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    Summary
    EudraCT Number:2017-004675-31
    Sponsor's Protocol Code Number:AMCmedonc17-010
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-15
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-004675-31
    A.3Full title of the trial
    A randomized Phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy
    Een gerandomiseerd fase II onderzoek met liposomaal irinotecan in combinatie met S1 in vergelijking met liposomaal irinotecan en 5-Fluorouracil bij patiënten die eerder behandeling hebben gehad met een op gemcitabine gebaseerd regime voor alvleesklierkanker
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised study for second line treatment with nal-IRI and S1 in pancreatic cancer.
    2e lijns studie met nal-IRI en S1 voor patiënten met alvleesklierkanker
    A.4.1Sponsor's protocol code numberAMCmedonc17-010
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    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 supportUniversity of Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointEva van Daalen
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31205668229
    B.5.5Fax number+31206919743
    B.5.6E-mailtrialmedonc@amc.nl
    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 ONIVYDE
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameonivyde
    D.3.2Product code EMA/515476/2016
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPAuricular use
    Intraamniotic use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIrinotecanhydrochlorid
    D.3.9.1CAS number 97682-44-5
    D.3.9.2Current sponsor codeIrinotecanhydrochlorid
    D.3.9.3Other descriptive nameIRINOTECAN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02772MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4,3
    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.IMP: 2
    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 Teysuno
    D.2.1.1.2Name of the Marketing Authorisation holderNordic Group BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameteysuno
    D.3.2Product code EMA/20503/2012
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTEGAFUR
    D.3.9.1CAS number 150863-82-4
    D.3.9.2Current sponsor codetegafur
    D.3.9.4EV Substance CodeSUB10870MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGIMERACIL
    D.3.9.1CAS number 103766-252
    D.3.9.3Other descriptive nameGIMERACIL
    D.3.9.4EV Substance CodeSUB21055
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4,35
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOTERACIL POTASSIUM
    D.3.9.1CAS number 2207-75-2
    D.3.9.3Other descriptive nameOTERACIL POTASSIUM
    D.3.9.4EV Substance CodeSUB21056
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11,8
    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.IMP: 3
    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 fluorouracil
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare Limited,
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 name5 fluorouracil
    D.3.2Product code EMA/706456
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfluorouracil
    D.3.9.1CAS number 51-21-8
    D.3.9.2Current sponsor codefluorouracil accord
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    pancreatic cancer
    pancreas kanker
    E.1.1.1Medical condition in easily understood language
    pancreatic cancer
    alvleesklier kanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose (MTD) of nal-IRI when co-administered with fixed dose S1 in patients with metastatic pancreatic cancer.
    Phase II part: Efficacy between the treatment arms in terms of progression free survival.
    fase I deel: vaststellen maximaal tolereerbare dosis en dosis limiterende bijwerkingen, als nal-IRO wordt toegevoegd aan S1
    fase II deel: effectiviteit van de behandeling met nal-IRI en S1, uitgedrukt in progressie vrije overleving
    E.2.2Secondary objectives of the trial
    Overall survival
    Response rate according to RECIST 1.1
    Adverse events according to NCI CTC version 4.0
    Quality of life
    Overall survival
    Response rate volgens RECIST 1.1
    Adverse events volgens NCI CTC versie 4.0
    Kwaliteit van leven
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Able to understand and provide written informed consent
    ≥ 18 years of age
    Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
    Documented metastatic disease
    Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine treatment
    Adequate hepatic, renal and hematological function
    Caucasian
    In staat zijn een informed consent te begrijpen en te tekenen
    ≥ 18 jaar
    Histologisch of cytologisch bewezen adenocarcinoom van de pancreas
    Gemetastaseerde ziekte
    Eerder behandeld met gemcitabine of een gemcitabine bevattende therapie, of binnen 6 maanden na stop adjuvant gemcitabine progressie van ziekte
    Goede lever-, nier en beenmergfunctie
    Caucasisch
    E.4Principal exclusion criteria
    KPS < 70
    Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 2
    Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
    NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings
    Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician’s opinion might compromise the patient’s health
    Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
    Known hypersensitivity to any of the components of liposomal irinotecan (nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
    Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
    History of severe and unexpected reactions to fluoropyrimidine therapy
    Known dihydropyrimidine dehydrogenase (DPD) deficiency
    Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of liposomal irinotecan (nal-IRI).
    Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine
    KPS < 70
    Klinisch significante gastro-intestinale aandoening (o.a. hepatitis, bloedingen, inflammatie, diarree > graad 2)
    Ernstige arteriele thromboembolische gebeurtenissen in de afgelopen 6 maanden (myocard infarct, instabiele angina pectoris, herseninfarct)
    NYHA klasse III or IV congestief hartfalen, ventriculaire arrhythmieen of oncontroleerbare bloeddruk, afwijkend ECG, wat klinisch significant Active infectie of niet verklaarde temperatuur >38.5°C (excluding tumor feverexclusief tumor koorts)
    CYP3A-enzym inducers/inhibitors en/of sterke UGT1A inhibitors
    Bekende overgevoeligheid voor (een onderdeel van) liposomaal irinotecan (nal-IRI), irinotecan, fluoropyrimidines, en/ of leucovorin.
    Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
    In de voorgeschiedenis onverwachte reactie op fluoropyrimidine behandeling
    Bekende dihydropyrimidine dehydrogenase (DPD) deficientie
    Borst voeding, zwangerschap, postieve zwangerschapstest, niet bereid om voorzorgsmaatregelen te nemen om zwangerschap te voorkomen.
    Behandeling met DPD emmers in de afgelopen 4 weken.
    E.5 End points
    E.5.1Primary end point(s)
    Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose (MTD) of nal-IRI when co-administered with fixed dose S1 in patients with metastatic pancreatic cancer.
    Phase II part: Efficacy between the treatment arms in terms of progression free survival.

    fase I deel: vaststellen maximaal tolereerbare dosis en dosis limiterende bijwerkingen, als nal-IRO wordt toegevoegd aan S1
    fase II deel: effectiviteit van de behandeling met nal-IRI en S1, uitgedrukt in progressie vrije overleving
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation with CTscan/ MRI will take place every 2 months
    Evaluatie met behulp van en CTscan/ MRI vindt iedere 2 weken plaats
    E.5.2Secondary end point(s)
    Overall survival
    Response rate according to RECIST 1.1
    Adverse events according to NCI CTC version 4.0
    Quality of life
    Overall survival
    Response rate volgens RECIST 1.1
    Adverse events volgens NCI CTC versie 4.0
    Kwaliteit van leven
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation with CTscan/ MRI will take place every 2 months
    Adverse events will be evaluated every 2 weeks
    Quality of life will be evaluated every 2 months
    Evaluatie met behulp van en CTscan/ MRI vindt iedere 2 weken plaats
    Bijwerkingen worden iedere 2 weken geevalueerd
    Kwaliteit van leven wordt iedere 2 maanden geevalueerd
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    liosomal irinotecan and 5-fluorouracil
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 80
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 120
    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 for late toxicity every 8 weeks and report date of death
    Volgen voor late toxiciteit elke 8 weken en datum van overlijden rapporteren
    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 Decision2019-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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