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    Summary
    EudraCT Number:2008-005872-29
    Sponsor's Protocol Code Number:MORAb-003-004
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-10-22
    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 ConcernedGreece - EOF
    A.2EudraCT number2008-005872-29
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse
    A.4.1Sponsor's protocol code numberMORAb-003-004
    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 SponsorEisai Limited
    B.1.3.4CountryUnited Kingdom
    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 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/535
    D.3 Description of the IMP
    D.3.1Product nameFarletuzumab
    D.3.2Product code MORAb-003
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNFarletuzumab
    D.3.9.1CAS number 896723-44-7
    D.3.9.2Current sponsor codeMORAb-003
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 5.5
    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) 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 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 placeboIntravenous 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
    First relapse of platinum-sensitive non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033160
    E.1.2Term Ovarian epithelial cancer recurrent
    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 effect of two dose levels of MORAb-003 or placebo in combination with carboplatin and taxane on progression-free survival (PFS), as determined by RECIST, in subjects with platinum-sensitive ovarian cancer in first relapse.
    E.2.2Secondary objectives of the trial
    •To assess the effect of MORAb-003 on overall survival (OS)
    •To assess the effect of MORAb-003 on CA-125 defined PFS and serologic response, based on Rustin criteria
    •To assess the effect of MORAb-003 to prolong second remission longer than first remission
    •To assess the effect of MORAb-003 on best objective response (OR) rate, time to response (TTR) and duration of response (DR) by RECIST criteria
    •To compare the serologic response of low- (1.25 mg/kg) and high- (2.5 mg/kg) dose MORAb-003 to each other in combination with carboplatin and taxane, and to placebo plus carboplatin and taxane
    •To assess the safety and tolerability of both dose levels of MORAb-003
    •To assess the effect of MORAb-003 on subject-reported on Quality of Life (QoL)
    •To assess the effect of MORAb-003 on resource utilization
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETIC SUB-STUDY IN ASSOCIATION WITH STUDY MORAb-003-004:
    •To determine if a pharmacokinetic interaction exists between MORAb-003 and carboplatin, paclitaxel, or docetaxel with a PK drug-drug interaction (DDI) sub-study

    PHARMACOGENOMIC SUB-STUDY IN ASSOCIATION WITH STUDY MORAb-003-004:
    •Examination of genomic DNA, serum, or archived tumor tissue to identify molecular markers as a surrogate for immunotherapy response.
    E.3Principal inclusion criteria
    1.Female subjects ≥18 years of age
    2.Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. Contraceptive measures must start either prior to or at screening and continue throughout the entire study period and for 2 months after the last dose of study drug is administered. Pregnant and/or lactating females are excluded
    3.A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
    4.Must have measurable disease by CT or MRI scan
    5.Must have relapsed radiologically within ≥6 and ≤ 24 months of completion of first-line platinum/taxane chemotherapy
    6.Must be a candidate for repeat carboplatin/taxane therapy
    7.Life expectancy of ≥6 months as estimated by the investigator
    8.Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1
    9.Karnofsky performance status (KPS) ≥70%
    10.Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

    Absolute neutrophil count (ANC) ≥ 1.5 x 10*9/L
    Platelet count ≥ 100 x 10*9/L
    Hemoglobin ≥ 9 g/dL
    Creatinine ≤1.5x ULN (CTCAE Grade 1)
    Bilirubin < 1.5x ULN (CTCAE Grade 1)
    Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase < 2.5 x ULN (CTCAE Grade 1)

    11.Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1
    12.Subject must provide written informed consent and be able to comply with the protocol procedures
    (*=to the power)
    E.4Principal exclusion criteria
    1.Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy
    2.Subjects who have received other therapy to treat their ovarian cancer since relapse
    3.Known central nervous system (CNS) tumor involvement
    4.Evidence of other active invasive malignancy requiring treatment in the past 5 years
    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.Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible)
    7.Active serious systemic disease, including active bacterial or fungal infection
    8.Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary.
    9.Other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed)
    10.Known allergic reaction to a prior monoclonal antibody therapy or have any documented
    HAHA
    11.Previous treatment with MORAb-003 (farletuzumab)
    12.Clinical contraindications to use of a taxane
    13.Prior treatment with any investigational agent within 4 weeks of study entry
    14.Breast-feeding, pregnant, or likely to become pregnant during the study
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) is the primary efficacy endpoint, defined as the time from randomization to progression by RECIST (as measured using independent review of CT/MRI scans as outlined in the Central Radiology Charter and Statistical Analysis Plan), or death from all causes.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 900
    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 Decision2009-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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