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    Summary
    EudraCT Number:2013-003176-12
    Sponsor's Protocol Code Number:A-93-52030-279
    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:2014-07-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-003176-12
    A.3Full title of the trial
    A PHASE II, MULTICENTRE, RANDOMIZED CONTROLLED STUDY EVALUATING THE QUALITY OF LIFE IN PATIENTS WITH INOPERABLE MALIGNANT BOWEL OBSTRUCTION TREATED WITH LANREOTIDE AUTOGEL 120 MG IN COMBINATION WITH STANDARD CARE VS. STANDARD CARE ALONE (QOL IN IMBO STUDY)”.
    Studio controllato di fase II, multicentrico, randomizzato, di valutazione della qualità di vita in pazienti con occlusione intestinale maligna inoperabile trattati con Lanreotide Autogel 120 mg in associazione alla terapia standard verso la sola terapia standard (STUDIO QOL IN IMBO).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE II, MULTICENTRE, RANDOMIZED CONTROLLED STUDY EVALUATING THE QUALITY OF LIFE IN PATIENTS WITH INOPERABLE MALIGNANT BOWEL OBSTRUCTION TREATED WITH LANREOTIDE AUTOGEL 120 MG IN COMBINATION WITH STANDARD CARE VS. STANDARD CARE ALONE
    STUDIO DI FASE II, MULTICENTRICO, RANDOMIZZATO IN APERTO E CONTROLLATO PER LA VALUTAZIONE DELLA QUALITA’ DI VITA IN PAZIENTI CHE SOFFRONO DI OSTRUZIONE INTESTINALE MALIGNA NON OPERABILE, TRATTATI CON LANREOTIDE AUTOGEL 120 MG IN ASSOCIAZIONE CON LA TERAPIA STANDARD VERSO PAZIENTI TRATTATI CON SOLO TERAPIA STANDARD
    A.3.2Name or abbreviated title of the trial where available
    QOL in IMBO STUDY
    A.4.1Sponsor's protocol code numberA-93-52030-279
    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 SponsorIPSEN S.p.A
    B.1.3.4CountryItaly
    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 supportIPSEN S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIPSEN S.p.A
    B.5.2Functional name of contact pointDirezione Medica
    B.5.3 Address:
    B.5.3.1Street AddressVia A. Figino 16
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number00390239 22 41
    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 Ipstyl 120 mg
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN S.p.A
    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 nameIPSTYL
    D.3.2Product code 52030
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    Inoperable malignant bowel obstruction
    Occlusione intestinale maligna inoperable
    E.1.1.1Medical condition in easily understood language
    Inoperable malignant bowel obstruction
    Occlusione intestinale maligna inoperable
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10061974
    E.1.2Term Gastrointestinal obstruction
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 impact on Quality of Life (Edmonton Symptom Assessment System, ESAS total score) of LAN ATG 120 mg in combination with standard care, in comparison to the standard care alone.
    Valutare l’impatto sulla Qualità della Vita (attraverso l’Edmonton Symptom Assessment System, ESAS punteggio totale) di Lanreotide Autogel (LAN ATG) 120 mg in associazione alla terapia standard, rispetto alla sola terapia standard.
    E.2.2Secondary objectives of the trial
    1) To evaluate the impact of LAN ATG 120 mg on each ESAS item and total score;
    2) To assess General activity (Karnofsky performance status) and Abdominal Pain (Visual analogue scale);
    3) To assess the efficacy of LAN ATG 120 mg for the relief of vomiting in patients without nasogastric tube (NGT);
    4) To assess the efficacy of LAN ATG 120 mg on NGT secretion volumes or to remove NGT without recurrence of vomiting in patients with a nasogastric tube;
    5) Passage of stools (Yes/No);
    6) Descriptive analysis of optional ESAS item 10;
    7) To assess the efficacy in reducing concomitant medications/ analgesics intake.
    1) Valutare l’impatto di LAN ATG 120 mg su ogni voce del questionario ESAS e sul punteggio totale;
    2) Valutare lo stato di salute generale (attraverso l’indice di Karnofsky) ed il dolore addominale (attraverso la scala VAS-scala analogico visiva);
    3) Valutare l’efficacia di LAN ATG 120 mg nell’alleviare il vomito in pazienti senza sondino nasogastrico;
    4) Valutare, in pazienti con sondino nasogastrico, l’efficacia di LAN ATG 120 mg sulla riduzione del volume del secreto raccolto attraverso il sondino nasogastrico, o sulla rimozione del sondino senza ripresa di vomito;
    5) Passaggio delle feci (Si/No);
    6) Analisi descrittiva della voce 10 opzionale del questionario ESAS;
    7) Valutare l’efficacia nel ridurre l’assunzione di farmaci concomitanti ed analgesici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects must demonstrate willingness to participate in the study and to be compliant with any protocol procedure.
    2) Provision of written informed consent prior to any study related procedure.
    3) Male or female aged ≥ 18 years at the time of enrolment.
    4) Diagnosis of an inoperable malignant bowel obstruction, confirmed by appropriate imaging report.
    5) In case of peritoneal carcinomatosis, diagnostic confirmation by CT or MRI scan;
    6) Confirmed as inoperable after medical advice;
    7) Patient with a nasogastric tube or presenting with 3 or more episodes of vomiting every day in the last consecutive 48 hours;
    8) Patient life expectancy must be more than 14 days.
    1) Il soggetto deve essere disponibile a partecipare allo studio e “compliante” con tutte le procedure dello studio;
    2) Il soggetto deve rilasciare il consenso informato per scritto, firmato prima di ogni procedura prevista dallo studio;
    3) Il soggetto può essere uomo o donna, con età ≥ 18 anni al momento dell’arruolamento;
    4) Il soggetti deve avere una diagnosi di occlusione intestinale di origine maligna inoperabile confermata da un appropriato esame strumentale di “imaging”;
    5) In caso di carcinosi peritoneale, la diagnosi deve essere confermata da TAC o risonanza magnetica;
    6) La non operabilità dell’occlusione intestinale di origine maligna deve essere confermata dal giudizio di un clinico;
    7) Il soggetto può avere il sondino nasogastrico o presentare 3 o più episodi di vomito al giorno, nelle ultime 48 ore consecutive;
    8) Il soggetto deve avere una aspettativa di vita superiore a 14 giorni.
    E.4Principal exclusion criteria
    1) Operable obstruction or any subobstruction;
    2) Bowel obstruction due to a non-malignant cause; (hypokaliaemia, drug side-effects, renal insufficiency, etc)
    3) Signs of bowel perforation;
    4) Prior treatment with somatostatin or any analogue within the previous 60 days;
    5) A known hypersensitivity to any of the study treatments or related compounds.
    6) Is likely to require treatment during the study with somatostatin or any analogue other than the study treatment.
    7) Is at risk of pregnancy or lactation, or is likely to father a child during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral or double barrier contraception. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
    8) Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
    9) Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
    1) Il soggetto con occlusione operabile o sub-occlusione;
    2) Il soggetto con occlusione intestinale di origine non maligna (ipocalcemia, effetti collaterali all’assunzione di farmaci, insufficienza renale, etc);
    3) Il soggetto con segni di perforazione intestinale;
    4) Il soggetto che precedente è stato trattato con somatostatina o con qualsiasi suo analogo, entro i 60 giorni precedenti l’arruolamento;
    5) Il soggetto con ipersensibilità nota a uno dei trattamenti in studio o ad un componente correlato;
    6) Il soggetto con la probabilità di ricevere un trattamento con somatostatina o con un suo analogo differente dal farmaco in studio, durante lo studio stesso.
    7) Rischio di gravidanza, allattamento o probabilità di concepire un figlio durante lo studio. Le donne potenzialmente fertili devono fornire un test di gravidanza negativo all’inizio dello studio e devono utilizzare contraccettivi orali o a doppia barriera. La potenziale infertilità è definita come un periodo di menopausa di almeno un anno, sterilizzazione chirurgica o isterectomia da almeno tre mesi prima dell’inizio dello studio;
    8) Ogni condizione mentale che rende il soggetto incapace di comprendere la natura, lo scopo e le possibili conseguenze dello studio, e/o l’evidenza di un atteggiamento non collaborativo da parte del soggetto;
    9) Anomalie alla visita basale, qualsiasi altra condizione clinica o di laboratorio che, a giudizio dello sperimentatore, potrebbero compromettere la sicurezza del soggetto o ridurre la probabilità di ottenere dati soddisfacenti necessari per il raggiungimento degli obiettivi dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison between the mean AUC of ESAS Total Scores collected for the first 7 days in patients with Standard care + 1 injection of LAN ATG 120 mg (Group A) and the corresponding mean AUC in patients with standard care alone (Group B).
    ESAS total score is the sum of nine common symptoms affecting patients with cancer in their terminal phase of life. It consists of nine 0–10 numerical scales: pain, activity, nausea, depression, anxiety, drowsiness, appetite, sense of well-being and shortness of breath. There is an optional tenth scale based on a symptom, which can be added by the patient. Analysis of the primary endpoint will be performed on the first defined 9 items total score.
    ESAS questionnaire will be assessed by the patient or filled in by the nurse/caregiver in case of patient’s physical inability.
    Confronto tra l’AUC media dei punteggi totali ESAS raccolti nei primi sette giorni dai pazienti trattati con terapia standard + 1 iniezione di LAN ATG 120 mg (Gruppo A) e l’analoga AUC media dei pazienti trattati con la sola terapia standard (Gruppo B)
    Il punteggio totale del questionario ESAS è dato dalla somma dei nove sintomi più comuni che affliggono i pazienti con tumore in fase terminale. L’ESAS consiste in nove scale numeriche 0-10: dolore, stanchezza, nausea, depressione, ansia, sonnolenza, disappetenza, malessere, difficoltà a respirare.
    Il questionario comprende anche una decima scala opzionale basata su un sintomo che può essere aggiunto dal paziente.
    L’analisi dell’endpoint primario verrà effettuata sul punteggio totale delle prime nove voci.
    Il questionario ESAS verrà compilato dal paziente o, in caso di impossibilità fisica del paziente, dall’infermiere/a o dall’assistente sanitario.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For both treatment groups ("A" standard therapy + 1 injection of 120 mg AG LAN and "B" standard therapy only) time point of the primary endpoint corresponds to the first 7 days after administration of the treatment.
    Per entrambi i gruppi di trattamento (“A” terapia standard + 1 iniezione di LAN AG 120 mg e “B” terapia standard solamente) il tempo di rilevazione dell’endpoint primario corrisponde ai primi 7 giorni dopo la somministrazione del trattamento stesso.
    E.5.2Secondary end point(s)
    - Secondary Efficacy Endpoints and Evaluations:
    1) Comparison of single ESAS items symptom score and total score at Day 1,2,3,4,5,6 and 7, Day 14, Day 28, between Group A and Group B;
    2) Changes in performing General activity (Karnofsky performance status) at Day 7, Day 14 and Day 28 compared to baseline and comparison between Group A and Group B;
    3) Changes in daily intensity of Abdominal Pain (Visual analogue scale) and comparison between Group A and Group B;
    4) Comparison of number of patients experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any time point between the D1 and D7,14,28, between Group A and Group B, in patients without nasogastric tube (NGT);
    5) Comparison of number of patients in whom the NGT has been removed during at least 3 consecutive days at any time point, between the D1 and D7, 14, 28, without vomiting recurrence, between Group A and Group B;
    6) In patients with a NGT, changes in daily NGT secretion volume and comparison between Group A and Group B;
    7) Comparison of number of daily vomiting episodes and number of days without vomiting, between Group A and Group B;
    8) Passage of stools (Yes/No) daily assessment and comparison between Group A and Group B;
    9) Descriptive analysis of optional ESAS item 10;
    10) Standard care and concomitant medications will be recorded and analysed. In particular changes in analgesic intake.
    1) Confronto tra i punteggi del Gruppo A e del Gruppo B di ogni singola voce dell’ESAS e del punteggio totale ai giorni 1, 2, 3, 4, 5, 6, 7, 14, 28.
    2) Andamento dello stato di salute generale (indice di Karnofsky) al giorno 7, 14 e 28 rispetto al basale e confronto tra il Gruppo A ed il Gruppo B;
    3) Variazioni nell’intensità giornaliera del dolore addominale (scala VAS) e confronto tra il Gruppo A ed il Gruppo B;
    4) Confronto, tra il Gruppo A ed il Gruppo B del numero di pazienti, senza sondino nasogastrico, che hanno avuto un numero di episodi di vomito al giorno ≤ 2 per almeno tre giorni consecutivi in qualunque intervallo di tempo tra i giorni 1 ed i giorni 7, 14, 28.
    5) Confronto tra il Gruppo A ed il Gruppo B del numero di pazienti nei quali il sondino nasogastrico è stato rimosso per almeno 3 giorni consecutivi e senza ripresa di vomito in qualunque momento nel periodo compreso tra il giorno 1 ed i giorni 7, 14 e 28.
    6) Confronto tra il Gruppo A ed il Gruppo B della variazione giornaliera del volume delle secrezioni nei pazienti con sondino nasogastrico.
    7) Confronto tra Gruppo A e Gruppo B del il numero di episodi di vomito giornalieri ed del numero di giorni senza vomito,;
    8) Confronto tra Gruppo A e Gruppo B della valutazione giornaliera del passaggio delle feci (Si/No),
    9) Analisi descrittiva della decima voce opzionale del questionario ESAS;
    10) Verranno registrate ed analizzate le terapie standard ed i farmaci concomitanti. In particolare verranno registrate le variazioni nell’assunzione di analgesici.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending on the endpoint detection times are detailed in the description of the endpoint in the same section. 5.2
    A seconda degli end point i tempi di rilevazione sono dettagliati nella descrizione stessa dell'endpoint in sez. 5.2
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Impact of the treatment on Quality of Life
    Impatto del trattamento sulla qualità della vita
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia standard
    standard terapy
    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 concerned12
    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
    2 years
    2 anni
    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
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state84
    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)
    Patients will continue the best treatment decided by the doctor based on the standard therapy used for clinical practice at each center
    I pazienti continueranno il miglior trattamento deciso dal medico sulla base della terapia standard utilizzata per pratica clinica presso ogni singolo centro
    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 Decision2014-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-16
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