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    Summary
    EudraCT Number:2017-002992-25
    Sponsor's Protocol Code Number:20140346
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial 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 number2017-002992-25
    A.3Full title of the trial
    A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic or Colorectal Cancer.
    Studio su romiplostim di Fase III, randomizzato, controllato verso placebo, in doppio cieco per il trattamento della trombocitopenia indotta da chemioterapia in pazienti trattati con chemioterapia a base di Oxaliplatino per il trattamento del cancro gastrointestinale, pancreatico o colorettale.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study is to learn more about the study drug romiplostim in people with chemotherapy-induced thrombocytopenia (CIT) receiving chemotherapy for the treatment of gastrointestinal, pancreatic or colorectal cancer.
    Questo studio è per saperne di più sulla molecola in studio romiplostim nei soggetti con trombocitopenia indotta da chemioterapia che ricevono chemioterapia per il trattamento di cancro gastrointestinale, pancreatico o colorettale.
    A.3.2Name or abbreviated title of the trial where available
    Study of Romiplostim for CIT in in Adult Subjects with Gastrointestinal or Colorectal Cancer.
    studio su romiplostim per CIT in soggetti adulti affetti da cancro gastrointestinale o colorettale
    A.4.1Sponsor's protocol code number20140346
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03362177
    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 S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number0039026241121
    B.5.6E-mailmedicalinformationitaly@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 Yes
    D.2.1.1.1Trade name NPLATE - 500MCG-POLV.500MCG(500/ML)E SOLV. 1.2 ML IN SIRINGA PRERIEMPITA PER SOL. INIET.-USO SC 1FLACONC.+1SIR PRER+1ADATTATORE+1AGO+1SIRINGA+4TAMP. ALC00L
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameromiplostim
    D.3.2Product code [AMG 531]
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROMIPLOSTIM
    D.3.9.1CAS number 267639-76-9
    D.3.9.2Current sponsor codeAMG 531
    D.3.9.4EV Substance CodeSUB27756
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    gastrointestinal or colorectal adenocarcinoma, which includes cancers of the esophagus, stomach, colon, or rectum.
    adenocarcinoma gastrointestinale o colorettale, inclusi cancro all'esofago, allo stomaco, al colo e al retto.
    E.1.1.1Medical condition in easily understood language
    cancers of the esophagus, stomach, colon, or rectum
    cancro dell'esofago, dello stomaco, del colon e del retto
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10052360
    E.1.2Term Colorectal adenocarcinoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10053548
    E.1.2Term Gastrointestinal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal, pancreatic or colorectal cancer, measured by the ability to administer on-time, full-dose chemotherapy
    valutare l’efficacia di romiplostim per il trattamento della trombocitopenia (TIC) indotta da chemioterapia in pazienti sottoposti a chemioterapia per il trattamento del cancro gastrointestinale, pancreatico o colorettale, in base alla possibilità di somministrare la chemioterapia puntualmente e a pieno dosaggio
    E.2.2Secondary objectives of the trial
    - to compare the treatment effect of romiplostim with that of placebo on the depth of platelet nadir
    - to compare the treatment effect of romiplostim with that of placebo on the time to first platelet response
    - to compare the treatment effect of romiplostim with that of placebo on the incidence of > = grade 2 bleeding events
    - to compare the treatment effect of romiplostim with that of placebo on overall survival
    - to compare the treatment effect of romiplostim with that of placebo on the incidence of platelet transfusions
    -to compare the treatment effect of romiplostim with that of placebo on the proportion of patients achieving platelet response
    -overall safety of romiplostim
    - confrontare l’effetto terapeutico di romiplostim con quello del placebo sulla profondità del nadir della conta piastrinica
    - confrontare l’effetto terapeutico di romiplostim con quello del placebo in termini di tempo alla comparsa della prima risposta piastrinica
    - confrontare l’effetto terapeutico di romiplostim con quello del placebo sull’incidenza dei sanguinamenti > = grado 2
    - confrontare l’effetto di romiplostim con quello del placebo sulla sopravvivenza globale
    - confrontare l’effetto terapeutico di romiplostim con quello del placebo sull’incidenza delle trasfusioni di piastrine
    - confrontare l'effetto terapeutico di romiplostim con quello del placebo sulla percentuale di pazienti che hanno ottenuto una risposta piastrinica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has provided informed consent prior to initiation of any study specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
    2. Males or females > = 18 years of age at signing of the informed consent.
    3. Histologically or cytologically confirmed diagnosis of gastrointestinal, pancreatic or colorectal adenocarcinoma, defined as cancers of the esophagus, stomach, pancreas, colon, or rectum. Tumor stage will not affect eligibility.
    4. Subjects must be receiving 1 of the following regimens: an oxaliplatin-based chemotherapy regimen, containing 5-FU or capecitabine plus oxaliplatin (irinotecan may be added for FOLFIRINOX
    or FOLFOXIRI) on a 14- or 21-day schedule, respectively..
    Note: Use of these regimens are permitted with (1) anti-angiogenic agents (such as bevacizumab) or (2) targeted therapy (such as anti-epidermal growth factor receptor agents). FOLFOXIRI based regimens will not be allowed.
    5. Subjects must have a platelet count < 75 x 109/L on study day 1.
    6. Subjects must be at least 14 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if they received FOLFOX, FOLFIRINOX or FOLFOXIRI, and 21 days removed if they received CAPEOX.
    7. Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.
    8. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
    1. Soggetti che hanno fornito il consenso informato prima dell'inizio di qualsiasi attività/procedura dello studio o consenso informato da pare del legale rappresentante prima che venga avviata qualsiasi attività/procedura legata allo studio, quando il soggetto presenta una qualsiasi condizione per la quale, secondo il parere dello sperimentatore, potrebbe compromettere l'abilità dello stesso nel fornire il consenso informato scritto.
    2. Uomini o donne di età > = 18 anni al momento della firma del consenso informato
    3. Diagnosi confermata istologicamente o citologicamente di adenocarcinoma gastrointestinale, pancreatico o colorettale, definiti come cancro all'esofago, stomaco, pancreas colon o retto. LO stadio del tumore non influenzerà l'eleggibilità.
    4. I soggetti hanno ricevuto uno dei seguenti trattamenti: trattamento chemioterapico a base di oxaliplatino, contenente 5-FU o capecitabina più oxaliplatino (irinotecan può essere aggiunto al trttamento con FOLFIRINOX o FOLFOXIRI) rispettivamente nei giorni 14 o 21 del trattamento.
    Note: L'impiego di questi regimi è consentito in combinazione con (1) agenti antiangiogenici (come bevacizumab) o terapia targhetizzata (come farmaci anti-fattore di crescita epidermico). I regimi a base di FOLFOXIRI non sono ammessi.
    5. I soggetti devono avere una conta piastrinica < 75 x 10e9/L al giorno 1 dello studio
    6. I soggetti devono essere rimossi almeno 14 giorni dall'inizio del ciclo di chemioterapia immediatamente prima del giorno di studio 1 se hanno ricevuto FOLFOX, FOLFIRINOX o FOLFOXIRI, e 21 giorni rimossi se hanno ricevuto CAPEOX.
    7. I soggetti devono ancora sottoporsi ad almeno 3 cicli chemioterapici pianificati rimanenti.
    8. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
    E.4Principal exclusion criteria
    1.Acute lymphoblastic leukemia.
    2.Acute myeloid leukemia.
    3.Any myeloid malignancy.
    4.Myelodysplastic syndrome.
    5.Myeloproliferative disease.
    6.Multiple myeloma.

    *Please, refers to protocol for the full list
    1. Leucemia linfoblastica acuta
    2. Leucemia mieloide acuta
    3. Qualsiasi tipo di malignità mieloide
    4. Sindrome mielodisplastica
    5. Malattia mieloproliferativa
    6. Mieloma multiplo

    *Fare riferimento al protocollo per la lista completa
    E.5 End points
    E.5.1Primary end point(s)
    no thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L
    nessuna modifica indotta da trombocitopenia di qualsiasi agente mielosoppressivo nel secondo e terzo ciclo del regime chemioterapico pianificato nel corso dello studio le modifiche indotte da trombocitopenia comprendono la riduzione della dose per chemioterapia, il ritardo, l'omissione o l'interruzione del trattamento con chemioterapia a causa della conta piastrinica inferiore a 100 x 109 / L
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early.
    L'analisi primaria verrà eseguita alla data di completamento principale. La prima data di completamento è definita come la data in cui l'ultimo soggetto è assegnato o riceve un intervento per la raccolta finale dei dati per la conduzione di un'analisi primaria del primo endpoint, se lo studio si è concluso come previsto nel protocollo o è stato chiuso anticipatamente.
    E.5.2Secondary end point(s)
    • the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period
    • the time to first platelet response, defined by platelet count > = 100 x 109/L in the absence of platelet transfusions during the preceding 7 days
    • the duration-adjusted event rate of > = grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale
    • overall survival
    • platelet transfusion(s) during the treatment period
    • achieving a platelet count = 100 x 109/L at any time after study day 1 to week 4 (ie, 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days
    • adverse events, including treatment-emergent adverse events, fatal adverse events, serious adverse events, and clinically significant changes in laboratory values.
    • anti-romiplostim antibodies and antibodies to thrombopoietin (TPO)
    • myelodysplastic syndromes and secondary malignancies
    - la profondità del nadir della conta piastrinica dall’inizio del primo ciclo chemioterapico durante lo studio fino alla fine del periodo di trattamento - tempo alla comparsa della prima risposta piastrinica, definito da una conta piastrinica > = 100 x 109/L in assenza di trasfusioni di piastrine nei 7 giorni precedenti
    - tasso di eventi aggiustato per durata dei sanguinamenti > = grado 2 valutato in base alla versione 5.0 della scala dei Common Terminology Criteria for Adverse Events (CTCAE)
    - sopravvivenza globale
    - trasfusione/i di piastrine durante il periodo di trattamento
    - Raggiungere una conta piastrinica 100x109/L in qualsiasi momento dopo il giorno 1 fino alla settimana 4 (ossia 7 giorni dopo la terza dose programmata del farmaco sperimentale) e in assenza di trasfusioni di piastrine nei 7 giorni precedenti
    - eventi avversi, inclusi eventi emersi durante il trattamento, eventi avversi fatali, eventi avversi gravi e variazioni clinicamente significative dei valori di laboratorio.
    - anticorpi anti-romiplostim e anticorpi contro la trombopoietina (TPO)
    - sindrome mielodisplastica e neoplasie maligne secondarie
    E.5.2.1Timepoint(s) of evaluation of this end point
    -The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early.
    -When the last subject in the trial completes LTFU at 1 year after the last dose of investigational product, the final database will be locked and unblinded for the final analysis. In the final analysis, the secondary endpoints assessment, and all the exploratory endpoints will be evaluated
    - L'analisi primaria sarà eseguita alla prima data di completamento. La prima data di completamento è intesa come la data in cui l'ultimo soggetto è valutato o riceve un intervento per la raccolta finale dei dati per l'endpoint primario con lo scopo di condurre un'analisi primaria, se lo studio è stato concluso come pianificato nel protocollo o è terminato prima.
    - quando l'ultimo soggetto del trial completa LTFU un anno dopo l'ultima dose di prodotto sperimentale, il database finale verrà bloccato. Nell'analisi finale, la valutazione dell'endpoint secondario e tutti gli endpoint esplorativi verranno valutati
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Brazil
    Canada
    Chile
    Colombia
    Mexico
    Peru
    Russian Federation
    Ukraine
    United States
    Austria
    Bulgaria
    France
    Greece
    Hungary
    Italy
    Poland
    Portugal
    Romania
    Spain
    Argentina
    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
    The end of study date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (i.e. last subject last visit), following any additional parts in the study (eg, LTFU), as applicable. Based on the definition above, the EOS date is the date when the last subject in the trial has completed his/her EOS visit
    La data di fine studio è definita come la data in cui l'ultimo soggetto tra tutti i siti viene valutato o riceve un intervento per la valutazione nello studio ( p.e. ultimo paziente ultima visita), a seguito di qualsiasi parte addizionale dello studio ( LTFU), dove applicabile. In base alla definizione di cui sopra, la data di fine studio è quella in cui l'ultimo soggetto ha completato la sua ultima visita di fine sperimentazione.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 162
    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
    NA
    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 Decision2019-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-20
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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