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    Summary
    EudraCT Number:2017-003535-11
    Sponsor's Protocol Code Number:2017-003535-11
    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:2018-06-27
    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 number2017-003535-11
    A.3Full title of the trial
    The added value of the H2-antagonist ranitidine in premedication regimens during paclitaxel treatment
    Evaluatie van de meerwaarde van ranitidine als anti-allergiemiddel bij paclitaxel chemotherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study that investigates whether ranitidine has a added value in the prevention of paclitaxel-induced allergic reactions
    Een studie waarin wordt onderzocht of ranitidine een toegevoegde waarde heeft in het voorkomen van allergische reacties op paclitaxel.
    A.3.2Name or abbreviated title of the trial where available
    RANISTOP
    RANISTOP
    A.4.1Sponsor's protocol code number2017-003535-11
    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 SponsorErasmus MC
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMaasstad Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointJ.M. Cox
    B.5.3 Address:
    B.5.3.1Street Address‘s-Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015CE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310107033202
    B.5.6E-mailj.cox@erasmusmc.nl
    B.Sponsor: 2
    B.1.1Name of SponsorMaasstad Hospital
    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 supportErasmus mc
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMaasstad Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaasstad Hospital
    B.5.2Functional name of contact pointE.J. Ruijgrok
    B.5.3 Address:
    B.5.3.1Street AddressMaasstadweg 21
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3079DZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031010291991
    B.5.6E-mailcoxj@maasstadziekenhuis.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Zantac
    D.2.1.1.2Name of the Marketing Authorisation holderGSK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameRanitidine
    D.3.4Pharmaceutical form Solution for injection
    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 INNRANITIDINE
    D.3.9.1CAS number 66357-35-5
    D.3.9.3Other descriptive nameZantac
    D.3.9.4EV Substance CodeSUB10258MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Paclitaxel-induced hypersensitivity reactions
    Overgevoeligheidsreacties ontstaan door paclitaxel
    E.1.1.1Medical condition in easily understood language
    Hypersensitivity reactions as a result of paclitaxel administration
    Overgevoeligheidsreacties als een gevolg van paclitaxel toediening
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 incidence of clinically relevant HSRs (grade ≥3 as per Common Terminology Criteria for Adverse Events; CTCAE version 4.0) during paclitaxel-based chemotherapy with a standard of care premedication regimen with ranitidine compared to an experimental premedication regimen without ranitidine.
    Om de incidentie van klinisch relevante HSR's (graad ≥3 volgens Common Terminology Criteria voor bijwerkingen, CTCAE versie 4.0) te evalueren tijdens paclitaxel-gebaseerde chemotherapie met een standaard van premedicatiebehandeling met ranitidine vergeleken met een experimenteel premedicatie-regime zonder ranitidine.
    E.2.2Secondary objectives of the trial
    1. To determine the severity (grade) of paclitaxel-induced HSR as defined by CTCAE (version 4.0) with and without ranitidine.
    2. To determine the percentages of patients that can be rechallenged (according to standard of care) after an HSR with and without ranitidine.
    3. To determine the number of paclitaxel dosages until first HSR occurrence with and without ranitidine.
    4. To determine the cost-effectiveness of the premedication regimens with and without ranitidine during paclitaxel treatment.
    5. To determine the cumulative dose of paclitaxel at the moment of HSR occurrence with and without ranitidine.
    6. To determine the effect of the removal of ranitidine on the quality of life for patients receiving paclitaxel.
    1. Bepalen van de ernst (graad) van paclitaxel-geïnduceerde HSR zoals gedefinieerd door CTCAE (versie 4.0) met en zonder ranitidine.
    2. Het bepalen van de percentages van patiënten die opnieuw kunnen worden behandeld (volgens de standaardzorg) na een HSR met en zonder ranitidine.
    3. Om het aantal paclitaxel-doseringen te bepalen tot het eerste HSR-optreden met en zonder ranitidine.
    4. Het bepalen van de kosteneffectiviteit van de premedicatie-behandelingen met en zonder ranitidine tijdens de behandeling met paclitaxel.
    5. De cumulatieve dosis paclitaxel bepalen op het moment van optreden van HSR met en zonder ranitidine.
    6. Om het effect te bepalen van het weglaten van ranitidine op de kwaliteit van leven van patiënten die paclitaxel krijgen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 years;
    • Able and willing to give written informed consent;
    • Planned treatment with regular paclitaxel based chemotherapy for any indication and with any dose.
    • Leeftijd ≥18 jaar
    • In staat zijn om en het willen van het tekenen van informed consent
    • Geplande behandeling met chemotherapie bestaande uit minimaal paclitaxel, ongeacht indicatie of dosis
    E.4Principal exclusion criteria
    • Prior treatment with a paclitaxel based regimen;
    • Known hypersensitivity to paclitaxel, carboplatin, docetaxel, ranitidine, dexamethasone, clemastine, granisetron, ondansetron or excipients;
    • Unwilling to stop the use of H2-antagonists for gastroduodenal reflux and ulcer disease. The H2-antagonist should be stopped at least two days before the first paclitaxel infusion (washout). Switching an H2-antagonist to a proton pump inhibitor is allowed.
    • Eerdere behandeling met paclitaxel
    • Bekende overgevoeligheid voor paclitaxel, carboplatin, docetaxel, ranitidine, dexamethason, clemastine, granisetron, ondansetron of hulpstoffen;
    • Niet bereid om het gebruik van H2-antagonisten voor gastroduodenale reflux en maagzweren te stoppen. De H2-antagonist moet minstens twee dagen vóór de eerste paclitaxel-infusie (washout periode) worden gestopt. Het is toegestaan ​​om een ​​H2-antagonist in een protonpompinhibitor te laten veranderen.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be the percentage (%) of patients who experience an HSR CTCAE grade 3, 4 or 5 after paclitaxel infusion, grade determined prospectively by the oncology medical staff.
    De primaire uitkomst zal het percentage (%) van de patiënten zijn dat een HSR CTCAE graad 3, 4 of 5 na paclitaxel-infusie ervaart, prospectief bepaald door de oncologische medische staf.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the primary endpoint will take place when 554 patients have been included and have finished the study. Finishing the study means that a person must have experienced a hypersensitivity reaction on paclitaxel or that he/she has received the last dose of paclitaxel.
    An interim analysis will be performed on the primary endpoint by a DSMB when 185 (33.4%) patients are included and completed the trial.
    Evaluatie van het primaire eindpunt zal plaatsvinden wanneer 554 patiënten zijn geïncludeerd en het onderzoek hebben beëindigd. Afronding van de studie betekent dat een persoon een overgevoeligheidsreactie op paclitaxel heeft gehad of dat hij / zij de laatste dosis paclitaxel heeft gekregen.
    Een interim-analyse zal worden uitgevoerd op het primaire eindpunt door een DSMB wanneer 185 (33,4%) patiënten zijn opgenomen en de proef hebben voltooid.
    E.5.2Secondary end point(s)
    1. To determine the severity (grade) of paclitaxel-induced HSR as defined by CTCAE (version 4.0) with and without ranitidine.
    2. To determine the percentages of patients that can be rechallenged (according to standard of care) after an HSR with and without ranitidine.
    3. To determine the number of paclitaxel dosages until first HSR occurrence with and without ranitidine.
    4. To determine the cost-effectiveness of the premedication regimens with and without ranitidine during paclitaxel treatment.
    5. To determine the cumulative dose of paclitaxel at the moment of HSR occurrence with and without ranitidine.
    6. To determine the effect of the removal of ranitidine on the quality of life for patients receiving paclitaxel.
    1. Bepalen van de ernst (graad) van paclitaxel-geïnduceerde HSR zoals gedefinieerd door CTCAE (versie 4.0) met en zonder ranitidine.
    2. Het bepalen van de percentages van patiënten die opnieuw kunnen worden behandeld (volgens de standaardzorg) na een HSR met en zonder ranitidine.
    3. Om het aantal paclitaxel-doseringen te bepalen tot het eerste HSR-optreden met en zonder ranitidine.
    4. Het bepalen van de kosteneffectiviteit van de premedicatie-behandelingen met en zonder ranitidine tijdens de behandeling met paclitaxel.
    5. De cumulatieve dosis paclitaxel bepalen op het moment van optreden van HSR met en zonder ranitidine.
    6. Om het effect te bepalen van het weglaten van ranitidine op de kwaliteit van leven van patiënten die paclitaxel krijgen.
    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 No
    E.6.3Therapy No
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned5
    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
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 189
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 365
    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 state554
    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)
    Patients may continue the use of ranitidine post trial according to regular treatment.
    Patienten kunnen het gebruik van ranitidine continueren na de studie volgens het reguliere behandelprotocol.
    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 Decision2018-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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