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    Summary
    EudraCT Number:2011-004687-30
    Sponsor's Protocol Code Number:MM-398-07-03-01
    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:2012-06-28
    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 number2011-004687-30
    A.3Full title of the trial
    NAPOLI 1: A Randomized, Open Label Phase 3 Study of MM-398 versus 5- Fluorouracil and Leucovorin in Patients with Metastatic Pancreatic Cancer.
    NAPOLI 1: Studio randomizzato, in aperto, di fase 3, di confronto tra MM-398 e 5-Fluorouracile con Leucovorina nei pazienti con carcinoma pancreatico metastatico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of MM-398 compared with 5-fluorouracil abd Leucovorin in Patients with advanced pancreatic cancer.
    Uno studio su MM-398 in confronto a 5-fluorouracile e leucovorina in pazienti con carcinoma pancreatico metastatico.
    A.3.2Name or abbreviated title of the trial where available
    NAPOLI 1
    NAPOLI 1
    A.4.1Sponsor's protocol code numberMM-398-07-03-01
    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 SponsorMERRIMACK PHARMACEUTICALS
    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 supportMerrimack Pharmaceuticals
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerrimack Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMerrimack MM398 Clinical Trial Mger
    B.5.3 Address:
    B.5.3.1Street AddressOne Kendall Square, Suite B7201
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 617 441-1000
    B.5.5Fax number001 617 812-7776
    B.5.6E-mailclinical@merrimackpharma.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 nameNA
    D.3.2Product code MM-398
    D.3.4Pharmaceutical form Concentrate 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 INNIRINOTECAN HYDROCHLORIDE
    D.3.9.1CAS number 136572-09-3
    D.3.9.2Current sponsor codeMM-398
    D.3.9.3Other descriptive nameIrinotcan nanoliposomale
    D.3.9.4EV Substance CodeSUB02772MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Fluorouracil Injection
    D.2.1.1.2Name of the Marketing Authorisation holderHospira Australia Pty
    D.2.1.2Country which granted the Marketing AuthorisationAustralia
    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.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNFLUOROURACIL
    D.3.9.1CAS number 51-21-8
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Leucovorin Calcium Injection
    D.2.1.1.2Name of the Marketing Authorisation holderHospira Australia Pty
    D.2.1.2Country which granted the Marketing AuthorisationAustralia
    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.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNFOLINIC ACID
    D.3.9.1CAS number 58-05-9
    D.3.9.4EV Substance CodeSUB13910MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic pancreatic cancer.
    Carcinoma pancreatico metastatico.
    E.1.1.1Medical condition in easily understood language
    Cancer of the pancreas that has spread to other areas.
    Carcinoma del pancreas diffuso in altre aree del corpo.
    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 LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic 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 compare overall survival following treatment with MM-398 versus 5-
    fluorouracil and leucovorin in patients with metastatic pancreatic cancer
    that have progressed on gemcitabine based therapy.
    Confrontare la sopravvivenza complessiva a seguito del trattamento
    con MM-398 rispetto a 5-fluorouracile e leucovorina nei pazienti
    affetti da carcinoma pancreatico metastatico che hanno presentato
    una progressione durante il trattamento basato su gemcitabina.
    E.2.2Secondary objectives of the trial
    • To compare the following time-to-event efficacy endpoints between the two treatment arms:
    Progression-free survival (PFS)
    Time to treatment failure (TTF)
    • To compare the Objective Response Rate (ORR) between the two treatment arms
    • To compare the tumor marker response of CA 19-9 between the two treatment arms
    • To compare the Clinical Benefit Response (CBR) rate between the two treatment arms
    • To assess patient-reported outcomes (PROs) between the two
    treatment arms using the European Organization for Research and
    Treatment of Cancer (EORTC) quality-of-life core questionnaire(EORTC-QLQ-C30)
    • To compare the safety and adverse event profile between the two treatment arms
    • To determine the pharmacokinetic properties of MM-398 in this population
    Gli obiettivi secondari dello studio sono:
    •Confrontare i seguenti endpoint di efficacia relativi al tempo fino al verificarsi di un evento tra i due bracci di trattamento:
    •Sopravvivenza libera da progressione
    (Progression-Free Survival,PFS)
    •Tempo fino al mancato successo del trattamento
    (Time to Treatment Failure,TTF)
    •Confrontare il tasso di risposta obiettiva (Objective Response
    Rate,ORR) tra i due bracci di trattamento
    •Confrontare la risposta del marcatore tumorale di CA 19-9 tra
    i due bracci di trattamento
    •Confrontare il tasso di risposta con beneficio clinico (Clinical
    Benefit Response,CBR) tra i due bracci di trattamento
    •Valutare gli esiti riportati dal paziente (Patient-Reported
    Outcomes,PROs) tra i due bracci di trattamento utilizzando il
    questionario di base sulla qualità della vita (EORTC-QLQC30)
    dell’Organizzazione europea per la ricerca e i
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENOMIC:
    Vers:1
    Date:2011/11/03
    Title:Translational Research Companion Protocol for NAPOLI-1: A Randomized, Open Label Phase III Study of MM-398 versus 5- Fluorouracil and Leucovorin in Patients with Metastatic Pancreatic Cancer.
    Objectives:The objective of this translational research protocol is to explore the biomarkers associated with toxicity and efficacy following treatment with MM-398.
    FARMACOGENOMICA:
    Vers:1
    Data:2011/11/03
    Titolo:Protocollo di accompagnamento alla ricerca traslazionale per lo studio NAPOLI-1: Studio randomizzato, in aperto, di fase III condotto su MM-398 rispetto a 5-fluorouracile e leucovorina in pazienti affetti da
    tumore del pancreas con metastasi.
    Obiettivi:L’obiettivo di questo protocollo di ricerca traslazionale è quello di esaminare i biomarcatori associati a tossicità ed efficacia dopo il trattamento con MM-398.
    E.3Principal inclusion criteria
    • Histologically or cytologically confirmed adenocarcinoma of
    exocrine pancreas
    • Documented metastatic disease; disease status may be measurable or
    non-measurable as defined by RECIST v1.1 guidelines
    • Documented disease progression after prior gemcitabine or
    gemcitabine containing therapy, in locally advanced or metastatic
    setting. Examples of permitted therapies include, but are not limited to:
    o Single agent gemcitabine
    o Any one gemcitabine-based regimen, with or without
    maintenance gemcitabine
    o Single agent gemcitabine to which a platinum agent, a
    fluoropyrimidine, or erlotinib was subsequently added
    o Gemcitabine administered in the adjuvant setting if disease
    recurrence occurred within 6 months of completing the
    adjuvant therapy.
    (for complete list see the protocol).
    • Adenocarcinoma del pancreas esocrino con conferma istologica o citologica
    • Patologia metastatica documentata; lo stato della patologia potrà essere misurabile o non misurabile, secondo la definizione fornita nelle linee guida RECIST v1.1
    • Progressione della malattia documentata dopo precedente
    trattamento con gemcitabina o contenente gemcitabina, in contesto di carcinoma avanzato localizzato o metastatico. Esempi di trattamenti consentiti includono, in modo non limitativo:
    o Gemcitabina come agente unico
    o Qualsiasi regime a base di gemcitabina, con o senza
    gemcitabina di mantenimento
    o Gemcitabina come agente unico al quale sia stato
    aggiunto successivamente un agente platino, una
    fluoropirimidina o erlotinib
    o Gemcitabina somministrata in contesto di terapia
    adiuvante se la recidiva della patologia si è presentata
    entro 6 mesi dal completamento della terapia adiuvante.
    (per l'elenco completo si veda il protocollo).
    E.4Principal exclusion criteria
    • Prior irinotecan treatment
    • Active CNS metastases (indicated by clinical symptoms, cerebral
    edema, steroid requirement, or progressive disease)
    • Clinically significant gastrointestinal disorder including hepatic
    disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
    • History of any second malignancy in the last 5 years; subjects with
    prior history of in-situ cancer or basal or squamous cell skin cancer are
    eligible. Subjects with other malignancies are eligible if they have been
    continuously disease free for at least 5 years.
    • Major surgery or radiotherapy within 4 weeks of enrollment
    • Severe arterial thromboembolic events (myocardial infarction,
    unstable angina pectoris, stroke) less than 6 months before inclusion.
    Precedente trattamento con irinotecan
    • Metastasi attive del sistema nervoso centrale (CNS) (indicate da
    sintomi clinici, edema cerebrale, necessità di trattamento
    steroideo o progressione della malattia)
    • Disturbi gastrointestinali clinicamente significativi, tra i quali
    disturbi epatici, sanguinamento, infiammazione, occlusione o
    diarrea &gt; grado 1
    • Anamnesi di seconda malignità negli ultimi 5 anni; sono idonei i
    soggetti con precedente anamnesi di cancro in-situ o basale o
    cancro della pelle a cellule squamose. I soggetti con altre
    malignità sono idonei se esenti da malattia per almeno 5 anni
    ininterrottamente.
    • Intervento chirurgico o radioterapia significativi entro 4 settimane
    dall’arruolamento
    • Eventi tromboembolici arteriosi gravi (infarto miocardico, angina
    pectoris instabile, ictus) a meno di 6 mesi dall’inclusione
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival.
    Sopravvivenza globale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The analysis for primary endpoint will take place once at least 220 death
    events have occurred.
    L'analisi dell'endpoint primario sarà effettuata una volta che si saranno verificati almeno 220 casi di decesso.
    E.5.2Secondary end point(s)
    Progression Free Survival
    Time to treatment failure
    Objective Response Rate
    Clinical Benefit Response
    Tumor Marker Response
    Patient Reported Outcome
    Sopravvivenza libera da progressione.
    Tempo al fallimento del trattamento
    Velocità di risposta oggettiva
    Beneficio della risposta clinica
    Marcatore della risposta tumorale
    Esito riferito dal paziente
    E.5.2.1Timepoint(s) of evaluation of this end point
    On-going
    in corso di studio.
    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 No
    E.6.10Pharmacogenetic No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Argentina
    Australia
    Brazil
    Canada
    India
    Korea, Republic of
    Russian Federation
    South Africa
    Taiwan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 270
    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)
    as per protocol
    Come da protocollo
    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 Decision2012-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-06
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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
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