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    Summary
    EudraCT Number:2018-002767-26
    Sponsor's Protocol Code Number:LyRICX
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-002767-26
    A.3Full title of the trial
    Liposomal iRInotecan, Carboplatin or oXaliplatin in the first line treatment of esophagogastric cancer: a randomized phase 2 study (LyRICX)
    Liposomaal iRInotecan, Carboplatin of oXaliplatin als eerste lijns behandeling van slokdarm-maagkanker: een gerandomiseerde fase 2 studie (LyRICX)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Liposomal iRInotecan, Carboplatin or oXaliplatin in the treatment of metastatic or irresectable esophageal or gastric cancer: a randomized phase 2 study (LyRICX)
    Liposomaal iRInotecan, Carboplatin of oXaliplatin als behandeling voor uitgezaaide, of niet te opereren slokdarm of maagkanker: een gerandomiseerd fase 2 onderzoek (LyRICX)
    A.3.2Name or abbreviated title of the trial where available
    LyRICX
    LyRICX
    A.4.1Sponsor's protocol code numberLyRICX
    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 pointStudy Coordinator
    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.5.6E-mailtrialmedonc@amc.uva.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 holderServier
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    gastroesophageal cancer
    oesophagus- en maagcarcinoom
    E.1.1.1Medical condition in easily understood language
    gastroesophageal cancer
    slokdarm- en maagkanker
    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
    To compare the progression free survival and neurotoxity of first line treatment with F-Nal-IRI, CapCar and CapOx.
    Vergelijken van progressie vrije overleving en neurotoxiciteit van 3 FU-doublets.
    E.2.2Secondary objectives of the trial
    Secondary endpoints
    − Overall survival
    − Response rate according to RECIST 1.1
    − Adverse events according to NCI CTC version 5.0
    − Quality of life
    − Percentage of patients proceeding to subsequent lines of treatment after progression and describe the types of treatment
    − Reasons for forgoing subsequent treatment after progression

    Exploratory endpoints
    • Relative abundance of stroma and tumor immune infiltrate in metastatic tumor tissue as predictor of response to treatment and survival.
    • Stromal markers, including ADAM12 in metastatic tumor tissue and blood as predictor of response to treatment and survival.
    • Patient derived tumor organoids to assess markers of response to treatment and identify resistance pathways.
    • Baseline ctDNA levels and changes in ctDNA as a marker of response to treatment.
    • Baseline characteristics of and changes in the fecal microbiome as a biomarker for response to treatment and toxicity.
    • Cost effectiveness.
    Secondaire eindpunten
    −Overleving
    −Response rate volgens RECIST 1.1
    −Bijwerkingen volgens NCI CTC version 5.0
    −Kwaliteit van leven
    −Percentage van patients dat aan een volgende lijn behandeling start en de inhoud van die behandelingen
    −Redenen voor het starten van de volgende lijnen van behandeling

    Exploratoratieve eindpunten
    •Relatieve toename van stroma en tumor immuun infiltraten in weefsel en deze vergelijken met respons op deze behandeling en overleving.
    •Stromale markers, inclusief ADAM12 in weefsel en bloed en deze vergelijken met respons op deze behandeling en overleving.
    •Maken van tumororganoiden om te correleren met in vivo respons op behandeling en resistentie mechanismen te onderzoeken.
    •Meten van baseline ctDNA spiegels en veranderingen in ctDNA en deze vergelijken met respons op deze behandeling.
    •Baseline en veranderingen in het fecale microbiome als een biomarker voor respons op behandeling en bijwerkingen van de behandeling.
    •Kosteneffectiviteit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    − Male or female adult patients (≥ 18 years).
    − Patients with histologically confirmed diagnosis of metastatic or irresectable HER2 negative adenocarcinoma of the stomach or oesophagus; patients with HER2 positive disease are eligible when treatment with trastuzumab is contraindicated. If histology cannot be obtained, cytology is acceptable to prove metastatic disease.
    − Patients with metastatic or irresectable adenocarcinoma of the stomach or oesophagus not pre-treated with chemotherapy or radiotherapy for irresectable or metastatic disease. Palliative radiotherapy on the primary tumor or a metastatic lesion is allowed if other untreated lesions eligible for evaluation are present.
    − Measurable disease as assessed by RECIST 1.1
    − ECOG (WHO) performance status 0-2
    − Patient has adequate bone marrow and organ function
    - volwassen patienten (≥ 18 jaar)
    -histologisch bewezen gemetastaseerd of irresectabel her 2 negatief adenocarcinoom van slokdarm of maag
    −meetbare ziekte volgens RECIST 1.1
    −ECOG (WHO) performance status 0-2
    -patienten met gemetastaseerd of irresectabel her 2 negatief adenocarcinoom van slokdarm of de maag die nog niet behandeld zijn met chemotherapie of radiotherapie voor irresectabele of gemetastaseerde ziekte. Palliatieve radiotherapie van de primaire tumor is toegestaan als andere niet behandelde laesies evalueerbaar zijn.
    E.4Principal exclusion criteria
    −Past or current malignancy other than entry diagnosis interfering with prognosis of metastatic esophagogastric cancer.
    de aanwezigheid van een andere maligniteit die interfereert net de prognose van de slokdarm-maakkanker
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival and neurotoxicity
    Progressie vrije overleving en neurotoxiciteit
    E.5.1.1Timepoint(s) of evaluation of this end point
    CT scan every 9 weeks,
    questionnaire neurotoxicity every 3 weeks
    CT scan elke 9 weken
    vragenlijst neurotoxiciteit elke 3 weken
    E.5.2Secondary end point(s)
    − Overall survival
    − Response rate according to RECIST 1.1
    − Adverse events according to NCI CTC version 5.0
    − Quality of life
    − Percentage of patients proceeding to subsequent lines of treatment after progression and describe the types of subsequent treatments
    − Reasons for forgoing subsequent treatment after progression
    − Overall survival
    − Response rate volgens RECIST 1.1
    − Bijwerkingen volgens NCI CTC version 5.0
    − Kwaliteit van leven
    − Percentage van patients die met een volgende lijn behandeld worden en het beschrijven van die behandeling
    − Redenen voor het niet doorgaan met een volgende lijn na progressie
    E.5.2.1Timepoint(s) of evaluation of this end point
    CT scan every 9 weeks,
    questionnaire neurotoxicity every 3 weeks
    questionnaire quality of life every 9 weeks
    CT scan elke 9 weken
    vragenlijst neurotoxiciteit elke 3 weken
    vragenlijst kwaliteit van leven elke 9 weken
    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 Yes
    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 No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned37
    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 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
    Last visit of the last subject
    laatste bezoek van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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
    subjects with incurable disease
    Patienten met een ongeneeslijke ziekte
    F.4 Planned number of subjects to be included
    F.4.1In the member state269
    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)
    none
    geen
    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 Decision2018-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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