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    Summary
    EudraCT Number:2004-000344-24
    Sponsor's Protocol Code Number:D4320C00006
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-000344-24
    A.3Full title of the trial
    A phase II, randomised, double-blind, parallel-group, placebo-controlled, multi-centre study to assess the efficacy and safety of once-daily orally administered ZD4054 15 mg and 10 mg doses in pain-free or mildly symptomatic patients with prostate cancer and bone metastases, who have rising serum prostate specific antigen (PSA) levels despite medical or surgical castration
    A.3.2Name or abbreviated title of the trial where available
    EPOC
    A.4.1Sponsor's protocol code numberD4320C00006
    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 Information not present in EudraCT
    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 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 and 15
    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 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 Information not present in EudraCT
    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 placeboTablet
    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 6.1
    E.1.2Level LLT
    E.1.2Classification code 10062904
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the effect of ZD4054 on time to progression in metastatic hormone refractory prostate cancer, which will recommend a dose of ZD4054 for use in future studies.
    E.2.2Secondary objectives of the trial
    1. To investigate the effect of ZD4054 on the time to death.
    2. To investigate the effect of ZD4054 on PSA.
    3. To investigate the tolerability and safety profile of ZD4054 at the studied doses.
    4. To investigate the effect of ZD4054 on objective response rate.
    5. To investigate the pharmacokinetic characteristics of ZD4054.
    6. To investigate the rate of development of new bone lesions.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of written informed consent to participate in the study
    2. Male, aged 18 years or older
    3. Surgically castrated or continuously medically castrated with luteinising hormone-releasing hormone (LHRH) analogue
    4. Patients with a serum testosterone inferior or equal to 1.73 nmol/L (50 ng/dL)
    5. Histological or cytological confirmation of adenocarcinoma of the prostate.
    6. Documented evidence of bone metastases, as assessed by bone scintigraphy performed according to the standard bone acquisition protocol developed specifically for this study.
    - Patients must have disease involvement of less than 75% of the spine, 75% of the pelvis or 75% of the ribs in the anteroposterior (AP) or posteroanterior (PA) view.
    - Patients with inferior or equal to 3 hot spots on the bone scan will require an additional scan to confirm metastatic disease, such as CT, magnetic resonance imaging (MRI) or X-ray, to be determined by the investigator.
    7. Biochemical progression of prostate cancer, documented while the patient is castrate, by a rise in PSA that meets any one or more of the following criteria:
    Biochemical progression criterion 1:
    A second PSA value higher than a first PSA (reference) value. To be followed by a third PSA value higher than the second value.
    - 2 weeks minimum time interval between sampling
    - All samples must have been taken within a 6-month period of randomisation to the study
    - All PSA values must be superior or equal to 5 ng/mL
    Biochemical progression criterion 2:
    A second PSA value higher than a first PSA (reference) value. Followed by a third PSA value lower than the second, but with a fourth PSA value higher than the second.
    - 2 weeks minimum time interval between sampling
    - All samples must have been taken within a 6-month period of randomisation to the study
    - All PSA values must be superior or equal to 5 ng/mL
    Biochemical progression criterion 3:
    A PSA value greater than or equal to a doubling of a first PSA (reference) value. This must be confirmed by an additional PSA assessment which is also greater than or equal to a doubling of the reference value.
    - 2 weeks minimum time interval between sampling
    - All samples must have been taken within a 6-month period of randomisation to the study
    - All PSA values must be superior or equal to 5 ng/mL
    Historical values may be used if they have been obtained from the same laboratory using the same PSA assay.
    8. Creatinine clearance of >60 mL/minute, determined using the Cockcroft-Gault equation or by 24-hour creatinine clearance.
    9. World Health Organisation (WHO) performance status 0 – 1 .
    10. Life expectancy of 6 months or more
    11. Clearly understand and be likely to comply with all study procedures
    E.4Principal exclusion criteria
    1. Current use (from the time that written informed consent is given) of any opiates listed in Appendix E of the protocol.
    2. Prior radiotherapy to bone metastases within 4 weeks of randomisation to the study.
    3. Prior cytotoxic chemotherapy for the treatment of their recurrent prostate cancer, such as estramustine, paclitaxel, docetaxel and mitoxantrone.
    4. Corticosteroids, including hydrocortisone, for the treatment of their recurrent prostate cancer within 4 weeks of randomisation to the study. Please note that if taking corticosteroids for another reason, the treatment must be at a dose that is stable for a minimum of 12 weeks prior to randomisation to the study.
    5. Antiandrogens, within 4 weeks of randomisation to the study for flutamide or within 6 weeks of randomisation to the study for bicalutamide and nilutamide. Continued elevation of their PSA, according to inclusion criterion number 7 (see Section 3.3.2 in the protocol), can be demonstrated during the washout times provided above.
    6. Treatment with strontium-89, rhenium-186-HEDP and samarium-153-EDTMP for bone metastases, within 12 weeks of randomisation to the study.
    7. Neurologic symptoms or signs consistent with acute or evolving spinal cord compression, confirmed with MRI. Stable, previously treated patients are allowed.
    8. Stage II, III or IV cardiac failure, classified according to New York Heart Association (NYHA) classification.
    9. QT interval corrected for heart rate (QTc) >470 msec.
    10. 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.
    11. Epilepsy or other seizure disorder, unless agreed upon by AstraZeneca.
    12. Central nervous system metastases.
    13. Total serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).
    14. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the ULRR.
    15. Haemoglobin inferior or equal to 9 g/dL, neutrophils <1.5 x 109/L or platelets <75 x 109/L.
    16. Prior therapy with endothelin receptor antagonists
    17. Current therapy, or therapy within 2 weeks of randomisation to the study, with indinavir, itraconazole, ketoconazole and ritonavir (highly potent inhibitors of CYP450 3A4).
    18. Current therapy, or therapy within 2 weeks of randomisation to the study, with carbamazepine, phenobarbitone, phenytoin, rifampicin and St John’s Wort (highly potent CYP450 inducers).
    19. Use of systemic retinoids and herbal medicines or remedies (specifically, but not exclusively, to include saw palmetto and PC SPES), within 2 weeks of randomisation to the study.
    20. Any serious condition which, in the opinion of the investigator, would present a risk to the patient participating in this study.
    21. Have received investigational drug in another clinical study of anti-cancer therapy, within 4 weeks prior to consenting to this study. Please note restriction number 1 on bisphosphonates (see Section 3.3.4 in the protocol).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is defined as time to progression (TTP). The endpoint is in fact a composite of objective and clinical measures of disease progression. This reflects the difficulty encountered in clinical practice of determining objective progression of prostate cancer metastatic to bone. However it is anticipated that the endpoint will provide data on the impact of study drug on disease progression as reflected by routine clinical management of the 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.2.3.1Comparator description
    Best supportive care
    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
    The end date given is that estimated for time to a minimum of 200 patient deaths, and therefore dependent upon the rate of deaths within the study. Specific details in the protocol).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 260
    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 Decision2004-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-02-06
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