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    Summary
    EudraCT Number:2015-003316-20
    Sponsor's Protocol Code Number:GIM15-NEPA
    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:2021-09-06
    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 number2015-003316-20
    A.3Full title of the trial
    One day antiemetic prophylaxis of NEPA (netupitant plus palonosetron) and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients receiving a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen)
    Singola somministrazione di NEPA (netupitant plus palonosetron) più desametasone, per prevenire la nausea e il vomito da chemioterapia (CINV) in pazienti con tumore della mammella che ricevono multipli cicli di doxorubicina o epirubicina con ciclofosfamide (regime a base di AC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    One day antiemetic prophylaxis of NEPA (netupitant plus palonosetron) and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients receiving a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen)
    Singola somministrazione di NEPA (netupitant plus palonosetron) più desametasone, per prevenire la nausea e il vomito da chemioterapia (CINV) in pazienti con tumore della mammella che ricevono multipli cicli di doxorubicina o epirubicina con ciclofosfamide (regime a base di AC)
    A.3.2Name or abbreviated title of the trial where available
    NEPA to prevent chemotherapy induced nausea and vomiting in patients with breast cancer
    NEPA per prevenire la nausea e il vomito da chemioterapia (CINV) in pazienti con tumore della mammel
    A.4.1Sponsor's protocol code numberGIM15-NEPA
    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 SponsorCONSORZIO ONCOTECH
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportItalfarmaco S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo - Traversa Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailhelpdesk.nepa@oncotech.org
    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 Akynzeo
    D.2.1.1.2Name of the Marketing Authorisation holderHelsinn Birex Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAkynzeo
    D.3.2Product code NEPA
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNetupitant/palonosetron
    D.3.9.2Current sponsor codeNEPA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 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
    Chemotherapy-Induced Nausea and Vomiting (CINV) in breast cancer patients receiving a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen)
    Nausea e vomito indotti da chemioterapia (CINV) in pazienti con tumore della mammella che ricevono cicli multipli di doxorubicina o epirubicina con ciclofosfamide (regime a base di AC)
    E.1.1.1Medical condition in easily understood language
    Chemotherapy-Induced Nausea and Vomiting in breast cancer patients
    Nausea e vomito indotti da chemioterapia in pazienti con tumore della mammella
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008443
    E.1.2Term Chemotherapy antiemetic prophylaxsis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10054133
    E.1.2Term Prophylaxis of nausea and vomiting
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008448
    E.1.2Term Chemotherapy induced emesis prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10049091
    E.1.2Term Chemotherapy antiemetic prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008449
    E.1.2Term Chemotherapy inducted emesis prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036899
    E.1.2Term Prophylaxis against chemotherapy induced vomiting
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 if the activity of one day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles)
    Valutare se l’attività della singola dose di NEPA più desametasone per la prevenzione di nausea e vomito indotti da chemioterapia in pazienti con tumore della mammella che hanno effettuato una chemioterapia adiuvante a base di AC, è mantenuta durante l’intero trattamento chemioterapico (massimo 4 cicli)
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    – Women >= 18 years old.
    – Histologically or cytologically confirmed diagnosis of breast cancer.
    – Na¿f patients.
    – Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclofosfamide (AC-based regimen).
    – ECOG Performance Status 0-2.
    – Body Mass Index (BMI) >= 18.5.
    – Written informed consent.
    – If women of childbearing potential age: reliable contraceptive measures must be used.
    – Normal hepatic function (<= 2 times the upper limit of normal for liver transaminases) and renal function (creatinine < 1.5 times the upper limit of normal).
    – Ability and willingness of the patient to complete the diary.
    – Donne con età >= 18 anni.
    – Diagnosi istologicamente/citologicamente confermata di tumore della mammella.
    – Paziente naïf.
    – Paziente candidata a ricevere chemioterapia adiuvante a base di antracicline (doxorubicina o epirubicina) con ciclofosfamide (Regime a base di AC).
    – ECOG Performance Status 0-2.
    – Indice di massa corporea (BMI) >= 18.5.
    – Consenso Informato Scritto.
    – In caso di donna in età fertile: uso di adeguati metodi contraccettivi.
    – Funzionalità renale ed epatica nella norma (transaminasi <= 2 volte il valore massimo; creatinina < 1,5 volte il valore massimo).
    – Capacità e volontà da parte del paziente di compilare il diario.
    E.4Principal exclusion criteria
    – Advanced/metastatic breast cancer.
    – Patients already submitted to non-AC-based chemotherapy.
    – Treatment with investigational medications within 30 days before NEPA.
    – Myocardial infarction within the last 6 months.
    – Documented or known hypersensitivity to 5HT3RA or NK1RA and excipients.
    – Uncontrolled diabetes mellitus.
    – Nausea and vomiting at baseline.
    – Chronic use of other antiemetic agent(s).
    – Patient’s inability to take oral medication.
    – Gastrointestinal obstruction or active peptic ulcer.
    – Pregnancy or breastfeeding
    – Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for >= 5 years.
    – Psychiatric or CNS disorders interfering with ability to comply with study protocol.
    – Pazienti con tumore della mammella avanzato o metastatico
    – Pazienti già sottoposte a chemioterapia diversa da regimi a base di AC.
    – Trattamento con farmaci sperimentali nei 30 giorni antecedenti il trattamento con NEPA.
    – Infarto del miocardio negli ultimi 6 mesi.
    – Ipersensibilità nota o documentata ai farmaci 5-HT3 antagonisti o agli NK1 antagonisti.
    – Diabete mellito non controllato.
    – Nausea e vomito al basale.
    – Uso cronico di altri agenti antiemetici.
    – Incapacità della paziente di assumere farmaci per via orale.
    – Ostruzione gastrointestinale o ulcera peptica attiva.
    – Gravidanza o allattamento.
    – Neoplasie precedenti in altre sedi, ad eccezione del cancro della pelle non-melanoma trattato chirurgicamente, cancro superficiale della cervice, o altro tumore per il quale il paziente è risultato libero dalla malattia per un periodo maggiore o uguale a 5 anni.
    – Disturbi psichiatrici o del sistema nervoso centrale che interferiscono con la capacità di rispettare il protocollo di studio.
    E.5 End points
    E.5.1Primary end point(s)
    The rate of patients achieving and maintaining a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase
    Valutare il numero di pazienti che ottengono una risposta completa, definita come assenza di episodi di vomito e d’impiego di medicazioni antiemetiche di salvataggio durante i quattro cicli di chemioterapia a base di AC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles.
    durante i quattro cicli di chemioterapia a base di AC considerando per ogni ciclo l’intero periodo di rischio di CINV (fase overall, corrispondente ai 5 giorni successivi alla somministrazione della chemioterapia).
    E.5.2Secondary end point(s)
    • rate of complete response (no vomiting and no use of rescue medication)
    • rate of complete control (defined as complete response with a maximum grade of mild nausea)
    • rate of emesis-free patients
    • severity of nausea graded according to Likert
    • patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)
    • Safety profile.
    • Risposta completa, definita come assenza di episodi di vomito e d’impiego di terapia di salvataggio.
    • Controllo completo, definito come risposta completa e non più di nausea lieve.
    • Percentuale di pazienti libere da emesi (nessun episodio emetico).
    • Percentuale di nausea secondo la scala Likert (nessuna, lieve, moderata e severa).
    • Livello di soddisfazione globale delle pazienti alla terapia antiemetica, misurata tramite una scala visiva analogica (VAS).
    • Profilo di sicurezza secondo i Common Terminology Criteria for Adverse Events (CTCAE) Versione 4.3.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the Acute Phase (0-24 hours after chemotherapy), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle and separately on single days of all chemotherapy cycles, up to 4 cycles
    Durante la fase acuta (giorno della somministrazione della chemioterapia), fase ritardata (dalla 25 alla 120 ora post chemioterapia, 2-5 giorni) e nella fase overall (5 giorni, 120 ore, successivi alla somministrazione della chemioterapia) di tutti i cicli di chemioterapia a cui le pazienti saranno sottoposte, per un massimo di 4 cicli
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned41
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA41
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 years0
    E.8.9.1In the Member State concerned months18
    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 months18
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    Not applicable
    Non applicabile
    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 Decision2016-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
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