Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   33728   clinical trials with a EudraCT protocol, of which   5463   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-003823-36
    Sponsor's Protocol Code Number:AS/PALO/002
    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:2012-03-08
    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 number2011-003823-36
    A.3Full title of the trial
    Phase II randomized multicenter study of multiple doses of palonosetron plus aprepitant versus multiple doses of palonosetron alone in preventing chemotherapy-induced nausea and vomiting in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome receiving multiple days chemotherapy
    Studio di fase II randomizzato di dosi multiple di palonosetron in associazione con aprepitant verso dosi multiple di palonosetron nel prevenire la nausea ed il vomito da chemioterapia in pazienti con leucemia mieloide acuta o con sindrome mielodisplasica ad alto rischio trattati con chemioterapia a giorni multipli
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II randomized multicenter study of multiple doses of palonosetron plus aprepitant versus multiple doses of palonosetron alone in preventing chemotherapy-induced nausea and vomiting in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome receiving multiple days chemotherapy
    Studio di fase II randomizzato di dosi multiple di palonosetron in associazione con aprepitant verso dosi multiple di palonosetron nel prevenire la nausea ed il vomito da chemioterapia in pazienti con leucemia mieloide acuta o con sindrome mielodisplasica ad alto rischio trattati con chemioterapia a giorni multipli
    A.3.2Name or abbreviated title of the trial where available
    Palonosetron + Aprepitant versus Palonosetron alone
    Palonosetron + Aprepitant versus Palonosetron solo
    A.4.1Sponsor's protocol code numberAS/PALO/002
    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 SponsorASSOCIAZIONE SALENTINA ANGELA SERRA ONLUS
    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 organisationSC Ematologia - P.O. "Vito Fazzi" - Lecce
    B.5.2Functional name of contact pointTrial Office
    B.5.3 Address:
    B.5.3.1Street AddressP.zza Filippo Muratore, 1
    B.5.3.2Town/ cityLecce
    B.5.3.3Post code73100
    B.5.3.4CountryItaly
    B.5.4Telephone number+ 39 0832 661923
    B.5.5Fax number+ 39 0832 661923
    B.5.6E-mailquinta.ematolecce@libero.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 Yes
    D.2.1.1.1Trade name ALOXI*1FL 250MCG 5ML
    D.2.1.1.2Name of the Marketing Authorisation holderITALFARMACO SpA
    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.3.4Pharmaceutical form 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 INNPALONOSETRON
    D.3.9.1CAS number 135729-56-5
    D.3.9.2Current sponsor codeAloxi
    D.3.9.4EV Substance CodeSUB09593MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.25
    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 Yes
    D.3.11.13.1Other medicinal product typeantiemetico ed antinausea
    D.IMP: 2
    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 EMEND*1CPS 125MG+2CPS 80MG
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME SpA
    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.3.4Pharmaceutical 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 INNAPREPITANT
    D.3.9.1CAS number NA
    D.3.9.4EV Substance CodeSUB20017
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number125
    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 Yes
    D.3.11.13.1Other medicinal product typeAntiemetico ed antinausea
    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
    patients with Acute Myeloid leukemia or high-risk Myelodisplastic syndrome according to IPSS score treated with AML-like multiple days chemotherapy regimen
    pazienti con leucemia mieloide acuta o con sindrome mielodisplasica ad alto rischio trattati con chemioterapia AML-like a giorni multipli
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid leukemia or high-risk Myelodisplastic syndrome according to IPSS score
    Leucemia Mieloide Acuta e Sindromi Mielodisplastiche ad alto rischio secondo l'IPSS score
    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 SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary endpoint is the overall rate of patients achieving 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 o di impiego di medicazioni antiemetiche, durante il periodo dello studio (corrispondente ai giorni di somministrazione di chemioterapia e le 48 ore successive all’ultima somministrazione) nei due bracci di trattamento
    E.2.2Secondary objectives of the trial
    1.Complete Response (single days only) 2.Complete Control (defined as no emetic episode, no need for rescue medication, with a maximum grade of mild nausea); 3.Percentage of patients emesis-free (no emetic episodes); 4.Presence of nausea graded according to Likert scale (none, mild, moderate and severe); 5.Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first); 6.patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS); 7.Safety profile.
    1.Risposta completa dei singoli giorni di terapia 2.Controllo completo (definito come risposta completa e non più di nausea lieve) 3.Percentuali di pazienti liberi da emesi (nessun episodio emetico) 4.Percentuale di nausea secondo la scala Likert (no, lieve, moderata e severa) 5.valutare il tempo al fallimento del trattamento (definito come la comparsa del primo episodio di vomito o il primo impiego di medicazioni antiemetiche); 6.valutare il livello di soddisfazione dei pazienti alla terapia antiemetica, misurata tramite una scala visiva analogica (visual analogue scale) 7.profilo di sicurezza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Diagnosis of Acute Myeloid Leukaemia or High-risk MDS according to IPSS •Patient eligible for AML-like induction therapy •Candidate for multiple–days chemotherapy (minimum 3 days) •Age > 18 years •ECOG 0-2 •Not pregnant or nursing •Must be able to complete the patient’s diary •Provide written informed consent
    - Diagnosi di AML o HR-MDS - Età maggiore uguale a 18 anni - Pazienti candidati a trattamento chemioterapico a più giorni consecutivi (minimo 3, massimo 7) - ECOG Performance Status 0-2 - 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
    •AML or HR-MDS therapy-related •Active infection requiring intravenous antibiotics •Prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for ≥ 5 years •Unacceptable hepatic function (>2 times the upper limit of normal for liver transaminases) and renal function (creatinine >1.5 times the upper limit of normal) unless disease-related •Myocardial infarction within the past 6 months •Psychiatric or CNS disorders interfering with ability to comply with study protocol •Known hypersensitivity to 5-HT3 antagonists and their components •CSF involvement •Pre-existing nausea or vomiting - treatment with experimental drug within the last month - Uncontrolled diabetes
    - AML o MDS therapy-related - infezione attiva richiedente terapia antibiotica IV - precedenti neoplasie in altre sedi ad eccezione dei tumori cutanei non melanoma trattati chirurgicamente, tumore della prostata, tumore superficiale della cervice uterina, o altri tumori per i quali il paziente risulta libero da malattia da almeno 5 anni - Funzionalità epatica e/o renale alterata (&gt; 2 volte il limite superiore di normalità) a meno che non correlato alla malattia - Malattie psichiatriche o del SNC che interferiscono con la capacità di essere aderente allo studio - Meningosi leucemica - Trattamento con farmaci sperimentali nei 30 giorni antecedenti il trattamento con palonosetron - Infarto del miocardio negli ultimi 6 mesi - Nota ipersensibilità ai 5-HT3 antagonisti - Diabete mellito non controllato - nausea e vomito pre-esistenti all'ingresso nello studio
    E.5 End points
    E.5.1Primary end point(s)
    the overall rate of patients achieving 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 o di impiego di medicazioni antiemetiche, durante il periodo dello studio (corrispondente ai giorni di somministrazione di chemioterapia e le 48 ore successive all’ultima somministrazione) nei due bracci di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be under evaluation from Day 1 (the first day of chemotherapy) until 48 hrs after the last dose of chemotherapy. Patients will be evaluated for overall phase (from 0 hour until 48 hrs after the last dose of chemotherapy) and separately on single days.
    I pazienti saranno valutati dal giorno 1 (il primo giorno di chemioterapia) fino a 48 ore dall'ultima dose di chemioterapia. I pazienti saranno valutati per l'Overall phase (dall'ora 0 fino a 48 ore dall'ultima dose di chemioterapia) eseparatamente ogni singolo giorno.
    E.5.2Secondary end point(s)
    1.Complete Response (single days only) 2.Complete Control (defined as no emetic episode, no need for rescue medication, with a maximum grade of mild nausea); 3.Percentage of patients emesis-free (no emetic episodes); 4.Presence of nausea graded according to Likert scale (none, mild, moderate and severe); 5.Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first); 6.patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS); 7.Safety profile.
    1.Risposta completa dei singoli giorni di terapia 2.Controllo completo (definito come risposta completa e non più di nausea lieve) 3.Percentuali di pazienti liberi da emesi (nessun episodio emetico) 4.Percentuale di nausea secondo la scala Likert (no, lieve, moderata e severa) 5.valutare il tempo al fallimento del trattamento (definito come la comparsa del primo episodio di vomito o il primo impiego di medicazioni antiemetiche); 6.valutare il livello di soddisfazione dei pazienti alla terapia antiemetica, misurata tramite una scala visiva analogica (visual analogue scale) 7.profilo di sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be under evaluation from Day 1 (the first day of chemotherapy) until 48 hrs after the last dose of chemotherapy. Patients will be evaluated for overall phase (from 0 hour until 48 hrs after the last dose of chemotherapy) and separately on single days.
    I pazienti saranno valutati dal giorno 1 (il primo giorno di chemioterapia) fino a 48 ore dall'ultima dose di chemioterapia. I pazienti saranno valutati per l'Overall phase (dall'ora 0 fino a 48 ore dall'ultima dose di chemioterapia) eseparatamente ogni singolo giorno.
    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 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 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) 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 concerned18
    E.8.5The trial involves multiple Member States No
    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 No
    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
    The study will be close when the 134 patients planned will be enrolled into study
    Lo studio sarà concluso quando saranno arruolati i 134 pazienti previsti
    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
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state134
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-Thu Dec 13 03:45:32 GMT 2018 | 30 Churchill Place, Canary Wharf, London E14 5EU
    Legal notice
    EMA HMA