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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2007-005999-13
    Sponsor's Protocol Code Number:D8180C00034
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-005999-13
    A.3Full title of the trial
    A Phase II, Randomised, Open-label, Pilot Study to Evaluate the Safety and the Effects on Bone Resorption of AZD0530 in Patients with Prostate Cancer or Breast Cancer with Metastatic Bone Disease
    A.4.1Sponsor's protocol code numberD8180C00034
    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 nameAZD0530
    D.3.2Product code AZD0530
    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.3.9.1CAS number 379231-04-6
    D.3.9.2Current sponsor codeAZD0530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.IMP: 2
    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 nameAZD0530
    D.3.2Product code AZD0530
    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.3.9.1CAS number 379231-04-6
    D.3.9.2Current sponsor codeAZD0530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prostate Cancer or Breast Cancer with Metastatic Bone Disease
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the effect of AZD0530 plus standard of care (SoC) compared with
    zoledronic acid plus SoC on bone resorption by assessment of serum beta Cterminal
    cross-linking telopeptide of Type I collagen (βCTx)
    E.2.2Secondary objectives of the trial
    1. To investigate the safety and tolerability of AZD0530 in patients with either breast
    cancer or prostate cancer who have metastatic bone disease by assessment of
    Adverse Events (AEs), physical examination, blood pressure (BP), pulse, electrocardiogram (ECG), and laboratory findings
    2. To estimate the effect of AZD0530 plus SoC on bone turnover (bone resorption and bone formation) by assessment of serum markers bone-specific alkaline phosphatase (bALP), N-terminal propeptide of Type I collagen (PINP), cross-linked C-terminal telopeptide of Type I collagen (ICTP), and tartrate-resistant acid phosphatase 5b (TRAP5b) and urine markers N-terminal cross-linking telopeptide of Type I collagen normalised to creatinine (NTx/Cr) and alpha-alpha C-terminal cross-linking telopeptide of Type I collagen normalised to creatinine (ααCTx/Cr)
    3. To investigate the steady state pharmacokinetics (PK) of AZD0530 in this patient population by assessment of appropriate PK parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed, written informed consent
    2. Age 18 years and older
    3. Histologically or cytologically confirmed breast (female only) or prostate cancer
    4. At least one radiographically confirmed metastatic bone lesion
    5. No change of cancer therapy for at least 8 weeks before randomisation
    6. Urinary NTx/Cr greater than or equal to 30 nmol BCE/mmol creatinine
    7. World Health Organisation (WHO) performance status 0 to 2
    8. Life expectancy of more than 12 weeks
    9. Negative pregnancy test if female and of child-bearing potential

    For inclusion in this exploratory biomarker research, patients must:
    1. Provide informed consent for exploratory biomarker research

    For inclusion in this genetic research, patients must:
    1. Provide informed consent for genetic research
    E.4Principal exclusion criteria
    1. Brain metastases or risk of spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 1 week OR
    New neurological symptoms or signs consistent with acute or evolving spinal cord
    compression confirmed with magnetic resonance imaging (MRI) (stable,
    previously-treated patients are allowed) OR Other central nervous system metastatic involvement
    2. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count <1.5 x 10 to the power of 9/L or platelet count <100 x 10 to the power of 9/L
    3. Haemoglobin ≤ 9g/dL (5.59 mMol/L) (blood transfusion permitted following
    discussion with AstraZeneca Study Physician)
    4. Inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper
    limits of reference range (ULRR) or by alanine aminotransferase (ALT), aspartate
    aminotransferase (AST) or ALP ≥2.5 times the ULRR (≥5 times the ULRR in the
    presence of liver metastases). If bone metastases are present and liver function is otherwise considered adequate by the investigator then elevated ALP will not exclude the patient.
    5. Impaired renal function, defined by creatinine ≥1.5 times the ULRR or creatinine
    clearance of ≤ 50 mL/min determined by Cockcroft-Gault formula; or ≥ +2
    proteinuria on 2 consecutive dipsticks taken no less than 24 hours apart
    6. Any prior exposure to bisphosphonate therapy
    7. Have a planned change in cancer therapy before completion of the 4 week treatment period
    8. Have received in the previous 4 weeks any of the following:
    - cytotoxic chemotherapy
    - chemotherapy with novel, molecularly targeted agents
    9. Are receiving, or have received in the previous 12 months, any of the following:
    - PTH/ PTH analogue
    - Vitamin D analogues (eg, calcitriol)/ treatment with Vitamin D at doses of 1200 IU or greater for a period of three months or more
    10. Prior treatment with radiopharmaceuticals or radiotherapy to bone (focal
    radiotherapy of localised, non-target bone lesions would be permitted if completed
    up to 4 weeks prior to study entry)
    11. Have had hip fractures or bilateral hip prosthesis, fracture of any kind, or surgery to bone within 12 months of randomisation
    12. Evidence of severe or uncontrolled systemic conditions (eg, severe hepatic
    impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions
    which makes it undesirable for the patient to participate in the study or which could
    jeopardise compliance with the protocol
    13. Pregnant or breast-feeding women
    14. Unwillingness to use an acceptable method of contraception while on study (for
    women and men where female partner is of child bearing potential). (Postmenopausal status will be considered adequate evidence of non-childbearing
    potential and is defined as any 1 of the following: natural menopause with last
    menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago.
    Women with prior bilateral oophorectomy or hysterectomy will also be considered
    not of childbearing potential).
    15. Unresolved toxicity ≥ CTCAE grade 2 from previous anti-cancer therapy except
    alopecia
    16. Resting ECG with measurable QTc interval of >480 msec at 2 or more time points
    within a 24 hour period of each other
    17. Concomitant use of any medication or herbal supplement that may significantly
    modulate CYP3A4 activity or the activity of which is significantly modified by
    CYP3A4 (with special regard to those calcium channel antagonists that are
    CYP3A4 substrates). Such drugs must have been discontinued for approximately 2
    weeks or more prior to starting the study medication except for pimozide,
    astemizole and amiodarone where the time interval to study entry will be 4, 8 and
    12 weeks, respectively. See Appendix E for a list of warnings of possible drug
    interactions.
    18. History of ischaemic heart disease with myocardial infarction within 3 months of
    study entry, symptomatic cardiac ischaemia or symptomatic congestive heart failure
    19. Any other concurrent condition which in the investigator’s opinion makes it
    undesirable for the patient to participate in the trial or which would jeopardise
    compliance with the protocol
    20. Patients believed to have a known immunodeficiency syndrome
    21. Participation in another study with an investigational product within the previous 30 days or participation in a previous clinical study within 30 days prior to study entry
    22. Risk (in the investigator’s opinion) of transmitting, through blood or other body
    fluids, the agents responsible for Acquired Immunodeficiency Syndrome, hepatitis
    B, or hepatitis C
    E.5 End points
    E.5.1Primary end point(s)
    The absolute and percentage change from baseline in serum βCTX
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 No
    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
    End of the study is defined as the time point after which no patient will be exposed to study related activities, including the 30 days follow up following study treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 122
    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 Decision2008-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-20
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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