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    Summary
    EudraCT Number:2011-001112-53
    Sponsor's Protocol Code Number:20101129
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-21
    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 number2011-001112-53
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
    Μια Φάσης 3, Τυχαιοποιημένη, Διπλά Τυφλή, Ελεγχόμενη με Εικονικό Φάρμακο, Πολυκεντρική Μελέτη του AMG386 Μαζί με Πακλιξατέλη και Καρβοπλατίνη ως Θεραπείας Πρώτης Γραμμής σε Ασθενείς με Επιθηλιακό Καρκίνο των Ωοθηκών, Πρωτοπαθή Καρκίνο του Περιτοναίου ή Καρκίνο των Σαλπίγγων Σταδίου ΙΙΙ-ΙV κατά FIGO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of AMG 386 or placebo in combination with paclitaxel and carboplatin to treat ovarian cancer
    Μια μελέτη με AMG 386 ή εικονικού φαρμάκου σε συνδυασμό με πακλιξατέλη και καρβοπλατίνη για τη θεραπεία του καρκίνου των ωοθηκών
    A.4.1Sponsor's protocol code number20101129
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23
    B.5.3.2Town/ cityP.O. Box 1557
    B.5.3.3Post codeCH-6300 Zug
    B.5.3.4CountrySwitzerland
    B.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    B.5.6E-mailMedinfoInternational@amgen.com
    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 nameAMG 386
    D.3.2Product code AMG 386
    D.3.4Pharmaceutical form Powder 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 INNAMG 386
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeAMG 386
    D.3.9.3Other descriptive nameAMG 386
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 600
    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 placeboPowder 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
    FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
    Επιθηλιακός Καρκίνος των Ωοθηκών, Πρωτοπαθής Καρκίνος του Περιτοναίου ή Καρκίνος των Σαλπίγγων Σταδίου III-IV κατά FIGO
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    Καρκίνος των ωοθηκών
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10061269
    E.1.2Term Malignant peritoneal neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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 determine if 6 cycles of paclitaxel and carboplatin plus AMG 386 followed by 18 months of AMG 386 maintenance improves progression-free survival (PFS) compared to 6 cycles of paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo maintenance in the first-line treatment of subjects with FIGO Stage III-IV epithelial ovarian, primary peritoneal or fallopian tube cancers
    Ο προσδιορισμός του κατά πόσον 6 κύκλοι πακλιταξέλης και καρβοπλατίνης σε συνδυασμό με AMG 386 ακολουθούμενοι από 18 μήνες συντήρησης με AMG 386 βελτιώνουν την ελεύθερη εξέλιξης της νόσου επιβίωση (PFS) σε σύγκριση με 6 κύκλους πακλιταξέλης και καρβοπλατίνης σε συνδυασμό με εικονικό φάρμακο του AMG 386 ακολουθούμενους από 18 μήνες συντήρησης με εικονικό φάρμακο του AMG 386 στη θεραπεία πρώτης γραμμής ασθενών με επιθηλιακό καρκίνο των ωοθηκών, πρωτοπαθή καρκίνο του περιτοναίου ή καρκίνο των σαλπίγγων Σταδίου III-IV κατά FIGO
    E.2.2Secondary objectives of the trial
    To determine if 6 cycles of paclitaxel and carboplatin plus AMG 386 followed by 18 months of AMG 386 maintenance improves overall survival (OS) compared to 6 cycles of paclitaxel and carboplatin plus AMG 386 placebo followed by 18 months of AMG 386 placebo maintenance
    To evaluate the safety and tolerability of AMG 386 plus paclitaxel and carboplatin
    To evaluate the pharmacokinetics (PK) of AMG 386 (Cmax and Cmin)
    To estimate the incidence of anti-AMG 386 antibody formation
    To estimate the effect of AMG 386 on patient reported ovarian cancer-specific symptoms and overall health status as measured by the EuroQOL (EQ-5D) questionnairε. Due to exceeding size the rest can be found in the protocol
    Όπως αναφέρονται στην αγγλική γλώσσα
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (subjects with pseudomyxoma, mesothelioma, adenocarcinoma with unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded)

    Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization

    Subjects with FIGO Stage IIIc or IV disease must either:
    - undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
    or
    - plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer

    ECOG performance status os 0 or 1

    Adequate bone marrow, renal and hepatic funtion
    • Γυναίκες ασθενείς ηλικίας 18 ετών και άνω με επιθηλιακό καρκίνο των ωοθηκών, πρωτοπαθή καρκίνο του περιτοναίου ή καρκίνο των σαλπίγγων Σταδίου III-IV κατά FIGO με ένδειξη για θεραπεία πρώτης γραμμής με πακλιταξέλη και καρβοπλατίνη για 6 κύκλους (Οι ασθενείς με ψευδομύξωμα, μεσοθηλίωμα, αδενοκαρκίνωμα αγνώστου πρωτοπαθούς εστίας, καρκινοσάρκωμα, σάρκωμα, ιστολογικό τύπο βλεννώδους ή νευροενδοκρινούς όγκου αποκλείονται.)
    • Οι ασθενείς με νόσο Σταδίου IIIA ή IIIB κατά FIGO θα πρέπει να έχουν υποβληθεί σε PDS για καρκίνο των ωοθηκών, πρωτοπαθή καρκίνο του περιτοναίου ή καρκίνο των σαλπίγγων εντός 12 εβδομάδων πριν από την τυχαιοποίηση
    • Οι ασθενείς με νόσο Σταδίου IIIC ή IV κατά FIGO θα πρέπει:
    o Είτε να υποβληθούν σε PDS για επιθηλιακό καρκίνο των ωοθηκών, πρωτοπαθή καρκίνο του περιτοναίου ή καρκίνο των σαλπίγγων εντός 12 εβδομάδων πριν από την τυχαιοποίηση
    ΕΙΤΕ
    o Να έχει προγραμματιστεί να υποβληθούν σε IDS μετά από 3 κύκλους χορήγησης πακλιταξέλης και καρβοπλατίνης συν AMG 386 ή εικονικό φάρμακο του AMG 386 (βλ. Ενότητα 6.4.1) για αποδεδειγμένο βάσει βιοψίας επιθηλιακό καρκίνο των ωοθηκών, πρωτοπαθή καρκίνο του περιτοναίου ή καρκίνο των σαλπίγγων
    • Κατάσταση Απόδοσης κατά ECOG 0 ή 1
    • Επαρκής λειτουργία μυελού των οστών, των νεφρών και του ήπατος.
    E.4Principal exclusion criteria
    Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancers

    Previous abdonimal and/or pelvic external beam radiotherapy

    History of central nervous metastasis

    History of arterial or venous thromboembolism within 12 months prior to randomization

    Clinically significant cardiovascular disease within 12 months prior to randomization
    • Προηγούμενη χρήση οποιασδήποτε αντικαρκινικής θεραπείας ή πειραματικής θεραπείας για επιθηλιακό καρκίνο των ωοθηκών, πρωτοπαθή καρκίνο του περιτοναίου ή καρκίνο των σαλπίγγων
    • Προηγούμενη ακτινοθεραπεία εξωτερικής δέσμης στην κοιλιακή χώρα ή/και την πύελο
    • Ιστορικό μετάστασης στο κεντρικό νευρικό σύστημα
    • Ιστορικό αρτηριακής ή φλεβικής θρομβοεμβολής εντός 12 μηνών πριν από την τυχαιοποίηση
    • Κλινικά σημαντική καρδιαγγειακή νόσος εντός 12 μηνών πριν από την τυχαιοποίηση.
    E.5 End points
    E.5.1Primary end point(s)
    Pogression Free Survival (PFS)
    PFS is defined as the time from the randomization date to the earlier of the dates of (1) the first objective disease progression per RECIST 1.1 with modifications (see protocol for details) or (2) death from any cause.
    Ελεύθερη εξέλιξης της νόσου επιβίωση
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim analysis – 438 PFS events (21 months post FSE)
    Primary analysis – 719 PFS events (3 months post completion of accrual)
    Ενδιάμεση ανάλυση - 438PFS (21 Μήνες μετά από FSE)
    Πρωταρχική ανάλυση - 719 PFS (3 μήνες μετά την ολοκλήρωση accrual)
    E.5.2Secondary end point(s)
    • Overall Survival (OS)
    OS is defined as the time from the randomization date to the date of death from any cause. Subjects who have been lost to follow-up before the analysis data cutoff date or otherwise have not died by the analysis data cutoff date will be censored at their last
    contact date (last known to be alive)
    • Incidence of adverse events and significant laboratory abnormalities
    • Pharmacokinetics of AMG 386 (Cmax and Cmin)
    • Incidence of anti-AMG 386 antibody formation
    • Patient reported ovarian cancer-specific symptoms and health related quality of life
    • Patient reported health status as measured by the EQ-5D
    • AMG 386 exposure-response relationships for PFS and OS
    • Correlation of serum biomarkers with measures of response
    Συνολική επιβίωση
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interim analysis – 477 OS events (33 months post FSE)
    Primary analysis – 900 OS events (54 months post FSE
    Ενδιάμεση ανάλυση - 477 OS (33 Μήνες μετά από FSE)
    Πρωταρχική ανάλυση - 900 OS (54 μήνες μετά FSE
    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 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) 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA175
    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
    European Union
    Canada
    Hong Kong
    Japan
    Korea, Republic of
    Russian Federation
    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
    End of Study: earlier time of 72 months after the last subject has been randomized or when all subjects have died, withdrawn full consent, or have been lost to follow-up.
    Λήξη της μελέτης:
    Νωρίτερα από: 72 μήνες μετά την τυχαιοποίηση του τελευταίου ασθενούς ή όταν όλοι οι ασθενείς έχουν αποβιώσει, ή έχουν αποσύρει τη συγκατάθεση τους ή έχει καταστεί αδύνατο να παρακολουθηθούν.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months6
    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: 1400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 2000
    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 Oncological Trials (ENGOT)
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-05
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