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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2010-023614-31
    Sponsor's Protocol Code Number:LA-25A-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-023614-31
    A.3Full title of the trial
    NGR019: Randomized double-blind phase II study of NGRhTNF
    versus placebo as maintenance treatment in patients with advanced
    malignant pleural mesothelioma (MPM)
    NGR019: Randomisierte, doppelblinde, Placebo-kontrollierte Phase-II-Studie zur Untersuchung von NGR-hTNF als Erhaltungstherapie bei Patienten fortgeschrittenem malignem Pleuramesotheliom (MPM).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    maintenance treatment in advanced malignant pleural mesothelioma (MPM) with NGR-hTNF
    Erhaltungstherapie bei fortgeschrittenem malignem Pleuramesotheliom (MPM) mit NGR-hTNF
    A.3.2Name or abbreviated title of the trial where available
    NGR019
    A.4.1Sponsor's protocol code numberLA-25A-001
    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 SponsorMOLMED
    B.1.3.4CountryItaly
    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 supportMOLMED SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINNOPHARMA Srl
    B.5.2Functional name of contact pointCLINICAL PROJECT MANAGER
    B.5.3 Address:
    B.5.3.1Street AddressVIA LAVORATORI AUTOBIANCHI 1
    B.5.3.2Town/ cityDESIO
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number+390362573128
    B.5.5Fax number+390362544211
    B.5.6E-maild.scanniffio@innopharma.it
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/549
    D.3 Description of the IMP
    D.3.1Product nameNGR-hTNF
    D.3.2Product code MM102
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNGR-hTNF
    D.3.9.2Current sponsor codeMM102
    D.3.9.3Other descriptive nameantineoplastic agent
    D.3.9.4EV Substance CodeSUB32556
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Yes
    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 placeboConcentrate for solution for infusion
    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
    Advanced MPM patients with non-progressive disease after
    six cycles of a first-line, pemetrexed-based regimen
    Fortgeschrittenes MPM bei Patienten ohne Krankheitsprogression nach 6 Behandlungszyklen einer Pemetrexed-basierten Erstlinientherapie
    E.1.1.1Medical condition in easily understood language
    Patients with cancer of the pleura (mesothelioma), previously treated with chemotherapy (6 cycles of pemetrexed-based chemotherapy)
    Patienten mit Krebs der Pleura (Mesotheliom), die zuvor mit Chemotherapie (6 Zyklen Pemetrexed-basierte Chemotherapie) behandelt
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10035605
    E.1.2Term Pleural mesothelioma malignant advanced
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare progression-free survival (PFS) in patients randomized to NGR-hTNF versus patients randomized to placebo
    Progressionsfreies Überleben (progression-free survival -PFS) der Patienten der NGR-hTNF-Gruppe im Vergleich zu den Patienten der Placebo-Gruppe
    E.2.2Secondary objectives of the trial
    - To compare overall survival (OS)
    - To assess tumour response in the two treatment
    arms by MPM-modified RECIST criteria
    - To evaluate safety and toxicity profile related to
    NGR-hTNF
    - To assess changes in quality of life (QoL) in the two
    treatment arms
    - Vergleich des Gesamtüberlebens (overall survival - OS)
    - Bestimmung des Ansprechens des Tumors in beiden Behandlungsarmen entsprechend der modifizierten RECIST-Kriterien für MPM
    - Evaluation des Sicherheits- und Toxizitätsprofils von NGR-hTNF
    - Bestimmung von Veränderungen der Lebensqualität (quality of life - QoL) in beiden Behandlungsarmen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
    3. Patients with non-progressive disease (i.e., complete response, partial response or stable disease) after six cycles of first-line, pemetrexed-based regimen administered for advanced or metastatic disease.
    4. ECOG Performance Status 0 - 1
    5. Life expectancy of ≥ 12 weeks
    6. Adequate baseline bone marrow, hepatic and renal function, defined as follows:
    a. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
    b. Bilirubin ≤ 1.5 x ULN
    c. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
    d. Serum creatinine < 1.5 x ULN
    7. Measurable or non-measurable disease according to MPM-modified RECIST criteria
    8. Patients may have had prior therapy providing the following conditions are met:
    a. Surgery: wash-out period of 14 days
    b. Radiation therapy: wash-out period of 28 days
    c. Chemotherapy: wash-out period of 21 days
    9. Patients must give written informed consent to participate in the study
    1. Alter ≥ 18 Jahre.
    2. Histologisch oder zytologisch nachgewiesenes malignes Pleuramesotheliom einer der folgenden Unterarten: epithelial, sarkomatoid, gemischt oder unbekannt.
    3.Patienten ohne Progression der Krankheit (d.h. komplettes Ansprechen, partielles Ansprechen oder stabile Krankheit) nach 6 Zyklen der Pemetrexed-basierten Erstlinientherapie für die fortgeschrittene oder metastierte Erkrankung.
    4. ECOG Performance Status 0 - 1
    5. Lebenserwartung ≥ 12 Wochen
    6. Adäquate Ausgangswerte für Knochenmark, Leber- und Nierenfunktion, und zwar:
    a. Neutrophile ≥ 1,5 x 109/L; Blutplättchen ≥ 100 x 109/L; Hämoglobin ≥ 9 g/dL
    b. Bilirubin ≤ 1,5 x ULN
    c. AST und/oder ALT ≤ 2,5 x ULN, wenn keine Lebermetastasen vorliegen, oder ≤ 5 x ULN bei Vorliegen von Lebermetastasen
    d. Serumkreatinin < 1,5 x ULN
    7. Messbare oder nicht messbare Krankheit entsprechend der modifizierten RECIST-Kriterien für MPM
    8. Bei Patienten, die eine vorausgegangene Therapie erhalten haben, müssen folgende Bedingungen erfüllt sein:
    a. Operation: Wash-out-Periode von 14 Tagen
    b. Strahlentherapie: Wash-out-Periode von 28 Tagen
    c. Chemotherapie: Wash-out-Periode von 21 Tagen
    9. Um an der Studie teilzunehmen, müssen die Patienten ihre schriftliche Einwilligung gegeben haben.
    E.4Principal exclusion criteria
    1. Patients must not receive any other investigational agents while on study
    2. Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
    3. Uncontrolled hypertension
    4. QTc interval (congenital or acquired) > 450 ms
    5. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke)
    6. Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
    7. Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
    8. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
    9. Pregnancy or lactation.
    1. Die Patienten dürfen keine anderen Prüfmedikamente während ihrer Teilnahme an dieser Studie erhalten.
    2. Patienten mit Myokardinfarkt in den letzten sechs Monaten, mit instabiler Angina pectoris, kongestiver Herzinsuffizienz NYHA (New York Heart Association) Grad II oder höher oder mit behandlungsbedürftigen schwerwiegenden Herzrhythmusstörungen
    3. Nicht kontrollierte Hypertonie
    4. QTc-Interval (angeboren oder erworben) > 450 ms
    5. Anamnestisch vorliegende oder bei der körperlichen Untersuchung festgestellte ZNS-Erkrankung (z. B. primärer Hirntumor, beliebige Hirnmetastasen, Krampfanfälle nicht durch eine medikamentöse Standard-Therapie kontrolliert, oder Schlaganfall in der Vorgeschichte), soweit nicht adäquat behandelt
    6. Patienten mit aktiven oder nicht behandelten systemischen Erkrankungen/Infektionen oder mit schwerwiegenden Erkrankungen bzw. klinischen Bedingungen, die mit dem Prüfplan unvereinbar sind.
    7. Bekannte Überempfindlichkeits- bzw. allergische Reaktionen gegen Humanalbumin-Präparate oder einen der Hilfsstoffe.
    8. Psychologische, familiäre, soziale oder geografische Bedingungen, welche die Compliance mit dem Prüfplan potentiell einschränken können.
    9. Schwangerschaft oder Stillzeit.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) defined as the time from the date of randomization until disease progression, or death due to any cause.
    Progressionsfreies Überleben (PFS) definiert als die Zeit von der Randomisierung bis zum Fortschreiten der Krankheit oder bis zum Tod durch beliebige Ursache.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from the date of randomization until disease progression, or death due to any cause.
    ab dem Datum von der Randomisierung bis zum Fortschreiten der Krankheit oder bis zum Tod durch beliebige Ursache.
    E.5.2Secondary end point(s)
    - Overall Survival (OS)
    - Tumour response assessment according to RECIST criteria
    - Quality of life assessment
    - Safety and tolerability
    - Gesamtüberleben (OS)
    - Bewertung des Ansprechens des Tumors nach den RECIST-Kriterien
    - Die Beurteilung der Lebensqualität
    - Sicherheit und Verträglichkeit
    E.5.2.1Timepoint(s) of evaluation of this end point
    from the date of randomization until disease progression, or death due to any cause.
    ab dem Datum von der Randomisierung bis zum Fortschreiten der Krankheit oder bis zum Tod durch beliebige Ursache.
    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 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) 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    end of the trial is defined as the date of the close out visit of the last centre
    Ende der Studie wird als Datum der Close-out-Besuch des letzten Zentrum definiert
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    none
    keiner
    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 Decision2012-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
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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
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