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    Summary
    EudraCT Number:2014-004473-16
    Sponsor's Protocol Code Number:SL001-2.0
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-03-17
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2014-004473-16
    A.3Full title of the trial
    Prospective study investigating efficacy of lanreotide on decrease of chemotherapy induced diarrhoea (CID) in patiens with colorectal carcinoma.
    Prospektivní studie zkoumající účinnost lanreotidu na snížení průjmu vyvolaného chemoterapií u pacientů s kolorektálním karcinomem
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study investigating efficacy of a medicine lanreotide on decrease of chemotherapy induced diarrhoea (CID) in patiens with cancer of colon and rectum.
    Studie zkoumající účinnost léku lanreotid na snížení průjmu vyvolaného chemoterapií u pacientů s rakovinou tlustého střeva a konečníku
    A.3.2Name or abbreviated title of the trial where available
    STOPRHEA
    STOPRHEA
    A.4.1Sponsor's protocol code numberSL001-2.0
    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 SponsorMasarykův onkologický ústav
    B.1.3.4CountryCzech Republic
    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 supportMasarykův onkologický ústav
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMasarykův onkologický ústav
    B.5.2Functional name of contact pointOddělení klinických hodnocení
    B.5.3 Address:
    B.5.3.1Street AddressŽlutý kopec 7
    B.5.3.2Town/ cityBrno
    B.5.3.3Post code656 53
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number00420543136611
    B.5.6E-maildemlova@mou.cz
    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 120 MG INJ SOL 1X0.5ML/120MG
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma, Boulogne Billancourt, Francie
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 in pre-filled syringe
    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 ACETATE
    D.3.9.1CAS number 127984-74-1
    D.3.9.3Other descriptive nameLANREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB14326MIG
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Chemotherapy induced diarrhoea that is resistant to common treatment including loperamide in patients with colorectal carcinoma
    Chemoterapií indukovaný průjem u pacientů s kolorektálním karcinomem, který je rezistentní na obvyklou léčbu zahrnující loperamid
    E.1.1.1Medical condition in easily understood language
    Chemotherapy induced diarrhoea that is resistant to common treatment including loperamide in patients with cancer of colon and rectum
    Chemoterapií vyvolaný průjem u pacientů s rakovinou tlustého střeva a konečníku, na který nezabírá obvyklá léčba zahrnující loperamid
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Definition of efficacy of lanreotid in the therapy of CID which is defined as a rate of regression of CID to grade G1 from the entry value (grade G3 or G4) according to CTCAE v.4.03
    Stanovení účinnosti lanreotidu při léčbě CID, která je definována jako míra regrese CID ke stupni G1 proti vstupní hodnotě (z G3 nebo G4) dle CTCAE v.4.03
    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives:
    1. Rate of regression of CID against the entry value – 2 grades (from G3 to G1 and from G4 to G2). 2-grades amelioration of CID is clinically significant. Usually it allows possibility of outpatient treatment without need of infusion support.
    2. Monitoring of following intensity and density of chemotherapy (following of dosage and interval)
    3. Influence of lanreotide treatment on quality of life (use of questionnaires EQ – 5D)

    Secondary safety objectives: assessment of occurence of AE –descriptive assessment of frequency of occurence, seriousness and types of all found AE.
    Sekundární cíle účinnosti:
    1. míra regrese CID proti vstupní hodnotě o 2 stupně (z G3 na G1 a z G4 na G2). Zlepšení CID o 2 stupně má zřetelný klinický význam, obvykle je pak možná ambulantní léčba bez nutnosti infusní podpory.
    2. sledování dodržení dávkové intenzity a density chemoterapie (dodržení dávky a intervalu)
    3. vliv léčby lanreotidem na kvalitu života s využitím dotazníků EQ – 5D

    Sekundární cíle bezpečnosti: hodnocení výskytu AE - deskriptivní zhodnocení frekvence výskytu, závažnosti a typů všech zjištěných AE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Pacient with histologically verified colorectal carcinoma.
    2 Pacient treated by chemotherapy based on 5-FU, capecitabine or irinotecan in adjuvant or paliative indication. This includes regimens: FUFA Mayo, FUFA DeGramont, FOLFOX, FOLFIRI, bolus regimens with 5-FU and oxaliplatine or irinotecan, monotherapy by 5-FU, capecitabine or irinotecan. Combination of chemotherapy and targeted therapy is allowed (bevacizumab, cetuximab, panitumumab).
    3 Patients with CID grade ≥3 according the CTCAE classification version 4.03 (increase of number of stools of more than 7 per day against the entry state, incontinence, if the diarrhoea and its complications are the reason for hospitalisation, significant increase of bowel movements by colonostomy against the entry state, diarrhoea inducing limitation of independence in common everyday activities).
    Note: Patients with colonostomy who receive enteral alimentation can be enrolled.
    4 CID resistant to diet and common medication which should include loperamide. This resistance is defined as a persisting diarrhoea grade ≥3 after 24-hours treatment by loperamide, the maximum dose allowed 8cps/day. In the first treatment line of CID also other common medication can be used (diphenoxylate, atropine, carbo medicinalis).
    5 Age ≥18 years and ≤80 years.
    6 Patients with PS WHO ≤3 with anticipated survival at least 3 months.
    7 Patients understands the informed consent and signs it.
    1 Pacient s histologicky verifikovaným kolorektální karcinomem.
    2 Pacient léčený chemoterapií na bázi 5-FU, kapecitabinu nebo irinotekanu v adjuvantní nebo paliativní indikaci. K takovým režimům patří FUFA Mayo režim, FUFA DeGramont, FOLFOX, FOLFIRI, bolusové režimy s 5-FU a oxaliplatinou nebo irinotekanem, monoterapie 5-FU, kapecitabinem nebo irinotekanem. Je povolena kombinace chemoterapie s cílenou léčbou (bevacizumab, cetuximab, panitumumab).
    3 Pacienti s CID stupně ≥3 podle klasifikace CTCAE verze 4.03 (vzestup počtu stolic o více než 7 za den proti vstupnímu stavu, inkontinence, pokud je průjem a jeho komplikace důvodem k hospitalizaci, výrazné zvýšení odchodu stolice kolostomií proti vstupnímu stavu, průjem vyvolává omezení sebeobsluhy při každodenních běžných činnostech).
    Poznámka: Je možné zařadit pacienty s kolostomií, pacienty, kterým je podávána enterální výživa.
    4 CID musí být rezistentní k léčbě režimovým opatřením (dieta) a obvyklou medikací, která musí zahrnovat loperamid. Tato rezistence je definována jako přetrvávající průjem stupně ≥3 po 24hodinové léčbě loperamidem, kdy může být použita maximální dávka 8cps/den. V první linii léčby CID může být použita také jiná obvyklá medikace (difenoxylát, atropin, živočišné uhlí).
    5 Pacient ve věku ≥18 let a ≤75 let.
    6 Pacient s PS WHO ≤3 s předpokládaným přežitím nejméně 3 měsíce.
    7 Pacient chápe informovaný souhlas a podepíše ho.
    E.4Principal exclusion criteria
    1 CID during concomitant chemoradiotherapy.
    2 Somatostatine analogs used for treatment of the current CID. Previous medication by short-acting somatostatine analogs or long-acting somatostatine analogs is allowed.
    3 Patients with proven or suspected chronic irradiation enteritis.
    4 Known allergy to Somatuline Autogel 60mg, 90mg or 120mg nor another somatostatine analogs.
    5 Anamnesis of acute or chronic enteritis, malabsorption syndrome or idiopatic bowel inflammation (Crohn's disease, ulcerative collitis).
    6 Bowel fistula, short bowel syndrome.
    7 Anamnesis of cholecystitis in cholecystolithiasis, if cholecystectomy have not been performed.
    8 Serious hepatic disease. Values of liver function parameters (bilirubin, ALT, AST, GGT, ALP) >3 fold of maximum normal values.
    9 Diarrhoea (≥ grade 2) or bowel incontinence from another reasons than CID (e.g. epidemiological anamnesis, dietary error).
    10 Pregnancy or breastfeeding (exluded by anamnesis)
    11 Patients who participated in some other clinical study - during 30 days prior to screening.
    1 CID při konkomitantní chemoradioterapii.
    2 Analoga somatostatinu použita k léčbě aktuálně probíhající CID. Je povolena předchozí aplikace krátkodobě působících analog somatostatinu nebo dlouhodobě působících analog somatostatinu.
    3 Pacienti s prokázanou nebo suspektní chronickou iradiační enteritidou.
    4 Známá alergie na Somatuline Autogel 60mg, 90mg nebo 120mg nebo jiná somatostatinová analoga.
    5 Anamnéza akutní nebo chronické enteritidy, malabsorpčního syndromu nebo idiopatického střevního zánětu (Crohnova nemoc, ulcerosní kolitida).
    6 Střevní fistule, syndrom krátkého střeva.
    7 Anamnéza cholecystitidy při cholecystolithiáze, pokud nebyla provedena cholecystektomie.
    8 Vážné jaterní onemocnění. Hodnota parametrů jaterní funkce (bilirubin, ALT, AST, GGT, ALP) >3násobek maximálních normálních hodnot.
    9 Průjem (≥ stupeň 2) nebo inkontinence stolice z jiných příčin než CID (např. epidemiologická anamnéza, dietní chyba).
    10 Těhotenství nebo kojení (vyloučeno anamnesticky)
    11 Pacienti, kteří se účastnili jiné klinické studie - během 30 dnů před screeningem.
    E.5 End points
    E.5.1Primary end point(s)
    Paremeter of efficacy is the rate of regression of CID to grade G1 from the entry value (grade G3 or G4) during 7 days from the first administration of the investigational medicinal product.
    Parametrem účinnosti je míra regrese CID z G4 nebo G3 na G1 během 7 dnů - od prvního podání hodnoceného léčivého přípravku.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days
    7 dní
    E.5.2Secondary end point(s)
    1. Rate of regression of CID against the entry value – 2 grades (from G3 to G1 and from G4 to G2) during 7 days from the first administration of the investigational medicinal product.
    2. Compliance with intensity and density of chemotherapy (compliance with dosage and interval), asessed after the cycle of chemotherapy following the first application of lanreotide.
    3. Compliance with intensity and density (compliance with dosage and interval), asessed after the last chemotherapy in this trial.
    4. Quality of life -use of questionnaires EQ – 5D, assessed at the enrollment, day 7, one month after the first administration of lanreotide and two months after the first administration of lanreotide.
    1. míra regrese CID proti vstupní hodnotě o 2 stupně (z G3 na G1 a z G4 na G2) během 7 dnů - od prvního podání hodnoceného léčivého přípravku
    2. dodržení dávkové intenzity a density chemoterapie (dodržení dávky a intervalu) – hodnoceno po podání následujícího cyklu chemoterapie po první aplikaci lanreotidu
    3. dodržení dávkové intenzity a denzity (dodržení dávky a intervalu), hodnoceno po poslední chemoterapii v rámci studie.
    4. kvalita života s využitím dotazníků EQ – 5D, hodnoceno při vstupu do studie, den 7 a jeden a dva měsíce po prvním podání lanreotidu.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During 7 days from the first administration of the investigational medicinal product.
    2. Assessed after the cycle of chemotherapy following the first application of lanreot
    3. Asessed after the last chemotherapy in this trial.
    4. Assessed at the enrollment, day 7, one month after the first administration of lanreotide and two months after the first administration of lanreotide.
    1. Během 7 dnů - od prvního podání hodnoceného léčivého přípravku
    2. Hodnoceno po podání následujícího cyklu chemoterapie po první aplikaci lanreotidu
    3. Hodnoceno po poslední chemoterapii v rámci studie.
    4. Hodnoceno při vstupu do studie, den 7 a jeden a dva měsíce po prvním podání lanreotidu.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    poslední návštěva posledního pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days14
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state60
    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)
    Follow-up Visit - 5(±1) weeks after the last administration of IMP
    Follow-up kontrola - 5(±1) týdnů po poslední aplikaci hodnoceného léčivého přípravku
    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 Decision2016-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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