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    Summary
    EudraCT Number:2014-003812-36
    Sponsor's Protocol Code Number:MORAb-003-011
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-26
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-003812-36
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer.
    A.4.1Sponsor's protocol code numberMORAb-003-011
    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 Europe Ltd
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442086001400
    B.5.5Fax number+442086001401
    B.5.6E-mailLMedinfo@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 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 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 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 typeequal
    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 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 Yes
    D.3.11.13.1Other medicinal product typeHumanised monoclonal antibody to folate receptor alpha (FRA)
    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 placeboSolution 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
    Serious epithelial ovarian cancer including primary peritoneal and fallopian tube malignancies
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033160
    E.1.2Term Ovarian epithelial cancer recurrent
    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
    To demonstrate that farletuzumab has superior efficacy compared with placebo in improving PFS, as determined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 (Eisenhauer, et al., 2009), when added to the standard chemotherapy regimens of carboplatin plus paclitaxel or carboplatin plus PLD, in subjects with platinum-sensitive ovarian cancer in first relapse who have a CA125 ≤ 3xULN (105 U/mL) at study entry.
    E.2.2Secondary objectives of the trial
    •To assess the effect of farletuzumab on overall survival (OS) in this population
    •To assess the effect of farletuzumab in prolonging second platinum-free interval longer than first platinum-free interval
    •To assess the effect of farletuzumab on best objective response (OR) rate, time to response (TTR) and duration of response (DR) by RECIST 1.1 criteria
    •To assess the safety and tolerability of farletuzumab
    •To assess the pharmacokinetics and exposure-response relationships between farletuzumab and PFS and OS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Female subjects who are at least 18 years of age at the time of informed consent
    2.CA125 ≤3 x ULN (105 U/mL) confirmed within 2 weeks of randomization using a centralized laboratory assay
    3.A histologically confirmed diagnosis of high-grade serous epithelial ovarian cancer including primary peritoneal and fallopian tube malignancies; all other histologies, including mixed histology, are excluded
    4.Have been treated with debulking surgery and a first-line platinum-based chemotherapy regimen
    5.Maintenance therapy during the first platinum-free interval is allowed; however, the last dose must have been at least 21 days prior to Randomization.
    6.Must be in a first relapse and have evaluable disease by CT or MRI scan, according to RECIST 1.1 (subjects with measurable disease per RECIST 1.1 or radiographically visible and evaluable disease). Subjects with only ascites or pleural effusion are excluded. See Appendix 4.
    7.Must have relapsed radiographically within ≥6 months and ≤36 months of first-line platinum chemotherapy
    8.Must be a candidate for treatment with either carboplatin plus paclitaxel or carboplatin plus PLD with no medical contraindications present as outlined in the product labels for the selected regimen to be used in this study
    9.Have a life expectancy of at least 6 months, as estimated by the investigator
    10.Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Randomization
    11.Have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 2
    12.Subjects being enrolled to receive paclitaxel plus carboplatin treatment must have neuropathic function (sensory and motor) ≤ Grade 2 according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (National Cancer Institute, 2010)
    13.Laboratory results within the 2 weeks prior to Randomization must be as follows:
    -Absolute neutrophil count (ANC) ≥1,500 cells/mm3
    -Platelet count ≥100,000 cells/mm3
    -Hemoglobin ≥9 g/dL
    -Creatinine <1.5xULN (CTCAE Grade 1)
    -Bilirubin <1.5xULN (CTCAE Grade 1)
    -Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ˂3xULN (CTCAE Grade 1)
    -Alkaline Phosphatase <2.5xULN (CTCAE Grade 1)
    -Baseline albumin ≥ Lower Limit of Normal
    14.Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. All females will be considered to be of childbearing potential unless they are postmenopausal (eg, amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). If a patient of childbearing potential is neither surgically sterile nor postmenopausal, a highly-effective contraceptive method (ie, a method that can achieve a failure rate of less than 1% per year when used consistently and correctly) must start either prior to or at Screening and continue throughout the entire study period and for 6 months after the last dose of Test Article is administered. Pregnant and/or lactating females are excluded
    15.Subject must provide written informed consent and be willing and able to comply with all aspects of the protocol
    E.4Principal exclusion criteria
    1.Known central nervous system (CNS) tumor involvement
    2.Evidence of other active invasive malignancy requiring treatment other than surgery in the past 3 years
    3.Clinically significant heart disease (eg, congestive heart failure of New York Heart Association Class 3 or 4, angina not well controlled by medication, or myocardial infarction within 6 months)
    4.Electrocardiogram (ECG) demonstrating clinically significant arrhythmias that are not adequately medically managed (Note: subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible)
    5.Active serious systemic disease, including active bacterial or fungal infection
    6.Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary.
    7.Other concurrent immunotherapy (eg, immunosuppressants or chronic use of systemic corticosteroids, with the exception that low-dose corticosteroids [50 mg/day prednisone or equivalent corticosteroid] are allowed; these should be discussed with the Medical Monitor)
    8.Known allergic reaction to a prior monoclonal antibody therapy or have any documented Anti-Drug Antibody (ADA) response; additionally known allergic reaction to the concomitant chemotherapies selected by the investigator for planned treatment in this study unless desensitization is planned.
    9.Previous treatment with farletuzumab or other folate receptor targeting agents
    10.Previous treatment with cancer vaccine therapy
    11.For subjects being enrolled to receive carboplatin plus PLD, prior treatment with anthracyclines or anthracenodiones
    12.Breast-feeding, pregnant, or likely to become pregnant during the study
    13.Any medical or other condition that, in the opinion of the investigator, would preclude the subject’s participation in a clinical study including medical contraindications as outlined in the product labels for the chemotherapies selected by the investigator for planned treatment in this study
    14. Patients who have had secondary debulking surgery or any second line therapy
    15.Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 x half-life for investigational drugs where the half-life is known) preceding informed consent
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is PFS based on the investigators’ radiographic assessments utilizing RECIST 1.1 criteria. If progression or death is not observed for a subject, the PFS time will be censored at the date of last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment or the cut-off date, whichever is earliest. Detailed censoring rules will be outlined in the SAP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS is defined as the time (in months) from the date of randomization to the date of the first observation of progression (RECIST 1.1), or date of death, whatever the cause.
    E.5.2Secondary end point(s)
    OS: Defined as the time from the date of randomization to the date of death, due to all causes. If death is not observed for a subject, the OS time will be censored at the last date known to be alive or the cut-off date, whichever is earliest.

    Length of First vs Second Platinum-Free Interval: Length of first platinum-free interval is defined as the period of time (in months) from the date of completion of previous platinum based chemotherapy until date of first relapse (ie, first observation of progression), as recorded on the eCRF. The date of first relapse is the progression date based on a radiographic assessment. Similarly, length of second platinum-free interval is defined as the period of time (in months) from the date of completion of platinum based chemotherapy (last dosing date) during the study until the date of progression based on the investigator’s radiographic assessment (RECIST 1.1).

    Tumor Response (OR, TTR, DR per RECIST 1.1): OR is defined as either a CR or a PR using RECIST 1.1 criteria. Tumor assessments performed up to the initiation of further anticancer treatment will be considered. TTR is defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR). DR is defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression based on the investigator’s radiographic assessment (RECIST 1.1), or date of death, whatever the cause.
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: Defined as the time from the date of randomization to the date of death, due to all causes.
    Length of first platinum-free interval is defined as the period of time (in months) from the date of completion of previous platinum based chemotherapy until date of first relapse.
    Tumor Response: OR is defined as either a Complete response or a Partial response using RECIST 1.1 criteria. Time To Response is defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR). Duration of Response is defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression based on the investigator’s radiographic assessment (RECIST 1.1), or date of death, whatever the cause.
    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 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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    Belgium
    Germany
    Italy
    Japan
    Spain
    United Kingdom
    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
    LVLS
    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 months4
    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: 146
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 210
    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)
    At the time of the completion of the study by the sponsor, provisions will be made to allow for continued treatment of subjects who have not yet experienced disease progression and are receiving Test Article as long as the efficacy endpoints of the trial have been met. In the event the study is terminated and the efficacy endpoints have not been met, all subjects will be required to discontinue Test Article administration.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Network of Gynaecological Trial, Geneva,
    G.4.3.4Network Country Switzerland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-13
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