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    Summary
    EudraCT Number:2013-002174-43
    Sponsor's Protocol Code Number:A-48-52030-269
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-002174-43
    A.3Full title of the trial
    AN INTERNATIONAL, MULTICENTRIC, PROSPECTIVE, OPEN LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 MG ASSOCIATED TO STANDARD OF CARE IN THE TREATMENT OF CLINICAL SYMPTOMS ASSOCIATED WITH INOPERABLE MALIGNANT INTESTINAL OBSTRUCTION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN INTERNATIONAL, MULTICENTRIC, PROSPECTIVE, OPEN LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 MG ASSOCIATED TO STANDARD OF CARE IN THE TREATMENT OF CLINICAL SYMPTOMS ASSOCIATED WITH INOPERABLE MALIGNANT INTESTINAL OBSTRUCTION
    A.3.2Name or abbreviated title of the trial where available
    IMIO
    A.4.1Sponsor's protocol code numberA-48-52030-269
    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 NV
    B.1.3.4CountryBelgium
    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 NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIPSEN NV
    B.5.2Functional name of contact pointVincent De Ruyter
    B.5.3 Address:
    B.5.3.1Street AddressGuldensporenpark 87
    B.5.3.2Town/ cityMerelbeke
    B.5.3.3Post code9820
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3209243 96 15
    B.5.6E-mailvincent.de.ruyter@ipsen.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 Somatuline Autogel injectable 120 mg
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 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 INNLANREOTIDE
    D.3.9.1CAS number 108736-35-2
    D.3.9.4EV Substance CodeSUB08402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 intestinal obstruction
    E.1.1.1Medical condition in easily understood language
    Inoperable malignant intestinal obstruction
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10022690
    E.1.2Term Intestinal obstruction NOS
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of lanreotide Autogel lanreotide Autogel 120 mg for the relief of vomiting due to inoperable malignant intestinal obstruction in patients without nasogastric tube AND to assess the efficacy of lanreotide Autogel 120 mg to remove a nasogastric tube without the recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a nasogastric tube
    E.2.2Secondary objectives of the trial
    1) To evaluate the impact on Quality of Life (Edmonton Symptom Assessment System) of lanreotide Autogel 120 mg assessed by both the patient and the caregiver

    2) To assess the efficacy of lanreotide Autogel 120 mg for the relief of other clinical symptoms due to inoperable malignant intestinal obstruction :
    - General activity (Karnofsky score)
    - Nausea (number of daily episodes)
    - Pain (Visual analogue scale)
    - Complete/incomplete obstruction: passage of stools

    3) To assess the symptom (nausea and vomiting) improvement delay

    4) To assess the pharmacokinetic profile of lanreotide in patients with inoperable malignant intestinal obstruction

    Safety Objectives :
    To assess the clinical and biological safety of the study treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Written informed consent before any study related procedure
    2) Male and female patients age 18 years or older at the time of enrolment
    3) Diagnosis of an intestinal obstruction of malignant origin
    4) In case of peritoneal carcinomatosis, confirmation by CT or MRI scan within the 3 months preceding the inclusion in the study
    5) Confirmed as inoperable after surgical advice
    6) Patient with a nasogastric tube OR presenting with 3 or more episodes of vomiting / 24h in the last 48 hours
    7) Estimated life expectancy 1 month or more
    E.4Principal exclusion criteria
    1) Operable obstruction or any subobstruction
    2) Bowel obstruction due to a non-malignant cause (for example : hypokaliaemia, drug side-effects, renal insufficiency, …)
    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) Previous participation in this study
    7) Is likely to require treatment during the study with drugs that are not permitted
    by the study protocol (see Section 9.5).
    8) 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.

    E.5 End points
    E.5.1Primary end point(s)
    Percentage of responding patients before or at D7. A responder is defined as a patient experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any time point between the D1 and D7 (for patients without NGT at baseline) or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the D1 and D7 without vomiting recurrence.
    - Number of daily vomiting episodes recorded on diary cards.
    - Number of days without vomiting
    E.5.1.1Timepoint(s) of evaluation of this end point
    Percentage of responding patients before or at D7
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints And Evaluations:
    Phase 1 : Initial Injection Lanreotide Autogel 120 mg:
    1) Percentage of responding patients before or at D14 (same for D28). A responder is defined as a patient experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any time point between the D1 and D14 (D28) or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the D1 and D14 (D28) without vomiting recurrence.
    - Number of daily vomiting episodes recorded on diary cards.
    - Number of days without vomiting

    2) Time between first injection and clinical response

    3) Changes from baseline in Quality of Life (Edmonton Symptom Assessment System) at Day 7, Day 14 and Day 28 assessed by both the patient and the caregiver.

    4) Changes in daily intensity and frequency at Day 7, Day 14 and Day 28 compared to baseline in
    - General activity (Karnofsky score)
    - Nausea (number of daily episodes)
    - Pain (Visual analogue scale)
    - Complete/incomplete obstruction: passage of stools


    Phase 2 : Second injection Lanreotide Autogel 120 mg :
    1) Overall Percentage of patients continuing from Phase I and confirmed as a responder at the end of phase I , showing a continued response at D35, D42 and D56. A responder is defined as a patient experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any time point between the D1 and D35, D42 and D56 or as a patient in whom the NGT has been removed during at least 3 consecutive days at any time point between the D1 and D35, D42 and D56 without vomiting recurrence.
    - Number of daily vomiting episodes recorded on diary cards.
    - Number of days without vomiting

    2) Changes from baseline in Quality of Life (Edmonton Symptom Assessment System) at Day 35, Day 42 and Day 56 assessed by both the patient and the caregiver.

    Pharmacokinetic Endpoints and Evaluations:
    The PK profile of lanreotide Autogel in patients with IMIO using lanreotide concentration data.

    Safety Endpoints and Evaluations:
    Clinical and biological adverse events and serious adverse events throughout the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Percentage of responding patients before or at D14 (same for D28).
    -Time between first injection and clinical response
    -Changes from baseline in Quality of Life
    -Changes in daily intensity and frequency of
    General activity (Karnofsky score)
    - Nausea (number of daily episodes)
    - Pain (Visual analogue scale)
    - Complete/incomplete obstruction: passage of stools


    -Overall Percentage of patients continuing from Phase I
    -The PK profile of lanreotide Autogel in patients with IMIO
    -Clinical and biological adverse events and serious adverse events throughout the study
    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 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.8.3 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 concerned21
    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
    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 months3
    E.8.9.1In the Member State concerned days
    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: 50
    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 state50
    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 different from the expected normal treatment of that condition
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-09
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