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    Summary
    EudraCT Number:2011-001112-53
    Sponsor's Protocol Code Number:20101129
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-24
    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 ConcernedSpain - AEMPS
    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
    Estudio multicéntrico de fase 3, aleatorizado, doble ciego y controlado con placebo de AMG 386 con paclitaxel y carboplatino como tratamiento de primera línea para sujetos con cáncer epitelial de ovario, peritoneal primario o de trompas de Falopio en estadio III-IV de la 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
    Estudio de AMG 386 o placebo en combinación con paclitaxel y carboplatino como tratamiento de cáncer de ovario
    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
    Cáncer epitelial de ovario, peritoneal primario o de trompas de Falopio en estadio III-IV de la FIGO
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    Cáncer de ovario
    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
    Determinar si 6 ciclos de paclitaxel y carboplatino más AMG 386 seguidos de 18 meses de mantenimiento con AMG 386 mejoran la supervivencia libre de progresión (SLP) en comparación con 6 ciclos de paclitaxel y carboplatino más placebo de AMG 386 seguidos de 18 meses de mantenimiento con placebo de AMG 386 en el tratamiento de primera línea de sujetos con cáncer epitelial de ovario, cáncer peritoneal primario y cáncer de las trompas de Falopio en estadio III-IV de la 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) questionnaire.

    To evaluate AMG 386 exposure-response relationships for PFS and OS.

    To investigate potential biomarker development based on assessment of blood samples and tumor samples, genetic analysis of tumor samples, the proposed mechanism of action of AMG 386 and response.
    Determinar si 6 ciclos de paclitaxel y carboplatino más AMG 386 seguidos de 18 meses de mantenimiento con AMG 386 mejoran la supervivencia global (SG) en comparación con 6 ciclos de paclitaxel y carboplatino más placebo de AMG 386 seguidos de 18 meses de mantenimiento con placebo de AMG 386.

    Evaluar la seguridad y la tolerabilidad de AMG 386 más paclitaxel y carboplatino.

    Evaluar la farmacocinética (PK) de AMG 386 (Cmáx y Cmín).

    Estimar la incidencia de la formación de anticuerpos anti-AMG 386.

    Estimar el efecto de AMG 386 sobre el estado general de salud notificado por el paciente, medido según el cuestionario EuroQOL (EQ-5D).

    Evaluar las relaciones respuesta-exposición de AMG 386 para la SLP y la SG.

    Investigar el desarrollo de un posible biomarcador a partir de la evaluación de muestras sanguíneas y tumorales, análisis genético de muestras tumorales y el mecanismo de acción propuesto de AMG 386 y su respuesta.
    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
    Mujeres de como mínimo 18 años con cáncer epitelial de ovario, cáncer peritoneal primario o cáncer de las trompas de Falopio en estadio III-IV de la FIGO que tengan indicado el tratamiento de primera línea con paclitaxel y carboplatino x 6 ciclos (los sujetos con pseudomixoma, mesotelioma, adenocarcinoma de tumor primario desconocido, carcinosarcoma, sarcoma o histología neuroendocrina o mucinosa quedan excluidos)

    Los sujetos con enfermedad en estadio IIIA o IIIB de la FIGO deben haberse sometido a CCP para el cáncer de ovario, el cáncer peritoneal primario o el cáncer de las trompas de Falopio en las 12 semanas previas a la aleatorización

    Los sujetos con enfermedad en estadio IIIC o IV de la FIGO deben:
    - someterse a CCP para el cáncer epitelial de ovario, el cáncer peritoneal primario o el cáncer de las trompas de Falopio en las 12 semanas previas a la aleatorización
    o
    - tener la previsión de someterse a CCI después de 3 ciclos de paclitaxel y carboplatino más AMG 386 o placebo de AMG 386 para el cáncer epitelial de ovario, el cáncer peritoneal primario o el cáncer de las trompas de Falopio demostrado por biopsia

    Estado funcional ECOG de 0 o 1

    Función renal, hepática y de la médula ósea adecuadas
    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
    Uso anterior de cualquier tratamiento anticancerígeno o tratamiento experimental para cáncer epitelial de ovario, cáncer peritoneal primario o cáncer de las trompas de Falopio

    Radioterapia de haz externo abdominal y/o pélvica previa

    Antecedentes de metástasis en el sistema nervioso central

    Antecedentes de tromboembolismo venoso o arterial en los 12 meses previos a la aleatorización

    Enfermedad cardiovascular clínicamente significativa en los 12 meses previos a la aleatorización
    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.
    La Supervivencia Libre de Progresión (SLP)
    La SLP se define como el período desde la fecha de aleatorización hasta la primera de las fechas de (1) la primera progresión de la enfermedad objetiva según RECIST 1.1 con modificaciones (ver el protocolo para más detalles) o (2) muerte por cualquier causa.
    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)
    Análisis intermedio - 438 acontecimientos SLP (21 meses después de la aleatorización del primer sujeto)
    Análisis principal - 719 acontecimientos SLP (3 meses después de finalizar la inclusión)
    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
    - Supervivencia Global (SG)
    La SG se define como el período desde la fecha de aleatorización hasta la fecha de la muerte por cualquier causa. Los sujetos perdidos en el seguimiento antes de la fecha de corte de los datos o que alternativamente no hayan muerto en la fecha corte de los datos se censurarán en su última fecha de contacto (la última en la que se supo que estaban vivos)
    - Incidencia de acontecimientos adversos y anomalías analíticas significativas
    - Farmacocinética de AMG 386 (Cmáx y Cmín)
    - Incidencia de formación de anticuerpos anti-AMG 386
    - Los síntomas específicos del cáncer de ovario notificados por la paciente y la calidad de vida relacionada con la salud
    - Estado de salud notificado por el paciente según la medición del EQ-5D
    - Relaciones respuesta-exposición de AMG 386 para la SLP y la SG
    - Correlación de los biomarcadores séricos con las medidas de respuesta
    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)
    Análisis intermedio - 477 acontecimientos SG (33 meses después de la aleatorización del primer sujeto)
    Análisis principal - 900 acontecimientos SG (54 meses después de la aleatorización del primer sujeto)
    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 concerned8
    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.
    Fin del estudio: Momento anterior a los 72 meses después en que se ha aleatorizado al último sujeto o en que todos los sujetos han muerto, han retirado su pleno consentimiento o se han perdido en el seguimiento.
    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 state72
    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)
    N/A
    N/A
    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 Decision2012-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-05
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