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    Summary
    EudraCT Number:2007-003224-38
    Sponsor's Protocol Code Number:D4320C00015
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLatvia - SAM
    A.2EudraCT number2007-003224-38
    A.3Full title of the trial
    A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients
    A.4.1Sponsor's protocol code numberD4320C00015
    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 AB
    B.1.3.4CountrySweden
    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.4.2Country
    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.3.1Product nameZibotentan
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typeEndothelin (ETa) receptor antagonist
    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
    Hormone-refractory prostate cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To determine the effect of ZD4054 on overall survival compared to placebo
    2. To assess the effect of ZD4054 on progression free survival compared to placebo
    E.2.2Secondary objectives of the trial
    1. To investigate the tolerability and safety profile of ZD4054
    2. To investigate the effect of ZD4054 on time to prostate-specific antigen (PSA) progression compared to placebo
    3. To assess the effects of ZD4054 on Health-related Quality of Life (HRQOL) compared to placebo
    4. To investigate the effect of ZD4054 on time to symptomatic progression compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study patients must fulfil all of the following criteria:
    1.Provision of informed consent
    2.Male, aged 18 years or older
    3.Histological or cytological confirmation of adenocarcinoma of the prostate
    4.No evidence of metastatic disease on:
    -CT scan of chest (CT scan only to be performed if clinically indicated i.e. if lung metastases are suspected)
    -CT scan or MRI scan of the abdomen/pelvis
    -Bone scan (In the event that bone scans cannot be performed due to a Technetium 99 (Tc-99) radioisotope shortage, please see section 4.6.6.1 of protocol)
    Patients with prostate cancer involving the pelvic lymph nodes are acceptable providing that:
    -In the opinion of the investigator the patient is not a candidate for local/salvage therapy
    -Only a single lymph node is enlarged in which case there is no size limit OR if there are multiple enlarged lymph nodes then they must be ≤2cm in size (based on short axis measurement).
    -There is no lymph node disease above the aortic bifurcation
    Patients with evidence of local disease progression or recurrence that the Investigator would normally treat with local therapy are excluded. A patient can be enrolled as long as any residual prostatic disease in the pelvis that was present at the initiation of castration therapy has not changed significantly and would not normally be treated by local therapy by the Investigator.
    5.Biochemical progression of prostate cancer, defined as at least 2 stepwise increases in a series of any 3 PSA values collected while the patient is castrate. The 3 PSA values selected do not need to be consecutive, and do not need to include the most recent PSA collected at or prior to study enrolment but must meet the following criteria:
    -There must be at least 14 days between each of the 3 PSA values, and each must be collected no more than 1 year before enrolment into the study
    -The last PSA value in the series of 3 must be either an increase of ≥25% of the first PSA or an absolute increase of ≥10 ng/mL over the first PSA
    -The last PSA value in the series of 3 must be ≥1.2 ng/mL in patients who have had a radical prostatectomy and ≥5 ng/mL in all other patients
    -Each of the 3 PSA values must be collected whilst the patient is under medical castration or is surgically castrated
    6.Continuously medically castrated with stable treatment for at least 8 weeks prior to study randomisation or surgically castrated. Acceptable medical castration includes luteinising hormone-releasing hormone analogues (LHRHa), estradiol, estramustine or other estrogen based preparations. Anti-androgens can be taken in conjunction with medical castration. Serum testosterone must be ≤2.4nmol/L (70ng/dL) at enrolment despite method of castration.
    7.World Health Organisation (WHO) performance status 0 – 1
    8.Life expectancy of 6 months or more.
    For inclusion in the genetic research, patients must fulfil the following criterion:
    1.Provision of informed consent for genetic research.
    If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to participate.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1.Current use (from the time that written informed consent is given) of any opiates, with the exception of opiates taken PRN for non-disease-related symptoms
    2.Definitive therapy to treat the patient’s primary prostate cancer (prostatectomy, radiotherapy, cryotherapy) within 3 months prior to study entry
    3.Prior cytotoxic chemotherapy (such as paclitaxel, docetaxel and mitoxantrone) for the treatment of recurrent prostate cancer (prior estramustine therapy is allowed). Prior targeted cancer therapies, such as EGF, EGFR, VEGF and VEGFR, or immune cell therapy, are only permitted if the patient received them during participation in a previous clinical trial.
    4.Use of intravenous bisphosphonates within 6 weeks prior to start of study treatment. Oral bisphosphonates for prevention and/or treatment of osteoporosis are permitted. Oral bisphosphonate dose must be stable for a minimum of 4 weeks prior to starting study treatment. Intravenous bisphosphonates are permitted after disease progression, however dose must be stable within trial
    5.Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine and phenobarbitone, St John’s Wort) within 2 weeks prior to start of 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 prior to starting study treatment
    7.Have received investigational drug in another clinical study of anticancer therapy, within 4 weeks prior to starting study treatment
    8.Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists
    9.History of past or current epilepsy, epilepsy syndrome, or other seizure disorder
    10.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
    11.QT interval corrected for heart rate (eg, by Bazett’s correction) >470 msec
    12.Previous history or presence of another malignancy, other than prostate cancer, treated squamous/basal cell carcinoma of the skin, or melanoma that has been fully excised with no signs of residual disease or recurrence at the time of study enrolment, within the last 5 years.
    13.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
    14.Haemoglobin (Hb) <9 g/dL. Concomitant use of erythropoietin or blood transfusions is allowed
    15.Serum bilirubin greater than 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 hemolysis or hepatic pathology), who will be allowed in consultation with their physician
    16.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the ULN
    17.Creatinine clearance of <50 mL/minute, determined using the Cockcroft-Gault equation or by 24-hour creatinine clearance
    18.Patients who have been previously randomised in this study cannot be re-randomised. Patients who fail to meet the inclusion/exclusion criteria may be reconsidered once for participation in the study.
    19.Involvement in the planning and conduct of the study (ICON and AstraZeneca staff or staff at the study site).
    The following are regarded as exclusion criteria for genetic research:
    1.The patient has undergone a previous bone marrow transplant
    2.The patient has undergone a whole blood transfusion in the preceding 90 days.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival, defined as time to death (from randomisation) from any cause
    Progression free survival defined as the time from randomisation until documentation of progressive metastatic disease.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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.7.1.3.1Other 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 No
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA104
    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 Yes
    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 years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 784
    F.4.2.2In the whole clinical trial 1507
    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 Decision2008-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
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