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    Summary
    EudraCT Number:2006-004592-35
    Sponsor's Protocol Code Number:6836
    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:2010-06-17
    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 number2006-004592-35
    A.3Full title of the trial
    A Randomised Stratified Multicentre Phase II Clinical Trial of Single-Agent ADI-PEG 20 (Pegylated Arginine Deiminase) in Patients with Malignant Pleural Mesothelioma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study looking at a new drug to treat mesothelioma (ADAM)
    A.3.2Name or abbreviated title of the trial where available
    ADAM (Arginine Deiminase And Mesothelioma)
    A.4.1Sponsor's protocol code number6836
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01279967
    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 SponsorBarts Health 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 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 namePegylated Arginine Deiminase
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mesothelioma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the time to disease progression between the control group receiving best supportive care and the group receiving ADI-PEG 20 and best supportive care.
    E.2.2Secondary objectives of the trial
    The following will be assessed in control and ADI-PEG-20 groups:

    i)To measure the response rate (partial response (PR) and complete response (CR)

    ii)To measure the median overall survival rates (or at 18 month survival)

    iii)To assess the safety (adverse events)

    Tertiary and Exploratory Objectives

    Tertiary
    i)To measure peripheral blood arginine and citrulline levels, levels of ADI-PEG 20 and development of antibodies to ADI-PEG 20

    ii)To measure serum mesothelin as a tumour marker for the management of patients with MPM

    Exploratory Objectives
    i)Pharmacogenomics
    Construction of a cDNA library to enable microarray analysis to establish
    clinically relevant biomarkers. Tumour and peripheral blood leukocyte genomic DNA will be obtained and banked to enable prospective pharmacogenomic studies. These may include analysis of gene copy number by microarray-based comparative genomic hybridization (CGH) analysis and single nucleotide polymorphism (SNP) microarray analyses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria

    1.Males and Females aged 18 years and older (There is no upper age limit).
    2.Histopathological evidence of ASS-negative MPM. All biopsies will be reviewed for ASS expression using immunohistochemistry. Central lab confirmation is required before randomization.
    3.Performance status ECOG ≤1. Life expectancy should be greater than 3 months (see Appendix D).
    4.No prior systemic chemotherapy for mesothelioma
    5.CT evaluable disease by modified RECIST criteria
    6.Adequate bone marrow function, or supported through treatment:
    a.Haemoglobin 10g/dl or greater.
    b.White cell count 2 x 109/L or greater, neutrophil count 1.5 x 109/L or greater
    c.Platelets 75 x 109 /L or greater.
    7.Adequate hepatic function (AST and ALT < 3 x upper limit of normal; bilirubin <1.5 x upper limit of normal)
    8.Creatinine clearance >30ml/min
    9.Able to give written informed consent to participate. NB: Translational research (tissue donation) will be dealt with by a separate informed consent form.
    E.4Principal exclusion criteria
    Exclusion Criteria

    1.Particiaption in another clinical trial using an investigational agent.
    2.Patients with surgically resectable disease
    3.Recurrent pleural effusion (not pleurodesed)
    4.Receipt of extensive radiation (hemi-thorax) therapy within 6 weeks before enrollment. Radiation to chest port sites following thoracotomy is permitted.
    5.A history of prior malignant tumour, unless the patient has been without evidence of disease for at least three years, or the tumour was a non-melanoma skin tumour or in-situ cervix carcinoma.
    6.Symptomatic or known brain or leptomeningeal metastases
    7.Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment.
    8.New York Heart Association (NYHA) Class III or IV heart failure (Attachment 10, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
    9.Serious medical (e.g. uncontrolled diabetes, hepatic disease, infection) or psychiatric illness likely to interfere with participation in this clinical study.
    10.History of seizures.
    11.Patients of child-bearing age must not become pregnant. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. All patients enrolled on the study must agree to use acceptable birth control measures whilst on the study; using both barrier and hormonal methods. Patients that are surgically sterile are also eligible to participate in this study.
    12.Females must not be breastfeeding.
    13.Prior exposure to ADI-PEG 20.
    14.Preplanned surgery or procedures that would interfere with the study protocol.
    15.Allergy to pegylated products
    E.5 End points
    E.5.1Primary end point(s)
    The rate of progression or death at 6 months after enrollment. Time to disease progression will be defined according to the modified RECIST criteria and will be measured from patient entry onto the protocol to when the disease starts to worsen
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States No
    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 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.1.1Number 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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    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)
    There is no automatic provison of ADI-PEG 20 for patients at the end of the study.

    If patients benefit from ADI-PEG 20 then future treatment decisions that include this drug, will be at the discretion of the investigator in collaboration with Polaris Pharma (who are supplying the drug for use in this study).
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-30
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