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    Summary
    EudraCT Number:2008-005448-18
    Sponsor's Protocol Code Number:MORAb-009-003
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-25
    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 - PEI
    A.2EudraCT number2008-005448-18
    A.3Full title of the trial
    An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
    A.4.1Sponsor's protocol code numberMORAb-009-003
    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 SponsorMorphotek, Inc.
    B.1.3.4CountryUnited States
    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 supportMorphotek, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Ltd
    B.5.2Functional name of contact pointMedical Information Department
    B.5.3 Address:
    B.5.3.1Street AddressEuropean Knowledge Centre, Mosquito Way
    B.5.3.2Town/ cityHatfield, Herfordshire
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 800 001 4612
    B.5.5Fax number+44 845 676 1388
    B.5.6E-mailEUmedinfo@eisai.net
    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 nameChimeric Antibody to Mesothelin
    D.3.2Product code MORAb-009
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNamatuximab
    D.3.9.2Current sponsor codeMORAb-009
    D.3.9.3Other descriptive nameChimeric Antibody to Mesothelin, amatuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced pleural mesothelioma
    E.1.1.1Medical condition in easily understood language
    mesothelioma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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
    The primary objective is to determine the effect on PFS of adding MORAb-009 (amatuximab) to the combination of pemetrexed and cisplatin in the treatment of subjects with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy, as assessed by the modified RECIST for the assessment of response in malignant pleural mesothelioma
    E.2.2Secondary objectives of the trial
    • Evaluate antitumor activity, as assessed by objective tumor response (overall response rate [ORR]).
    • Evaluate duration of response (DR).
    • Evaluate overall survival (OS).
    • Determine the safety and tolerability of MORAb-009 when administered with pemetrexed and cisplatin.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENOMIC SUB-STUDY, 17 June 2008, MORAb-009-003

    The exploratory objectives are to:
    •Molecular Marker Analysis

    IMMUNE RESPONSE SUB-STUDY, 17 June 2008, MORAb-009-003

    The objective is to study how immune system responds to mesothelin and other proteins that may be present in this type of cancer
    E.3Principal inclusion criteria
    1. Female or male and ≥ 18 years of age.
    2. Life expectancy of at least 3 months.
    3. Confirmed diagnosis of MPM with the following characteristics: • Unresectable disease (or otherwise not a candidate for curative surgery)
    • Epithelial type or biphasic (mixed) type with low sarcomatous content.
    4. Measurable disease at Screening
    5. KPS of ≥ 70% at Screening (Appendix 3).
    6. Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Day 1.
    7. Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:
    Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    Platelet count ≥ 100 x 109/L
    Hemoglobin ≥ 9 g/dL
    Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
    Aspartate transaminase (AST)* ≤ 2.5 x ULN
    Alanine transaminase (ALT)* ≤ 2.5 x ULN
    Alkaline phosphatase * ≤ 3 x ULN
    Serum creatinine ≤ 2.0 mg/dL
    * Subjects with liver function abnormalities greater than the ULN specified above are eligible only if, in the opinion of the investigator, these abnormalities are due to disease obstruction of the bile ducts or metastatic disease. Stenting to reduce liver functions to qualifying levels is permitted.
    8. Calculated serum creatinine clearance ≥ 60 mL/min using the Cockroft Gault equation (Appendix 7).
    9. Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial and for at least 8 weeks (ie, 5 half-lives of MORAb-009) following administration of the last dose of MORAb 009.
    10. Willingness and ability to provide written informed consent.
    E.4Principal exclusion criteria
    1. Mesothelioma of the sarcomatous type or disease located primarily in the peritoneum.
    2. Prior systemic therapy or radiotherapy for mesothelioma; prior treatment with local radiotherapy for symptom control (ie, non-curative intent) is permitted.
    3. Known central nervous system (CNS) tumor involvement.
    4. Evidence of other active malignancy requiring treatment.
    5. Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months).
    6. Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection.
    7. Clinically significant arrhythmias demonstrated on ECG (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible).
    8. Active, serious systemic disease, including active bacterial or fungal infection.
    9. Treatment within 3 months of the start of the trial with other immunomodulatory therapy (e.g., interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Low-dose treatment with or short term use of systemic corticosteroids, topical or intra-articular steroids is acceptable, subject to the judgment of the investigator.
    10. Known hypersensitivity to any of the following: monoclonal antibodies or biologic therapy, pemetrexed or ingredients used in the formulation of pemetrexed, cisplatin or other platinum containing compounds.
    12. Subjects who are Breast-feeding, pregnant, or likely to become pregnant during the clinical trial.
    13. Subjects who are unable or unwilling to sign the trial informed consent form (ICF).
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    • PFS at 6 months
    PFS is defined as time from date of first dose of investigational product to date of disease progression or death due to any cause. Subjects who receive new anti-cancer therapy before disease progression will have their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy is initiated
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS at 6m: disease assessed at screening, D8 of the third 21d-cycle, D8 of every third 21d-cycle thereafter, and at the exit visit
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • ORR
    • DR
    • OS
    Exploratory endpoints:
    • Improvement in Pulmonary Function Tests
    • Change in Karnofsky Performance Status
    • Change in CA-125 levels
    • HLA subtype
    • Molecular marker analysis
    • Humoral and T cell responses to mesothelin
    Safety endpoints:
    • Assessment of AEs, including AEs of interest (AEIs), clinical laboratory parameters (hematology, serum chemistry and urinalysis), physical examination (including vital sign assessment), 12-lead electrocardiogram (ECG) and human anti-chimeric antibodies (HACA) development.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PD, DR, ORR: disease assessed at screening, D8 of the third 21d-cycle, D8 of every third 21d-cycle thereafter, and at the exit visit
    OS: every 4 weeks for the treatment cycles then every month during follow-up
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Germany
    Netherlands
    Spain
    United States
    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
    The Final visit will be conducted after evidence of disease progression has been identified.
    After the Final/Early Termination visit, subjects will be contacted monthly for the first 9 months, and every other month thereafter by investigational site personnel.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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.1.1.1.1Number 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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 86
    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)
    It is not different from the expected normal treatment of that condition
    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 Decision2009-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-31
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