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    Summary
    EudraCT Number:2021-003311-26
    Sponsor's Protocol Code Number:77839
    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:2021-08-09
    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 number2021-003311-26
    A.3Full title of the trial
    DAVINCY trial: optimal Duration of (fos)aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children: a double-blind placebo-controlled crossover randomized phase III trial’
    DAVINCY: Verlengd gebruik (fos)aprepitant ter voorkoming van misselijkheid en braken veroorzaakt door chemotherapie in kinderen: een dubbel blind placebo gecontroleerd crossover gerandomizeerde fase 3 studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    optimal Duration of (fos)aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children
    optimale duur van (fos)aprepitant profylaxe voor misselijkheid en braken geïnduceerd door chemotherapie bij kinderen
    A.3.2Name or abbreviated title of the trial where available
    DAVINCY
    DAVINCY
    A.4.1Sponsor's protocol code number77839
    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 SponsorPrinses Máxima Centrum
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrinses Máxima Centrum
    B.5.2Functional name of contact pointHead Trial & Data Center
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 25
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CS
    B.5.3.4CountryNetherlands
    B.5.6E-mailtrialmanagement@prinsesmaximacentrum.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 IVEMEND
    D.2.1.1.2Name of the Marketing Authorisation holderMSD
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameIVEMEND
    D.3.2Product code IVEMEND
    D.3.4Pharmaceutical form Powder for 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.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 aprepitant
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameaprepitant
    D.3.2Product code RVG 121086
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    prolonged anti emetic treatment
    verlengde anti emetische behandeling
    E.1.1.1Medical condition in easily understood language
    treatment of nausea and vomitting
    behandeling van misselijkheid en braken
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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 evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the prevention of delayed CINV (complete remission in the 24-72 hours after the final dose of chemotherapy) in children. The current 3-day regimen is compared to a regimen of (fos)aprepitant prophylaxis during the complete course of chemotherapy in the same patient in subsequent similar courses of chemotherapy, creating an intrapatient comparison of anti-emetic control.
    Het evalueren van het effect van langdurige profylaxe met (fos)aprepitant op het voorkomen of minder aanwezig zijn van misselijkheid en braken veroorzaakt door chemotherapie bij kinderen. (uitblijven van misselijkheid en braken 24-72 uur na de laatste dosering chemotherapie). Het huidige 3-daagse regime wordt vergeleken met een regime van (fos)aprepitant profylaxe tijdens de volledige kuur van chemotherapie bij dezelfde patiënt in daaropvolgende vergelijkbare kuren van chemotherapie, waardoor een intra-patiënt vergelijking van anti-emetische controle ontstaat.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the pre-vention of acute and overall chemotherapy induced nausea and vomiting (CINV) in children.
    - To compare the effect of prolonged duration of (fos)aprepitant prophylaxis regarding the efficacy endpoint of no vomiting, regardless of rescue medication use, in the acute, delayed and overall phases.
    - To assess the safety and tolerability of (fos)aprepitant according to a prolonged dosing regimen.
    - To evaluate the pharmacokinetics of (fos)aprepitant during a prolonged dosing regi-men by constructing a population pharmacokinetics (PK) model.
    - To assess the improvement of complaints of CINV in children during prolonged (fos)aprepitant dosing regimen by using the validated pediatric nausea assessment tool (PeNAT).17
    Percentage patiënten dat:
    - volledige respons bereikt tijdens chemotherapie tot 24 uur na de laatste dosis chemotherapie (acute fase)
    - volledige respons bereikt tijdens zowel de acute als de vertraagde fase (algehele fase)
    Tijd vanaf het begin van emetogene chemotherapie tot:
    - de eerste episode van braken
    - het eerste gebruik van reddingsmedicatie
    Veiligheid van langdurig gebruik van (fos)aprepitant (AE's die door de onderzoekers als gerelateerd worden beschouwd)
    Farmacokinetische (PK) parameters (d.w.z. klaring en distributievolume) en beïnvloedende PK-co variabelen als chemotherapeutica
    Verbetering van CINV-klachten volgens de Pediatric Nausea Assessment tool (PeNAT) voor kinderen van 4-18 jaar
    Kosteneffectiviteit van langdurig (fos)aprepitant doseringsschema
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The eligibility criteria are:
    - Patients must be ≥ 6 months to ≤ 18 years at time of study entry. and weight ≥ 6kg
    - Patients must have a documented malignancy.
    - Patients need to receive moderate or highly emetogenic chemotherapy blocks, or chemotherapy not previously tolerated due to vomiting, for a minimum duration of 4 days.
    - Chemotherapy schedules need to contain two similar courses of chemotherapy, which do not necessarily have to be consecutive courses.
    - No symptomatic primary or metastatic CNS malignancy causing nausea or vomiting.
    - Patients do not receive scheduled blocks of chemotherapy containing corticosteroids as part of anti-tumour treatment during the study period.
    - Patients aged greater than 16y with a Karnofsky score of 60 or more or patients aged 16y or less with a Lansky Play performance score of 60 or more.
    - Patient must have a life expectancy of 3 months or more.
    - Patients must not use antiemetic treatment within 48h before treatment.
    - Patients must not receive radiation therapy to the abdomen or pelvis in the week before treatment
    - Patient must not use benzodiazepines or opioids initiated within 48h before treatment, except for single doses of triazolam, temazepam, or midazolam.
    - Continuation of chronic benzodiazepine or opioid therapy is permitted provided it was initiated ≥48 hours prior to study drug administration.
    - In patients on chronic warfarin, acenocoumarol, tolbutamide or phenytoin (me-tabolised by CYP2C9) therapy should be monitored closely during treatment with (fos)aprepitant and for 14 days following each course of (fos)aprepitant.
    - No use of CYP3A4 substrates/inhibitors within 7 days, or no CYP3A4 inducers within 30 days of treatment
    - Patient’s serum creatinine must be ≤ 1.5 x institutional upper limit of normal (ULN) ac-cording to age.
    - Patient’s AST and ALT must be ≤ 5 x institutional ULN.
    - Patient’s total bilirubin must be ≤ 1.5 x institutional ULN
    - Patient must not have a history of QT prolongation
    - Female patients of childbearing potential must have a negative urine or serum preg-nancy test confirmed prior to enrollment.
    - Female patients with infants must agree not to breastfeed their infants while on this study.
    - Male and female patients of child-bearing potential must agree to use a highly effec-tive method of contraception approved by the investigator during the study, following the CTFG recommendations.
    - Patients have no history of prior grade 3/4 allergic reaction to any of the study drugs
    - Patients have no underlying gastrointestinal disease that may interfere with the ab-sorption of the medication
    De geschiktheidscriteria zijn:
    - Patiënten moeten ≥ 6 maanden tot ≤ 18 jaar oud zijn op het moment van deelname aan het onderzoek. En gewicht van ≥ 6kg.
    - Patiënten moeten een gedocumenteerde maligniteit hebben.
    - Patiënten moeten matige of sterk emetogene chemotherapie krijgen, of chemotherapie die voorheen niet werd verdragen vanwege braken, gedurende een minimumduur van 4 dagen.
    - Chemotherapieschema's moeten twee vergelijkbare kuren chemotherapie bevatten, die niet noodzakelijkerwijs opeenvolgende kuren hoeven te zijn.
    - Geen symptomatische primaire of gemetastaseerde maligniteit van het CZS die misselijkheid of braken veroorzaakt.
    - Patiënten krijgen tijdens de onderzoeksperiode geen geplande blokken chemotherapie die corticosteroïden bevatten als onderdeel van een antitumorbehandeling.
    - Patiënten ouder dan 16 jaar met een Karnofsky-score van 60 of meer of patiënten van 16 jaar of jonger met een Lansky Play-prestatiescore van 60 of meer.
    - De patiënt moet een levensverwachting hebben van 3 maanden of meer.
    - Patiënten mogen geen anti-emetische behandeling gebruiken binnen 48 uur voor de behandeling.
    - Patiënten mogen in de week voor de behandeling geen bestraling van de buik of het bekken krijgen
    - De patiënt mag geen benzodiazepines of opioïden gebruiken binnen 48 uur voor de behandeling start, behalve voor enkelvoudige doses triazolam, temazepam of midazolam.
    - Voortzetting van chronische benzodiazepine- of opioïdtherapie is toegestaan ​​op voorwaarde dat deze ≥48 uur voorafgaand aan de toediening van het onderzoeksgeneesmiddel is gestart.
    - Bij patiënten die chronisch warfarine, acenocoumarol, tolbutamide of fenytoïne (gemetaboliseerd door CYP2C9) gebruiken, moet de therapie nauwlettend worden gevolgd tijdens de behandeling met (fos)aprepitant en gedurende 14 dagen na elke kuur met (fos)aprepitant.
    - Geen gebruik van CYP3A4-substraten/-remmers binnen 7 dagen, of geen CYP3A4-inductoren binnen 30 dagen na behandeling
    - Het serumcreatinine van de patiënt moet ≤ 1,5 x de institutionele bovengrens van normaal (ULN) zijn, in overeenstemming met de leeftijd.
    - De AST en ALT van de patiënt moeten ≤ 5 x de institutionele ULN zijn.
    - Het totale bilirubine van de patiënt moet ≤ 1,5 x de institutionele ULN zijn
    - De patiënt mag geen voorgeschiedenis hebben van QT-verlenging
    - Bij vrouwelijke patiënten die zwanger kunnen worden, moet een negatieve urine- of serumzwangerschapstest worden bevestigd voordat ze worden ingeschreven.
    - Vrouwelijke patiënten met baby's moeten ermee instemmen hun baby's geen borstvoeding te geven tijdens deze studie.
    - Mannelijke en vrouwelijke patiënten die zwanger kunnen worden, moeten ermee instemmen een zeer effectieve anticonceptiemethode te gebruiken die tijdens het onderzoek door de onderzoeker is goedgekeurd, volgens de CTFG-aanbevelingen.
    - Patiënten hebben geen voorgeschiedenis van een eerdere allergische reactie van graad 3/4 op een van de onderzoeksgeneesmiddelen
    - Patiënten hebben geen onderliggende gastro-intestinale aandoening die de absorptie van de medicatie kan verstoren
    E.4Principal exclusion criteria
    See E3
    zie E3
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who achieve complete response (no vomiting, no retching and no use of rescue medication) during the 24-72 hours after the final dose of chemotherapy (delayed phase).
    Percentage patiënten dat een volledige respons bereikt (geen braken, niet kokhalzen en geen gebruik van noodmedicatie) gedurende 24-72 uur na de laatste dosis chemotherapie (uitgestelde fase)
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of study
    einde van de studie
    E.5.2Secondary end point(s)
    Proportion of patients who:
    - achieved complete response during the course of chemotherapy until 24h af-ter the final dose of chemotherapy (acute phase)
    - achieved complete response during both the acute and delayed phase (overall phase)
    Time from initiation of emetogenic chemotherapy to:
    o the first vomiting episode
    o the first rescue medication use
    Safety of prolonged use of (fos)aprepitant (AEs considered related by the investiga-tors)
    Pharmacokinetic (PK) parameters (i.e. clearance and volume of distribution) and in-fluencing PK co-variates as chemotherapeuticsImprovement of CINV complaints according to the Pediatric Nausea Assessment tool (PeNAT) for children aged 4-≤18 years
    Cost-effectiveness of prolonged (fos)aprepitant dosing regimen
    Percentage patiënten dat:
    - volledige respons bereikt tijdens chemotherapie tot 24 uur na de laatste dosis chemotherapie (acute fase)
    - volledige respons bereikt tijdens zowel de acute als de vertraagde fase (algehele fase)
    Tijd vanaf het begin van emetogene chemotherapie tot:
    - de eerste episode van braken
    - het eerste gebruik van reddingsmedicatie
    Veiligheid van langdurig gebruik van (fos)aprepitant (AE's die door de onderzoekers als gerelateerd worden beschouwd)
    Farmacokinetische (PK) parameters (d.w.z. klaring en distributievolume) en beïnvloedende PK-co variabelen als chemotherapeutica
    Verbetering van CINV-klachten volgens de Pediatric Nausea Assessment tool (PeNAT) voor kinderen van 4-18 jaar
    Kosteneffectiviteit van langdurig (fos)aprepitant doseringsschema
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of study
    einde van de studie
    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 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.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 No
    E.8.1.6Cross over Yes
    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 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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 76
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 45
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state76
    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)
    Treatment is not changing after finishing the study. We hope for future chemocourses we are able to improve antiemetic control in child oncology.
    De behandeling verandert niet na het beëindigen van de studie. We hopen dat we met toekomstige chemokuren de anti-emetische controle in de kinderoncologie kunnen verbeteren.
    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 Decision2021-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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