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    The EU Clinical Trials Register currently displays   39833   clinical trials with a EudraCT protocol, of which   6536   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2007-003227-20
    Sponsor's Protocol Code Number:D4320C00014
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-12-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-003227-20
    A.3Full title of the trial
    A Phase III, Randomised, Double-blind Study to Assess the Efficacy and
    Safety of 10 mg ZD4054 versus Placebo in Patients with Hormone-resistant
    Prostate Cancer and Bone Metastasis who are Pain Free or Mildly
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD4320C00014
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASTRAZENECA
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code ZD4054
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeZD4054
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Hormone-resistant
    Prostate Cancer and Bone Metastasis who are Pain Free or Mildly
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036911
    E.1.2Term Prostate cancer recurrent
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect
    of ZD4054 on overall
    survival, defined as time
    to death (from
    randomisation) from
    any cause, compared to
    E.2.2Secondary objectives of the trial
    1. To assess the effect
    of ZD4054 on progression free
    survival, defined as time from randomisation into the study until clinical progression of disease,
    compared to placebo
    2. To investigate the tolerability and safety profile of ZD4054
    compared to placebo
    3. To assess the effect of ZD4054 on time to use of opiates compared
    to placebo
    4. To assess the effect of ZD4054 on the
    incidence of skeletal related events compared to placebo
    5. To investigate the effects of ZD4054 on bone metastases formation compared to
    6. To assess the effects of ZD4054 on Health Related Quality of Life
    (HRQOL) compared to placebo
    7. To investigate the effect of ZD4054 on time to prostate-specific
    antigen (PSA) progression compared
    to placebo
    8. To assess the effects of ZD4054 on time to pain progression compared to placebo
    9. To investigate the effects of ZD4054 on time to initiation of chemotherapy compared to placebo
    1o. ......
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of informed consent
    2. Male, aged 18 years or older
    3. Histological or cytological confirmation of adenocarcinoma of the prostate
    4. Documented evidence of bone metastasis on radionuclide bone scan. Patients must
    have disease involvement <75% of the spine, pelvis and ribs in the anteroposterior
    (AP) or posteroanterior (PA) view. Patients with &#8804;3 lesions seen on bone scan will
    require a CT scan, MRI or x-ray to confirm
    5. Biochemical progression of prostate cancer, documented while the patient is
    &#8722; Biochemical progression is defined as at least 2 stepwise increases in PSA over
    a period of &#8805;1 month (values do not need to be consecutive but 2 values that
    have increased since the previous highest value are required) with at least
    14 days between each measurement irrespective of assay or laboratory
    &#8722; Historical values may be used
    &#8722; The last PSA must be an increase of &#8805;50 % of the first PSA value of the
    3 values or an absolute increase of &#8805;10 ng/mL over the initial PSA
    &#8722; The final PSA value must be &#8805;1.2 ng/mL in patients who have had a radical
    prostatectomy and &#8805;5 ng/mL in all other patients
    6. Asymptomatic or mild pain from prostate cancer, defined as a score of &#8804;2 in the
    worst pain item of the BPI
    7. Surgically castrated or continuously medically castrated with serum testosterone
    &#8804;2.4 nmol/L (70 ng/dL)
    8. World Health Organisation (WHO) performance status 0 - 1
    9. Life expectancy of 6 months or more.
    E.4Principal exclusion criteria
    1. Radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study
    2. Current use (from the time that written informed consent is given) of any opiates,
    with the exception of opiates taken PRN for pain not directly related to prostate
    3. Prior cytotoxic chemotherapy (such as paclitaxel, docetaxel and mitoxantrone) for
    the treatment of recurrent prostate cancer (prior estramustine therapy is allowed), as
    well as other targeted cancer therapies (such as EGF, EGFR, VEGF and VEGFR)
    4. Systemic radionuclide therapy (ie, strontium chloride Sr89, 186Relabeled HEDP, or
    153Sm-EDTMP pentasodium) within 12 weeks of starting study treatment
    5. Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine,
    phenobarbitone and St John’s Wort) within 2 weeks of starting study treatment.
    Dexamethasone will be allowed if the investigator feels it is necessary but is
    encouraged to use a different form of steroid treatment wherever possible
    6. Use of systemic retinoids within 2 weeks of starting study treatment
    7. Have received investigational drug in another clinical study of anticancer therapy,
    within 4 weeks of starting study treatment
    8. Prior therapy with endothelin receptor antagonists or family history of
    hypersensitivity to endothelin antagonists
    9. Neurological symptoms or signs consistent with acute or evolving spinal cord
    compression. If a patient has neurologic symptoms, an MRI must be performed that demonstrates no impending or actual spinal cord compression. Stable, previously
    treated patients are allowed
    10. Symptomatic peripheral neuropathy of CTCAE grade 2 or higher
    11. Known or suspected central nervous system metastases
    12. History of past or current epilepsy, epilepsy syndrome, or other seizure disorder
    13. Stage II, III or IV cardiac failure (classified according to New York Heart
    Association (NYHA) classification) or myocardial infarction within 6 months prior
    to study entry
    14. QT interval corrected for heart rate eg, by Bazett’s correction >470 msec
    15. Previous history or presence of another malignancy, other than prostate cancer or
    treated squamous/basal cell carcinoma of the skin, within the last 5 years
    16. In the opinion of the investigator, any evidence of severe or uncontrolled systemic
    disease (eg, currently unstable or uncompensated respiratory, cardiac, hepatic or
    renal disease) or evidence of any other significant clinical disorder or laboratory
    finding that makes it undesirable for the patient to participate in the study
    17. Hemoglobin (Hb) <9 g/dL. Concomitant use of erythropoietin or blood
    transfusions is allowed
    18. Serum bilirubin >1.5 times the upper limit of normal (ULN). This will not apply to
    patients with Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is
    predominantly unconjugated in the absence of evidence of haemolysis or hepatic
    pathology), who will be allowed in consultation with their physician
    19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times
    the ULN or 5 times the ULN in the presence of liver metastasis
    20. Creatinine clearance of <50 mL/minute, determined using the Cockcroft-Gault
    equation or by 24-hour creatinine clearance
    21. ......
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival defined as:
    Time to death (from randomisation) from any cause
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 295
    F.4.2.2In the whole clinical trial 580
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-06-30
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