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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41472   clinical trials with a EudraCT protocol, of which   6816   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2015-004433-26
    Sponsor's Protocol Code Number:3638
    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:2016-03-17
    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 number2015-004433-26
    A.3Full title of the trial
    Zoledronic acid in the management of malignant pleural mesothelioma - a feasibility study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Zoledronic acid in the management of Mesothelioma - a feasibility trial
    A.3.2Name or abbreviated title of the trial where available
    ZOL-A trial
    A.4.1Sponsor's protocol code number3638
    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 supportNIHR - RfPB funding
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorth Bristol NHS Trust
    B.5.2Functional name of contact pointDuneesha de Fonseka
    B.5.3 Address:
    B.5.3.1Street AddressLearning and Reasearch Building, Level 2, Southmead Hospital
    B.5.3.2Town/ cityBristol
    B.5.3.3Post codeBS10 5NB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01174148041
    B.5.6E-mailduneesha.defonseka@nbt.nhs.uk
    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 4 mg/5 ml 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 nameZoledronic acid
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZoledronic acid
    D.3.9.1CAS number 118072-93-8
    D.3.9.3Other descriptive nameZoledronic acid monohydrate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4mg to in 5ml
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboInfusion
    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 mesothelioma
    E.1.1.1Medical condition in easily understood language
    Cancer of the lung lining, usually as a consequence of previous asbestos exposure.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10027406
    E.1.2Term Mesothelioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10035603
    E.1.2Term Pleural mesothelioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10059518
    E.1.2Term Pleural mesothelioma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    As this is a feasibility study there are no primary or secondary objectives to the trial. The overarching question is whether it would be feasible to run a full trial to determine if the addition of Zoledronic acid to 1st line chemotherapy would confer a further benefit to patients with mesothelioma, with regards to survival.
    The feasibility of this trial will be assessed along the following criteria:
    1. Feasibility of randomising 50 patients in 12 months
    2. Acceptability of recruitment procedures, consent and randomisation, and data collection methods.
    3. Acceptability of ZA in MPM patients, and the optimal timing and location for ZA administration.
    4. Qualitative assessment in a subgroup of 10 patients (from the randomised and non-randomised groups) to evaluate patients' experience in the randomisation and/or recruitment process
    5. Quantification of drop-out and data completeness rates
    6. Estimates of outcome event rates eg. survival times, measures of mean response and outco
    E.2.2Secondary objectives of the trial
    If this trial proves that it is feasible to run an appropriately statistically powered trial, the outcomes we would be looking for are as below:

    • Proportion of patients with progression free survival at 6 months
    • Time to progression
    • Overall survival from randomisation
    • Progression free survival from randomisation
    • Rate of progression of MPM, as measured by modified RECIST criteria on CT, after 3 cycles of chemotherapy (Pemetrexed/Cisplatin)
    • Rate of progression in MPM, as measured by modified RECIST criteria on CT, after 6 cycles of chemotherapy.
    • Tumour metabolic activity as determined by Total glycolytic volume (TGV) on PET-CT scans, after 3 cycles of chemotherapy
    • Value of TGV or standard uptake value (SUV) in the assessment of disease response/progression
    • Serum mesothelin as a useful biomarker for monitoring disease and detecting treatment response
    • Quality of life determined by dyspnoea Visual analogue scale (VAS) scores and EQ5D
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histo-cytologically confirmed diagnosis of MPM
    -WHO performance status 0-1
    -Eligible for first line chemotherapy treatment
    -Measurable disease on CT as per modified RECIST criteria (tumour thickness >5mm)
    -Ability to give informed consent
    E.4Principal exclusion criteria
    Not fit for chemotherapy due to performance status or other comorbidities
    Previous chemotherapy for MPM
    IV bisphosphonates in the 3 months preceding randomisation
    Significant renal disease (eGFR < 30ml/min in the last 4 weeks)
    Hypocalcaemia (current hypocalcaemia on treatment, evidence of hypocalcaemia on most recent blood tests – should be within the last 6 weeks)
    Known allergy to bisphosphonates or excipients of its preparation
    Severe untreated dental caries
    Concomitant participation in another drug trial for mesothelioma
    Allergy to 18-Fluodeoxyglucose used for the PET scan
    Women of child bearing potential (defined as fertile, or following menarche and until becoming post-menopausal unless permanently sterile)
    E.5 End points
    E.5.1Primary end point(s)
    As this is a feasibility trial,the feasibility assessments will be along the points below:

    1. Feasibility of randomising 50 patients over a 12 month period
    2. Acceptability of recruitment procedures, consent and randomisation, and data collection methods.
    3. Acceptability of ZA in MPM patients, and the optimal timing and location for ZA administration.
    4. Qualitative assessment in a subgroup of 10 patients to evaluate patients' experience in the randomisation and recruitment process
    5. Quantification of drop-out and data completeness rates
    6. Estimates of outcome event rates eg. survival times, measures of mean response and outcome variance (continuous variables such as quality of life) and confidence intervals around estimates of proportions, categorical variables such as recruitment rates)to use for calculating full trial size and number of sites.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Following completion of 6 months of follow-up for all recruited patients
    E.5.2Secondary end point(s)
    -Acceptability of recruitment procedures, consent and randomisation, and data collection methods.
    -Acceptability of ZA in MPM patients, and the optimal timing and location for ZA administration.
    -Qualitative assessment in a subgroup of 10 patients to evaluate patients experience in the randomisation and recruitment process
    -Quantification of drop-out and data completeness rates
    -Estimates of outcome event rates eg. survival times, measures of mean response and outcome variance (continuous variables such as quality of life) and confidence intervals around estimates of proportions, categorical variables such as recruitment rates)to use for calculation of full trial size and number of recruitment centres
    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 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open label third arm for those not having concurrent chemotherapy
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state70
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 70
    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)
    The intervention will cease prior to end of trial as ZA/placebo is only given alongside first line chemotherapy which is only 6 cycles.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-24
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