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    Summary
    EudraCT Number:2011-004981-13
    Sponsor's Protocol Code Number:TIDE-11-10
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-17
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-004981-13
    A.3Full title of the trial
    Phase II, Double-blind, Randomized, Two-stage, Placebo-controlled Proof of Concept Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide (ZP1846) Administered s.c. in the Prevention of Chemotherapy Induced Diarrhea (CID)
    Fázis 2, kettős vak, randomizált, kétlépcsős, placebo kontrollos, igazoló vizsgálat, 5-FU alapú kemoterápiában részesülő vastag- és végbélrákos betegeken, a szubkután alkalmazott elsiglutide (ZP1846) hatékonyságának vizsgálatára a kemoterápia okozta hasmenés (CID) megelőzésében.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in Colorectal Cancer Patients treated with Chemotherapy to Assess the Efficacy of a new drug (elsiglutide) administered subcutaneously in the prevention of diarrhea induced by chemotherapy
    Kemoterápiában részesülő vastag- és végbélrákos betegeken, fázis 2, kettős vak, randomizált, kétlépcsős, placebo kontrollos, elsiglutid (ZP1846) hatékonyságának vizsgálatára a kemoterápia okozta hasmenés (CID) megelőzésében.
    A.4.1Sponsor's protocol code numberTIDE-11-10
    A.5.4Other Identifiers
    Name:IND Number:73491
    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 SponsorHelsinn Healthcare SA
    B.1.3.4CountrySwitzerland
    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 supportHelsinn Healthcare SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPSI CRO Hungary Pharma Support LLC
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressSzabadság tér 7, 3 em.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post codeH-1054
    B.5.3.4CountryHungary
    B.5.4Telephone number+3615556755
    B.5.5Fax number+3615553750
    B.5.6E-mailRAbudapest@psi-cro.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 No
    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 nameElsiglutide
    D.3.2Product code ZP1846
    D.3.4Pharmaceutical form Powder for 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 INNelsiglutide
    D.3.9.2Current sponsor codeZP1846
    D.3.9.3Other descriptive nameH-His-Gly-Glu-Gly-Ser-Phe-Ser-Ser-Glu-Leu-Ser-Thr-Ile-Leu-Asp-Ala-Leu-Ala-Ala-Arg-Asp-Phe-Ile-Ala-Trp-Leu-Ile-Ala-Thr-Lys-Ile-Thr-Asp-Lys-Lys-Lys-Lys-Lys-Lys-NH2, acetate salt (IUPAC)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 typePeptide obtained by solide phase peptide synthesis.
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chemotherapy Induced Diarrhea
    kemoterápia okozta hasmenés
    E.1.1.1Medical condition in easily understood language
    Diarrhea induced by chemotherapy in patients with colorectal cancer
    Kemoterápia okozta hasmenés vastag- és végbélrákos betegeken.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057013
    E.1.2Term Diarrhea post chemotherapy
    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
    The main objective of this proof of concept study will be to obtain data on the efficacy of Elsiglutide (ZP1846) in preventing CID in patients with colorectal cancer receiving 5-FU based chemotherapy (FOLFOX4 or FOLFIRI regimen) in comparison to placebo.
    Ennek az igazoló vizsgálatnak az a fő célja, hogy adatokat szerezzünk be az elsiglutide (ZP1846) hatékonyságáról a CID megelőzésében olyan betegeknél, akik vastagbélrákjuk kezelésére 5-FU alapú kemoterápiában részesülnek (FOLFOX4, vagy FOLFIRI), szemben azokkal, akik placebót kapnak.
    E.2.2Secondary objectives of the trial
    Safety and tolerability of the administered repeated doses of Elsiglutide (ZP1846) will be evaluated and the pharmacokinetics (PK) of Elsiglutide (ZP1846), and its metabolites ZP2242 and ZP2712 will be investigated in a subset of patients in each treatment arm.
    Ezen kívül kiértékeljük az elsiglutide (ZP1846) többszöri adagjának biztonságosságát és tolerabilitását, valamint vizsgáljuk farmakokinetikai szempontból mindegyik kezelési karon az elsiglutide-ot (ZP1846), valamint metabolitjait a ZP2242-t és a ZO2712-t.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PK and immunogenicity evaluations (as per Protocol)
    E.3Principal inclusion criteria
    1. Written informed consent;
    2. Male or female patient 18 years of age or over;
    3. Confirmed diagnosis of colorectal cancer;
    4. Chemotherapy naïve patient;
    5. Patient scheduled to receive a FOLFOX4 or FOLFIRI chemotherapy regimen
    6. A performance status of ≤ 2 according to the Eastern Cooperative Oncology Group (ECOG);
    7. Non-fertile patient or fertile patient (male or female) using reliable contraceptive measures;
    8. Female patient of childbearing potential need to have a negative pregnancy test at screening.
    1. Írásos bele egyezés a vizsgálatba;
    2. 18 éves, vagy attól idősebb;
    3. Diagnózissal alátámasztott kolorektális rákban szenved;
    4. Eddig még nem kapott kemoterápiát
    5. A beteg a tervek szerint FOLFOX4 vagy FOLFIRI kemoteráouás kezelést fog kapni a következő ütemezés és adagolás szerint.
    6. Az EAstern Cooprerative Oncology Group (ECOG) státusz ≤ 2 (lásd a B Mellékletet).
    7. Nem fogamzóképes beteg, vagy olyan nemzőképes/fogamzóképes férfi, vagy nőbeteg, aki hatásos fogamzásgátlást alkalmaz1
    8. Negatív terhességi teszt a szűréskor a fogamzóképes nőbetegek esetében.
    E.4Principal exclusion criteria
    1. Inability to understand study procedures and/or cooperate with the study Investigator;
    2. Any investigational drugs within 30 days before enrollment in the study or foreseen use of investigational agents during the study;
    3. Patient with any type of ostomy;
    4. Any previous radiotherapy to the abdomen or pelvis;
    5. Scheduled to receive radiotherapy to abdomen or pelvis during the study (Day 1 to Day 14);
    6. Scheduled to receive any concomitant chemotherapeutic agent other than FOLFOX4 or FOLFIRI agents (Oxaliplatin, Irinotecan, Folinic acid, 5-FU) from Day 1 to Day 14;
    7. Previous use or scheduled to receive monoclonal antibodies (e.g. bevacizumab, cetuximab, etc) during the study (from Day 1 to Day 14);
    8. Major surgery within the previous 3 weeks;
    9. Any type of condition leading to chronic diarrhea, including but not limited to inflammatory bowel diseases (e.g. ulcerative colitis and Crohn’s disease), chronic diarrhea of presumed or confirmed infectious origin and irritable bowel syndrome;
    10. Any diarrhea in the 48 hours preceding study drug administration;
    11. Use of anti-diarrheal agents within the 48 hours prior to study drug administration;
    12. Use of laxatives within 7 days prior to study drug administration;
    13. Use of antibiotics within 7 days prior to study drug administration ;
    14. History of chronic (≥ 30 consecutive days) use of laxatives;
    15. Active and ongoing systemic infection;
    16. Lactating woman;
    17. History of hypersensitivity or allergies to drugs or compounds potentially related to this investigational drug class;
    18. Previous exposure to GLP-2 or other compounds in this investigational drug class;
    19. Patient with abnormalities in selected laboratory parameters (according to pre-defined criteria);
    20. Concomitant bleeding disorders;
    21. Other serious concomitant illness, which could interfere with the study;
    22. Patient who participated in a previous study with Elsiglutide ZP1846.
    1.Nem érti a vizsgálati eljárásokat és/vagy nem képes együttműködni a vizsgálóval;
    2.Valamiféle vizsgálati készítményt kapott a vizsgálatba való beválasztást megelőző 30 napon belül, illetve a tervek szerint a vizsgálat ideje alatt valamilyen vizsgálati készítmény alkalmazását tervezik;
    3.Bármely típusú ostomia
    4.Korábban kapott sugárterápia a has, vagy a medence területén;
    5.A tervek szerint sugárterápiára kerül sor a has, vagy a medence területén a vizsgálat ideje alatt (1.-14. nap során);
    6.A tervek szerint a FOLFOX4, vagy FOLFIRI (Oxaliplatin, irinotecan, folinsav, 5-FU) szereken kívül bármi más konkomitáns kemoterápiás szert fog kapni az 1.-14. nap során.
    7.Korábban már kapott monoklonális antitesteket, illetve a tervek szerint kapni fog ilyet a vizsgálat során (az 1-14 napon) (például bevacizumabot, cetuximabot, stb.)
    8.Nagyműtéten esett át az előző 3 hétben.
    9.Bármi olyan betegsége van, ami krónikus hasmenéshez vezet, többek között IBS (például colitis ulcerosa és a Crohn betegség), krónikus hasmenés, amit feltehetőleg, vagy bizonyíthatóan fertőzés okoz, és az irritábilis bélszindróma;
    10.A készítmény alkalmazását megelőző 48 órán belül bármiféle hasmenés;
    11.A készítmény alkalmazását megelőző 48 órán belül bármiféle hasmenés elleni készítmény alkalmazása;
    12.Hashajtó alkalmazása a készítmény alkalmazását megelőző 7 napon belül;
    13.Antibiotikum alkalmazása a készítmény alkalmazását megelőző 7 napon belül;
    14.Krónikus (≥30 egymást követő napon) hashajtózás a kórtörténetben;
    15.Aktív és jelenleg fennálló szisztémás fertőzés;
    16.Szoptatás;
    17.Kórtörténetben potenciális túlérzékenység, vagy allergia a most vizsgált készítménnyel egy osztályba tartozó gyógyszerre, vagy annak valamely vegyületére.
    18.Korábban már kapott GLP-2-t, vagy más, ebbe a gyógyszerosztályba tartozó vegyületet;
    19.Olyan betegek, akik egyes kiválasztott laborértékeket tekintve a normálistól eltérő értékeket mutatnak (előre meghatározott kritériumok alapján);
    20.Egyidejűleg vérzéses rendellenességeik vannak;
    21.Más, egyidejűleg fennálló súlyos betegségük van, ami befolyásolná a vizsgálatot;
    22.Az a beteg, aki az elsiglutide-ZP1846-tal korábban végzett vizsgálatban már részt vett.
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients experiencing no diarrhea from Day 1 to Day 14.
    Az elsődleges hatékonvsági végpont azoknak a betegeknek a száma, akik az 1.-14. napon nem tapasztalnak hasmenést.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 14, on a daily basis.
    E.5.2Secondary end point(s)
    1. Proportion of patients experiencing Grades ≥2 diarrhea (NCI-CTCAE v. 4.0) from Day 1 to Day 14;
    2. Worst grade of diarrhea according to NCI-CTCAE v. 4.0 (from Day 1 to Day 14);
    3. Time to occurrence of diarrhea, defined as the first day in which a Grade ≥ 1 diarrhea is assessed (from Day 1 to day 14);
    4. Number of days with presence of Grade ≥ 1 diarrhea (from Day 1 to Day 14);
    5. Number of days with presence of Grade ≥ 2 diarrhea (from Day 1 to Day 14);
    6. Number of days with presence of at least one bowel movement accompanied by urgency (from Day 1 to 14);
    7. Number of days with presence of at least one episode of fecal incontinence (from Day 1 to 14);
    8. Proportion of patients who required i.v. fluids due to CID (from Day 1 to 14);
    9. Proportion of patients who required changes to the primary therapy (chemotherapy dose reduction, delay or change to regimen) due to CID as of Day 2, Day 14 and as of Day 28;
    10. Proportion of patients who use rescue medication (i.e. medication used for treatment of diarrhea) from Day 1 to Day 14.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 14, on a daily basis (except for secondary endpoint 9 which has to be performed at Day 28 as well).
    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 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.6.13.1Other scope of the trial description
    Immunogenicity testing
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Hungary
    Romania
    Russian Federation
    E.8.7Trial has a data monitoring committee Yes
    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 years0
    E.8.9.1In the Member State concerned months9
    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 months9
    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: 98
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 138
    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)
    Expected normal treatment of the investigated condition.
    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 Decision2012-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-11
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