 (8.2%) 45/525 (8.6%)
    Peripheral Sensory Neuropathy 41/522 (7.9%) 39/525 (7.4%)
    Hypoaesthesia 24/522 (4.6%) 28/525 (5.3%)
    Psychiatric disorders
    Insomnia 71/522 (13.6%) 59/525 (11.2%)
    Renal and urinary disorders
    Haematuria 30/522 (5.7%) 17/525 (3.2%)
    Dysuria 29/522 (5.6%) 19/525 (3.6%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 82/522 (15.7%) 72/525 (13.7%)
    Cough 58/522 (11.1%) 78/525 (14.9%)
    Nasal Congestion 78/522 (14.9%) 26/525 (5%)
    Dyspnoea Exertional 43/522 (8.2%) 38/525 (7.2%)
    Epistaxis 26/522 (5%) 31/525 (5.9%)
    Skin and subcutaneous tissue disorders
    Alopecia 178/522 (34.1%) 196/525 (37.3%)
    Rash 24/522 (4.6%) 40/525 (7.6%)
    Nail Discolouration 28/522 (5.4%) 39/525 (7.4%)
    Dry Skin 32/522 (6.1%) 28/525 (5.3%)
    Nail Disorder 23/522 (4.4%) 28/525 (5.3%)
    Vascular disorders
    Hypertension 16/522 (3.1%) 37/525 (7%)
    Hypotension 33/522 (6.3%) 28/525 (5.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    3. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. AstraZeneca can review results communications prior to public release and may within 60 days of receipt require amendments to be made. AstraZeneca can also require that submission or disclosure be delayed to allow for

    Results Point of Contact

    Name/Title Gerard Lynch
    Organization AstraZeneca
    Phone
    Email aztrial_results_posting@astrazeneca.com
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00617669
    Other Study ID Numbers:
    • D4320C00033
    First Posted:
    Feb 18, 2008
    Last Update Posted:
    Sep 10, 2012
    Last Verified:
    Apr 1, 2012