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    Summary
    EudraCT Number:2014-004552-64
    Sponsor's Protocol Code Number:131016
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2014-004552-64
    A.3Full title of the trial
    MISTRAL - Mistletoe therapy in primary and recurrent inoperable pancreatic cancer -
    A phase III prospective, randomized, double blinded, multicenter, parallel group, placebo controlled clinical trial on overall survival and health-related quality of Life
    MISTRAL - Behandling med mistelpreparat vid primär eller recidiverande inoperabel pankreascancer.
    En fas III prospektiv randomiserad dubbelblind, multicenter, parallell grupp, placebokontrollerad klinisk studie på överlevnad och hälsorelaterad livskvalitet.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with a mistletoe preparation for patients with inoperable pancreatic cancer. A double blind placebo controlled multicenter trial investigating whether survival and quality of life can be improved.
    Behandling med mistelpreparat för patienter med inoperabel bukspottkörtel cancer.
    En dubbelblind palcebokontrollerad multicenter studie som undersöker om överlevnad och livskvalitet kan förbättras.
    A.3.2Name or abbreviated title of the trial where available
    MISTRAL (short term for MIStletoe TRiAL)
    MISTRAL (Förkortning för MIStel TRiAL (trial=studie))
    A.4.1Sponsor's protocol code number131016
    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 SponsorCenter for Digestive Diseases, Karolinska University Hospital
    B.1.3.4CountrySweden
    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 supportRegional Cancer Centre
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportGyllenberg Stiftelse
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportRadiumhemmets forskningsfonder
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportOnkologiska klinikens gåvofond
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportDagmar Ferbs Minnesfond
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportIscador AG
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportCancerforskningsfonden Norrland
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportEkhaga stiftelsen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCenter for Digestive Diseases, Karolinska University Hospital
    B.5.2Functional name of contact pointClinnical Trial Unit
    B.5.3 Address:
    B.5.3.1Street AddressGastrocentrum K61, Karolinska University Hospital
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code141 86
    B.5.3.4CountrySweden
    B.5.4Telephone number+468585 828 64
    B.5.5Fax number+468585 837 54
    B.5.6E-mailkathrin.wode@sll.se
    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 Iscador Qu
    D.2.1.1.2Name of the Marketing Authorisation holderIscador AG, Switzerland
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameFermented aqueous extract of Viscum album ssp album (L.) (mistletoe)
    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 INNMistletoe extract
    D.3.9.1CAS number 8500009-17-8
    D.3.9.3Other descriptive nameMISTLETOE EXTRACT
    D.3.9.4EV Substance CodeSUB14585MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.01 to 20
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    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 placeboInjection
    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
    Primary or recurrent inoperable pancreatic cancer
    Primär eller recidiverande inoperabel pankreascancer
    E.1.1.1Medical condition in easily understood language
    Inoperable cancer of the pancreas. First time diagnosis or relapse.
    Inoperabel cancer i bukspottkörteln. Primärdiagnos eller återfall.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is to compare mistletoe therapy to placebo in the endpoint overall survival (time from randomization to death of any cause) in palliative patients with inoperable pancreatic cancer.
    Huvudsyftet är att jämföra behandling med mistelpreparat med placebo avseende överlevnad (tid från randomisering till död av alla orsaker) hos palliativa patienter med inoperabel pankreascancer.
    E.2.2Secondary objectives of the trial
    Key secondary objectives are to compare mistletoe therapy to placebo in the endpoints ”global health”, “physical function”, “fatigue” and “appetite loss” as scales of the EORTC QLQ-C30 questionnaire in palliative patients with inoperable pancreatic cancer.
    Other secondary objectives are to compare mistletoe therapy to placebo in the endpoints body weight, corticosteroid use, adverse events (AE) and costs for supportive care and inpatient care.
    Sekundära huvudsyftet är att jämföra behandling med mistelpreparat med placebo avseende "allmän hälsa", "fysiskt tillstånd", "fatigue" och "aptitförlust" som skalor av EORTC QLQ-C30 formuläret hos palliativa patienter med inoperabel pancreascancer.
    Övriga syften är att jämföra behandling med mistelpreparat med placebo avseende kroppsvikt, kortisonanvändning, adverse events (AE) och kostnadr för palliativ vård och sjukhusvistelser.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1.MISTRAL - Qualitative interview study.
    2. Blood samples for biomarker analysis
    1. MISTRAL - kvalitativ intervju studie.
    2. Venös blodprovstagning för biomarkör analys
    E.3Principal inclusion criteria
    Signed written informed consent
    Age ≥ 18 years
    Histological confirmed inoperable locally advanced or metastatic pancreatic cancer or relapse of pancreatic cancer.
    - Primary diagnosis: if histology is not possible diagnosis is to be confirmed according to local practice sufficient for diagnosis and choice of therapy (such as CA19-9 and CT).
    - Relapse: histology (not required) or diagnosis according to local practice such as clinical signs and/or imaging and/or CA19-9.
    ECOG performance status 0-2
    Signerad informerad samtycke
    Ålder ≥ 18 år
    Histologiskt verifierad inoperabel lokalt avancerad eller metastatserande pankreas cancer eller återfall av pankreascancer.
    - Primärdiagnos: om histologi är omöjligt måste diagnosen bekräftas enligt lokal praxis som anses tillräcklig för diagnos och val av terapi (som CA19-9 och CT).
    - Recidiv: histologi (ej krav) eller diagnosen bekräftas enligt lokal praxis som kliniska symtom och/eller röntgen och/eller CA19-9)
    ECOG performance status 0-2
    E.4Principal exclusion criteria
    Life expectancy less than 4 weeks
    Pregnancy or breastfeeding
    Neuroendocrine tumors of the pancreas (NET)
    Current use of interferon, G-CSF and thymus preparations
    Symptomatic brain edema due to brain metastases
    Known hypersensitivity to mistletoe-containing products
    Current use of mistletoe extract preparations in any form
    Previous, ongoing or planned irreversible electroporation (IRE)
    Chronic granulomatous disease or active autoimmune disease or autoimmune disease with immunosuppressive treatment
    Medical, psychiatric, cognitive or other conditions that may compromise the patient´s ability to understand the patient information, give informed consent, comply with the study protocol or complete the study (e.g. needle phobia).
    Förväntad livslängd mindre än 4 veckor
    Graviditet eller amning
    Neuroendokrina pankreas tumörer (NET)
    Pågående behandling med interferon, G-CSF och thymuspreparat
    Symtomgivande hjärnödem orsakad av hjärnmetastaser
    Känd överkänslighet mot mistelinnehållande produkter
    Pågående användning av mistelpreparat i alla former
    Tidigare, pågående eller planerad irreversibel elektroporation (IRE)
    Kronisk granulomatös sjukdom eller aktiv autoimmun sjukdom eller autoimmun sjukdom under immunosuppresiv behandling
    Medicinska, psykiatriska, kognitiva eller andra tillstånd som skulle kunna äventyra patientens förmåga att förstå patientinformationen, ge informerat samtycke, kunna följa studieprotokollet eller fullfölja studien (som t ex uttalad nål fobi).
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint is Overall Survival (OS) which is defined as time from randomization to death for any reason.
    Primär endpoint är överlevnad som definieras som tiden från randomisering till död av alla orsaker.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At time of death and end of study
    Vid tidpunkten för döden och vid avslutande av studien
    E.5.2Secondary end point(s)
    Key secondary endpoints are: scales for ”global health”, “physical function”, “fatigue” and “appetite loss” according to EORTC QLQ-C30
    Other secondary endpoints are remaining scales for QoL according to EORTC QLQ-C30 and EORTC QLQ-PAN-26, body weight, corticosteroid use, adverse events (AE), costs for supportive care and costs for inpatient care
    Sekundära huvudendpoints är skalorna för "allmän hälsa", "fysiskt tillstånd", "fatigue" och "aptitförlust" enligt EORTC QLQ-C30.
    Övriga endpoints är resterande skalor av EORTC QLQ-C30 och EORTC QLQ-PAN-26, kroppsvikt, kortisonanvändning, adverse events (AE), kostnader för palliativ vård och för sjukhusvård
    E.5.2.1Timepoint(s) of evaluation of this end point
    At each visit in the study
    Vid varje besök i studien
    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 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 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 concerned6
    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
    Sista visit av sista patienten
    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 months6
    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: 240
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients with incurable disease
    Patienter med obotbar sjukdom
    F.4 Planned number of subjects to be included
    F.4.1In the member state290
    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)
    According to the Declaration of Helsinki post-trial treatment with mistletoe extract will be offered to participants after end of treatment. In these cases mistletoe treatment will be reimbursed by Iscador® AG.
    Enligt Deklarationen av Helsinki kommer patienter att erbjudas behandling med mistelpreparat efter avslutat studiedeltagande. Behandlingen kommer att bekostas av Iscador AG.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Institute for Applied Epistemology and Medical Methodology at the University of Witten/Herdecke (IFAEMM)
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Department of Learning, Informatics, Management and Ethics (LIME) and Karolinska University Hospital, Dep. of Oncology
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Regional Cancer Center Stockholm Gotland
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Regional Cancer Center Stockholm/Gotland and Karolinska Institutet, Institute of Learning, Informatics, Medical Manageme
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Immunpathologisches Labor Universität Tübingen
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Karolinska Institutet, Dep. of Neurobiology, caring sciences and society, Div. of Nursing and Dep of Physiology and Phar
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-02
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