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    Summary
    EudraCT Number:2019-004686-41
    Sponsor's Protocol Code Number:IBA1160
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-004686-41
    A.3Full title of the trial
    MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study.
    MyRisk: Evaluación de la eficacia y seguridad de Akynzeo® oral en pacientes que reciben MEC con alto riesgo de desarrollar náuseas y vómitos inducidos por la quimioterapia (CINV) según una herramienta de predicción. Un estudio multinacional y multicéntrico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study.
    MyRisk: Evaluación de la eficacia y seguridad de Akynzeo® oral en pacientes que reciben MEC con alto riesgo de desarrollar náuseas y vómitos inducidos por la quimioterapia (CINV) según una herramienta de predicción. Un estudio multinacional y multicéntrico.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and safety evaluation of oral Akynzeo®
    Evaluación de la eficacia y seguridad de Akynzeo® oral
    A.4.1Sponsor's protocol code numberIBA1160
    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 SponsorHelsinn Healthcare SA
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHelsinn Healthcare SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut biostatistiky a analýz, s.r.o.
    B.5.2Functional name of contact pointHelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressPoštovská 68/3
    B.5.3.2Town/ cityBrno
    B.5.3.3Post code60200
    B.5.3.4CountryCzechia
    B.5.4Telephone number+420515915 100
    B.5.6E-mailhelpdesk@biostatistika.cz
    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 Akynzeo
    D.2.1.1.2Name of the Marketing Authorisation holderHelsinn Birex Pharmaceuticals Ltd.
    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 nameAkynzeo
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNetupitant
    D.3.9.3Other descriptive nameNETUPITANT
    D.3.9.4EV Substance CodeSUB130488
    D.3.10 Strength
    D.3.10.1Concentration unit µCi/mg microcurie(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPALONOSETRON
    D.3.9.1CAS number 135729-56-5
    D.3.9.4EV Substance CodeSUB09593MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µCi/mg microcurie(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    Patients treated with IV moderately emetogenic chemotherapy and at high risk of chemotherapy induced nausea and vomiting (CINV)
    Pacientes tratados con quimioterapia IV moderadamente emetógena y con alto riesgo de náuseas y vómitos inducidos por la quimioterapia (CINV)
    E.1.1.1Medical condition in easily understood language
    Patients treated with chemotherapy and at high risk of chemotherapy induced nausea and vomiting (CINV)
    Pacientes tratados con quimioterapia y con alto riesgo de náuseas y vómitos inducidos por la quimioterapia (CINV)
    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 evaluate if the use of NEPA (netupitant and palonosetron) in patients treated with IV moderately emetogenic chemotherapy and at high risk of CINV is more effective in preventing CINV than standard of care antiemetics over three cycles of chemotherapy
    Evaluar si el uso de NEPA (netupitant y palonosetrón) en pacientes tratados con quimioterapia intravenosa moderadamente emetógena y con alto riesgo de CINV es más eficaz para prevenir las CINV que los antieméticos de tratamiento de referencia durante tres ciclos de quimioterapia.
    E.2.2Secondary objectives of the trial
    2. Evaluate acute (0 to 24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) CINV indicators in each cycle of chemotherapy. Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles.
    CINV indicators are nausea and vomiting, their intensity and frequency and Quality of Life in the acute, delayed and overall period.
    3. Evaluate the predictive role of potential risk factors in the development of CINV over three cycles of chemotherapy
    4. Evaluate the safety profile of the antiemetic drug over three cycles of chemotherapy
    5. Explore the effect of CINV on daily activities and quality of life in patients receiving moderately-emetogenic chemotherapy over three cycles of chemotherapy
    6. Evaluate resource utilization and health economic outcome
    2. Evaluar los indicadores de CINV graves (0 a 24 horas), tardíos (>24 a 120 horas) y generales (0 a 120 horas) en cada ciclo de quimioterapia. El tiempo 0 se define como la hora de inicio de la administración de la quimioterapia en el día 1 de cada uno de los tres ciclos. Los indicadores de las CINV son las náuseas y los vómitos, su intensidad y frecuencia, y la calidad de vida en el periodo grave, tardío y global.
    3. Evaluar la función predictiva de los posibles factores de riesgo en el desarrollo de CINV durante tres ciclos de quimioterapia.
    4. Evaluar el perfil de seguridad del fármaco antiemético durante tres ciclos de quimioterapia.
    5. Explorar el efecto de las CINV sobre las actividades diarias y la calidad de vida en pacientes que reciben quimioterapia moderadamente emetógena durante tres ciclos de quimioterapia.
    6. Evaluar la utilización de recursos y los resultados económicos de la salud.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients aged ≥18 years
    - Patients with a risk score of ≥ 13 as calculated by the algorithm (specified in the protocol)
    - Signed Informed consent
    - Both sexes
    - Patients with diagnosis of any cancer scheduled and intended to be treated for three consecutive cycles with a single dose of any IV MEC regimen, per cycle, including adjuvant or neo-adjuvant chemotherapy
    - Patients with ECOG performance status 0, 1 or 2
    - Use of Standard of Care defined as a 5-HT3 RA + Dexamethasone (or equivalent corticosteroid) based-regimen on day 1 of chemotherapy for CINV prevention
    - Naïve and non- naïve to chemotherapy
    - The enrolled women should be a) of non-childbearing potential or b) of childbearing potential using highly effective contraceptive measures and having a negative urine pregnancy test done by health care team within 1-24 hours before dosing the antiemetic treatment in both arms and outcome recorded in the medical records
    - Able to comply with study requirements
    - Pacientes adultos ≥18 años
    - Pacientes con una puntuación de riesgo ≥13 calculada por el algoritmo, ver la sección 3.6.3.1. Periodo basal/examen: VISITA 0
    - Consentimiento informado firmado
    - Ambos sexos
    - Pacientes con diagnóstico de cualquier tipo de cáncer programado y destinado a ser tratado durante tres ciclos consecutivos con una dosis única de cualquier régimen de MEC IV, por ciclo, incluida la quimioterapia adyuvante o neoadyuvante
    - Pacientes con estado de rendimiento ECOG 0, 1 o 2
    - Uso del tratamiento de referencia definido como un AR 5-HT3 + dexametasona (o un corticoesteroide equivalente) en el día 1 de la quimioterapia para la prevención de las CINV
    - Pacientes con o sin tratamiento previo de quimioterapia
    - Las mujeres inscritas deberán a) no estar en edad reproductiva o b) estar en edad reproductiva utilizando medidas anticonceptivas altamente eficaces y tener una prueba de embarazo en orina negativa realizada por el equipo de salud dentro de 1 a 24 horas anteriores a la dosificación del tratamiento antiemético en ambos grupos de tratamiento y el resultado registrado en la historia clínica
    - Capaz de cumplir con los requisitos del estudio
    E.4Principal exclusion criteria
    - Patients receiving highly emetogenic chemotherapy (including anthracycline+cyclophosphamide-based chemotherapy)
    - Patients receiving oral moderately emetogenic chemotherapy drugs
    - Patients receiving opioids within 2 weeks prior to trial enrollment (longer use allowed)
    - Use of olanzapine as prophylaxis of CINV
    - Patients scheduled to receive radiotherapy concurrently with chemotherapy
    - Any illness or condition that, in the opinion of the physician, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient.
    - Patients with mechanical risk factors for nausea (i.e. intestinal obstruction)
    - Patients with liver disease (as nausea is a common presenting symptom)
    - Patients with metabolic risk factors for nausea (i.e. electrolyte imbalances causing nausea/vomiting)
    - Chronic treatment with steroids (with the exception of inhaled or topical steroids)
    - Pregnancy and/or breast-feeding women
    - Women of childbearing potential refusing to use highly effective contraception during the whole study treatment and up to one month after study treatment with Akynzeo®
    - Use of Standard of Care including an NK-1 RA-based regimen to prevent CINV
    - Pacientes que reciben quimioterapia altamente emetógena (incluyendo quimioterapia basada en antraciclina + ciclofosfamida).
    - Pacientes que reciben fármacos quimioterapéuticos moderadamente emetógenos por vía
    oral.
    - Pacientes que recibieron opioides en las 2 semanas anteriores a la inscripción en el ensayo (se permite un uso más prolongado).
    - Uso de la olanzapina como profilaxis de las CINV.
    - Pacientes programados para recibir radioterapia simultáneamente con quimioterapia.
    - Cualquier enfermedad o condición que, en opinión del médico, pueda confundir los resultados del estudio o plantear riesgos injustificados en la administración del producto en la investigación al paciente.
    - Pacientes con factores de riesgo mecánicos de náuseas (es decir, obstrucción intestinal).
    - Pacientes con enfermedad hepática (ya que las náuseas son un síntoma común de presentación).
    - Pacientes con factores de riesgo metabólico de náuseas (es decir, desequilibrios electrolíticos que provocan náuseas/vómitos).
    - Tratamiento crónico con esteroides (a excepción de los esteroides inhalados o tópicos).
    - Mujeres embarazadas o en periodo de lactancia.
    - Mujeres en edad reproductiva que se niegan a utilizar métodos anticonceptivos altamente eficaces durante todo el tratamiento del estudio y hasta un mes después del tratamiento del estudio con Akynzeo®.
    - Uso del tratamiento de referencia, incluyendo un régimen basado en el AR NK-1 para prevenir
    las CINV.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the proportion of complete responses (no emetic episode and no rescue medication) over three cycles of chemotherapy after the start of the MEC administration.
    El criterio de evaluación primario será proporción de pacientes con respuesta completa (RC, definida como ausencia de episodios eméticos, sin medicamentos de rescate) a lo largo de tres ciclos de
    quimioterapia tras el inicio de la administración del MEC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured at patients last visit following 3 chemotherapy cycles
    En la última visita de los pacientes tras 3 ciclos de quimioterapia
    E.5.2Secondary end point(s)
    • Complete response during the acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle;
    • No emetic episode during the acute, delayed and overall phase and daily in each cycle;
    • Number of vomiting episodes during the acute, delayed and overall phase and daily in each cycle;
    • No rescue medication during the acute, delayed and overall phase and daily in each cycle;
    • No significant nausea (maximum MAT scale = 2) during the acute, delayed and overall phase and daily in each cycle;
    • No nausea (MAT scale = 0) during the acute, delayed and overall phase and daily in each cycle;
    • Complete protection (no emetic episode, no rescue medication and no significant nausea) during the acute, delayed and overall phase and daily in each cycle
    • Nausea and Vomiting-related quality of life indicators (through the Functional Living Index Emesis scale)
    • Collection of chemotherapy delays and/or dose reductions (Delay of chemotherapy administration due to CINV will be also evaluated as part of health economic endpoints, see below)
    Health economic endpoints will be evaluated during the study cycles:
    • Number of days and daily doses of rescue medication administered for the treatment of CINV
    • Number of re-hydration bags given for at least grade 2 vomitings (CTCAE v5)
    • The number of days of unplanned hospitalisations related to CINV and department of hospitalization (type of ward)
    • The number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner)
    • The number of unplanned laboratory test including those at unplanned hospitalisations due to CINV
    • Discontinuation of chemotherapy treatment due to CINV
    • Delay of chemotherapy administration due to CINV
    • Days of absence from work
    • Respuesta completa durante la fase grave (0 a 24 horas), fase tardía (>24 a 120 horas), general (0 a 120 horas) y diaria en cada ciclo;
    • Ningún episodio emético durante la fase grave, tardía y general, y diariamente en cada ciclo;
    • Número de episodios de vómitos durante la fase grave, tardía y general, y diariamente en cada ciclo;
    • No hay medicación de rescate durante la fase grave, tardía y general, y diariamente en cada ciclo;
    • No hay náuseas significativas (escala máxima de MAT = 2) durante la fase grave, tardía y general, y diariamente en cada ciclo;
    • Ausencia de náuseas (escala MAT = 0) durante la fase grave, tardía y general, y diariamente en cada ciclo;
    • Protección completa (ningún episodio emético, ninguna medicación de rescate y ninguna náusea significativa) durante la fase grave, tardía y general, y diariamente en cada ciclo;
    • Indicadores de calidad de vida relacionados con las náuseas y los vómitos (a través de la escala Functional Living Index Emesis);
    • Recogida de retrasos en la quimioterapia o reducciones de dosis (el retraso en la administración de quimioterapia debido a las CINV también se evaluará como parte de los criterios de evaluación económicos de salud, véase más adelante)
    Los datos de los resultados de las CINV se recogerán de forma prospectiva durante los primeros 5 días de quimioterapia y durante tres ciclos consecutivos al utilizar los diarios estandarizados de los pacientes traducidos a los idiomas locales.
    Durante los ciclos del estudio se evaluarán los siguientes criterios de evaluación económico-sanitarios:
    • Número de días y dosis diarias de medicación de rescate administrada para el tratamiento de las CINV
    • Número de bolsas de rehidratación administradas para vómitos de al menos grado 2 (CTCAE v5)
    • El número de días de hospitalizaciones no planificadas relacionadas con la CINV y el departamento de hospitalización (tipo de sala)
    • El número de visitas médicas ambulatorias y de consultas sanitarias debidas a las CINV (por ejemplo, el médico de cabecera)
    • El número de pruebas de laboratorio no planificadas, incluidas las hospitalizaciones no planificadas debido a las CINV
    • Interrupción del tratamiento de quimioterapia debido a las CINV
    • Retraso en la administración de la quimioterapia debido a las CINV
    • Días de ausencia del trabajo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Complete response during the acute (0-24h}, delayed phase (25-120h), overall (0-120h) and daily in each cycle
    Respuesta completa durante la fase aguda (0-24h}, fase retardada (25-120h), global (0-120h) y diaria en cada ciclo
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    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) 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    China
    Czechia
    Germany
    Greece
    Spain
    Switzerland
    United Kingdom
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    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
    E.8.9.2In all countries concerned by the trial days31
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 530
    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)
    Akynzeo is a licensed drug already available on European market that can be prescribed to patients.
    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 Decision2022-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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