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    Summary
    EudraCT Number:2011-001112-53
    Sponsor's Protocol Code Number:20101129
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-02
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio multicentrico di fase 3, randomizzato, in doppio cieco con controllo placebo sull'uso di AMG 386 in associazione a paclitaxel e carboplatino come trattamento di prima linea su pazienti con carcinoma epiteliale ovarico, carcinoma peritoneale primario o cancro delle tube di Falloppio di stadio FIGO III-IV.
    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
    Studio con AMG386 o placebo in associazione con paclitaxel e
    carboplatin per il trattamneto del cancro ovarico
    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 Dompe' SpA
    B.5.2Functional name of contact pointDipartimento Regolatorio
    B.5.3 Address:
    B.5.3.1Street AddressVia E. Tazzoli, 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number+39026241121
    B.5.5Fax number+390229005596
    B.5.6E-mailgbotta@amgendompe.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 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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAMG 386
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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
    Carcinoma epiteliale ovarico, carcinoma peritoneale primario o cancro delle tube di Falloppio di stadio FIGO III-IV
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    Carcinoma ovarico
    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 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 14.1
    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 progressionfree
    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 IIIIV
    epithelial ovarian, primary peritoneal or fallopian tube cancers
    Determinare se 6 cicli di paclitaxel e carboplatino in associazione a AMG 386 seguiti da 18 mesi
    di terapia di mantenimento con AMG 386 migliorano la sopravvivenza libera da progressione
    (PFS) rispetto a 6 cicli di paclitaxel e carboplatino in associazione a AMG 386 placebo seguiti da
    18 mesi di terapia di mantenimento con AMG 386 placebo nel trattamento di prima linea di
    pazienti con carcinoma epiteliale ovarico, carcinoma peritoneale primario o cancro delle tube di
    Falloppio di stadio FIGO III-IV.
    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.
    Stabilire se 6 cicli di paclitaxel e carboplatino in associazione a AMG 386 seguiti da 18 mesi di
    terapia di mantenimento con AMG 386 migliorano la sopravvivenza
    complessiva (OS) rispetto
    a 6 cicli di paclitaxel e carboplatino in associazione a AMG 386 placebo seguiti da 18 mesi di
    terapia di mantenimento con AMG 386 placebo.
    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.
    • Soggetti di sesso femminile, di età ≥18 anni, con carcinoma epiteliale ovarico, carcinoma
    peritoneale primario o cancro delle tube di Falloppio di stadio FIGO III-IV con indicazione
    al trattamento di prima linea con paclitaxel e carboplatino per 6 cicli
    o Sono esclusi i soggetti con pseudomixoma, mesotelioma, adenocarcinoma con
    tumore primario sconosciuto, carcinosarcoma, sarcoma e istologia mucinosa o
    neuroendocrina
    • I soggetti con malattia di stadio FIGO IIIA o IIIB devono essere stati sottoposti a PDS per
    carcinoma ovarico, carcinoma peritoneale primario o cancro delle tube di Falloppio nelle
    12 settimane precedenti la randomizzazione
    • I soggetti con malattia di stadio FIGO IIIC o IV devono:
    o sottoporsi a PDS per carcinoma epiteliale ovarico, carcinoma peritoneale
    primario o cancro delle tube di Falloppio nelle 12 settimane precedenti la
    randomizzazione
    OPPURE
    o programmare un intervento di IDS dopo il completamento di 3 cicli di paclitaxel e
    carboplatino in associazione a AMG 386 o AMG 386 placebo per carcinoma epiteliale ovarico, carcinoma peritoneale primario o cancro
    delle tube di Falloppio documentati da biopsia,
    • Performance status ECOG pari a 0 o 1
    • Adeguata funzionalità del midollo osseo, renale ed epatica.
    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
    Precedente utilizzo di terapia antitumorale o di terapia sperimentale per carcinoma
    epiteliale ovarico, carcinoma peritoneale primario o cancro delle tube di Falloppio
    • Precedente radioterapia esterna addominale e/o pelvica
    • Storia di metastasi al sistema nervoso centrale
    • Storia di tromboembolia arteriosa o venosa nei 12 mesi precedenti la randomizzazione
    • Malattia cardiovascolare clinicamente significativa nei 12 mesi precedenti la
    randomizzazione
    E.5 End points
    E.5.1Primary end point(s)
    PFS - Pogression Free Survival
    PFS - Pogression Free Survival (Sopravvivenza libera da progressione)
    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)
    Interim analysis – 438 eventi di PFS (21 mesi dopo che il primo soggetto è stato arruolato)
    Primary analysis – 719 eventi di PFS (3 mesi dopo il completamento dell'accrual)
    E.5.2Secondary end point(s)
    • Overall Survival (OS)
    • 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
    • Overall Survival (OS)
    • Incidenza di eventi avversi e anomalie di laboratorio significative
    • Farmacocinetica di AMG 386 (Cmax e Cmin)
    • Incidenza della formazione di anticorpi anti-AMG 386
    • Qualità di vita correlata allo stato di salute (HRQoL) e sintomi specifici per il carcinoma
    ovarico riferiti dalla paziente e misurati mediante il questionario FACT-O e FACT-O OCS
    • Stato di salute complessivo riferito dal paziente, valutato mediante EQ-5D
    • Rapporti esposizione-risposta per AMG 386 in relazione alla PFS e alla OS
    • Correlazione tra i biomarcatori sierici e i parametri di risposta
    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
    Interim analysis – 477 eventi di OS (33 mesi dopo che il primo soggetto è stato arruolato)
    Primary analysis – 900 eventi di OS (54 mesi dopo che il primo soggetto è stato arruolato)
    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 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 concerned15
    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
    Canada
    Hong Kong
    Japan
    Korea, Democratic People's Republic of
    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.
    End of Study: la prima situazione che si verifica 72 mesi dopo che l'ultimo soggetto è stato randomizzato o quando tutti i soggetti sono deceduti, hanno ritirato il consenso o sono stati persi al follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months102
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months102
    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.1.1Number of subjects for this age range: 0
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 2000
    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)
    NA
    NA
    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 MaNGO - Mario Negri Gynecological and Oncology group
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation MITO - Multicenter Italian Trials in Ovarian cancer and and gynecological malignances
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
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