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    Summary
    EudraCT Number:2009-009134-32
    Sponsor's Protocol Code Number:2137/09
    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:2009-04-16
    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 number2009-009134-32
    A.3Full title of the trial
    Bristol Randomised Controlled Trial of Zoledronic Acid in Malignant Pleural disease(Pilot Study).
    A.4.1Sponsor's protocol code number2137/09
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN17030426
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNorth Bristol NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Zometa 4mg/5ml Concentrate for Solution for Infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameZometa 4mg/5ml concentration for solution for infusion
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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 typeAminobisphosphonate with anti-tumour activity
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Malignant pleural disease of all histological cell types. 50% patients in trial will have indwelling pleural catheters for management of breathlessness.
    E.1.1.1Medical condition in easily understood language
    Patients with cancer of the lining of the lung. Half of patients will have a long term tube in place, which drains fluid from around the lung to improve their breathlessness.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 examine whether zoledronic acid in the form of Zometa reduces pleural fluid production, tumour volume and improves breathlessness and quality of life in patients with a malignant pleural disease when administered in its licenced dose for administration to patients with malignancy.
    E.2.2Secondary objectives of the trial
    To establish drug concentration in pleural fluid following intravenous administration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1/. Malignant pleural thickening with or without pleural effusion with a. malignant fluid cytology or b. malignant pleural biopsy histology or c. in the context of clinically proven cancer elsewhere with no alternative cause found for the pleural thickening or effusion
    and
    2/. Age > 18 years

    E.4Principal exclusion criteria
    1/. Chemical or surgical pleurodesis in the preceding 30 days.
    2/. IV bisphosphonate within the past 3 months or ongoing therapy.
    3/. Ongoing dental disease requiring intervention.
    4/. Significant renal failure (calculated creatinine clearance of <40ml/min)
    5/. Hypocalcaemia at randomisation.
    6/. Inability to give informed consent.
    7/. Pregnancy or lactation.
    8/. Known allergy to bisphosphonates or exipients in the intervention preparation.
    9/. Life expectancy < 4 months.
    10/. Current or planned chemotherapy (However patients receiving the oral chemotherapy agent, tarceva who have been on it for more than 3 months can be included).
    11/. Hormone manipulation therapy initiated in the month before trial entry (however patients receiving long term hormone manipulation can be included).
    12/. Haematological malignancy.
    13/. Age < 18 years (no upper age limit).
    14/. Severe visual impairment.
    E.5 End points
    E.5.1Primary end point(s)
    1/. Change in gadolinium uptake and washout rate on DCE-MRI
    2/. Change in dyspnoea VAS score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over the 9 week trial period, with long term follow up in the specialist pleural clinic at Southmead Hospital
    E.5.2Secondary end point(s)
    1/. Disease progression as measured by volume of pleural thickening on CT scan
    2/. Disease progression as measured by volume of pleural thickening on DCE-MRI scan.
    3/. For patients with a pleurx catheter in situ, change in fluid volume production between week 2 of run in period and each week post intervention or placebo.
    4/. For patients with pleurx catheter in situ, spontaneous pleurodesis rate.
    5/. Change in pleural fluid and plasma VEGF-A between baseline and each aspiration following intervention or placebo (with correlation to fluid drainage in pleurx patients).
    6/. Change in volume of pleural fluid on CT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over the 9 week trial period, with long term follow up in the specialist pleural clinic at Southmead Hospital
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    This pilot study will be complete when the last patient attends their last visit 21 days following administration of the final dose of zometa
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal clinical follow up in a specialist pleural clinic at Southmead Hospital.
    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 Decision2009-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-02
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