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    Summary
    EudraCT Number:2017-000207-24
    Sponsor's Protocol Code Number:BO39694
    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:2017-03-31
    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 number2017-000207-24
    A.3Full title of the trial
    A MULTICENTER, INTERNATIONAL, ROLLOVER STUDY OF ALECTINIB IN PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE OR REARRANGED DURING TRANSFECTION (RET)-POSITIVE CANCER
    ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, INTERNACIONAL DE ALECTINIB EN PACIENTES CON TUMORES POSITIVOS PARA QUINASA DEL LINFOMA ANAPLÁSICO (ALK) O REORDENACIÓN DURANTE LA TRANSFECCIÓN (RET)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Rollover Study of Alectinib in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
    Estudio de extensión de alectinib en pacientes con tumores positivos para quinasa del linfoma anaplásico (ALK) o reordenación durante la transfección (RET)
    A.4.1Sponsor's protocol code numberBO39694
    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 SponsorRoche Farma S.A.U. que realiza el ensayo en España y que actúa como representante de F.Hoffmann-La Roche Ltd.
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913248172
    B.5.6E-mailspain.start_up_unit@roche.com
    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 No
    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 nameAlectinib
    D.3.2Product code RO5424802/F03
    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 INNALECTINIB
    D.3.9.2Current sponsor codeRO5424802
    D.3.9.3Other descriptive nameALK INHIBITOR
    D.3.9.4EV Substance CodeSUB178557
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 Xalkori
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 nameXalkori
    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 INNCRIZOTINIB
    D.3.9.1CAS number 877399-52-5
    D.3.9.3Other descriptive nameCRIZOTINIB
    D.3.9.4EV Substance CodeSUB32267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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 Xalkori
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 nameXalkori
    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 INNCRIZOTINIB
    D.3.9.1CAS number 877399-52-5
    D.3.9.3Other descriptive nameCRIZOTINIB
    D.3.9.4EV Substance CodeSUB32267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Anaplastic lymphoma kinase (ALK)-positive or rearranged during transfection (RET)-positive cancer
    Tumores positivos para quinasa del linfoma anaplásico (ALK) o reordenación durante la transfección (RET)
    E.1.1.1Medical condition in easily understood language
    ALK positive cancer is any type of cancer that has a change in the ALK gene. RET positive cancer is any type of cancer that has a change in the RET gene.
    El cáncer ALK positivo es cualquier tipo de cáncer que tiene un cambio en el gen ALK. El cáncer RET positivo es cualquier tipo de cáncer que tiene un cambio en el gen RET.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To provide continued treatment with alectinib or crizotinib as applicable to patients with ALK- or RET-positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure
    Ofrecer tratamiento continuado con alectinib o crizotinib, según sea el caso, a pacientes con tumores ALK o RET positivo que han sido incluidos previamente en un estudio de alectinib promocionado por Roche y que continúan obteniendo beneficio clínico del tratamiento con alectinib o crizotinib en el momento de finalizar el estudio original.
    E.2.2Secondary objectives of the trial
    •To assess long-term safety of alectinib therapy
    Evaluar la seguridad a largo plazo del tratamiento con alectinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible
    -Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form
    -Ability and willingness to comply with the protocol, in the investigator's judgment
    -For women who are not postmenopausal (>=12 months of non−therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug.
    -For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug.
    - Pacientes incluidos en un ensayo clínico de alectinib promocionado por Roche que estén obteniendo beneficio clínico del tratamiento con alectinib o crizotinib en el momento de terminar el estudio original y en los que no sea posible cambiar el tratamiento del estudio por el fármaco disponible comercialmente.
    - Disponer de datos en el momento de la terminación del estudio requeridos en el estudio original, incluyendo datos de eficacia y seguridad, registrados en el cuaderno de recogida de datos electrónico.
    - Capacidad y disposición para cumplir los requisitos del protocolo, de acuerdo con el criterio del investigador
    -Las mujeres que no se encuentren en fase postmenopáusica (amenorrea no inducida terapéuticamente durante 12 meses) o que no estén esterilizadas quirúrgicamente (con extirpación de ovarios y/o útero) deben comprometerse a practicar la abstinencia sexual o a utilizar uno o varios métodos anticonceptivos combinados que tengan una tasa de fallos de 1% al año durante el período de tratamiento y como mínimo hasta 3 meses después de que reciban la última dosis del fármaco del estudio.
    -Los varones deben comprometerse a practicar la abstinencia sexual o a utilizar un método anticonceptivo que proporcione una tasa de fallos 1% al año, durante el período de tratamiento y como mínimo hasta 3 meses después de la administración de la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    -Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study
    -Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study
    -Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation
    -Pregnant or breastfeeding women
    -Ongoing serious adverse event that has not resolved to baseline level or Grade ≤1 prior to first dose of study treatment in the rollover study
    -Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator
    -Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib
    -Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the patient before trial entry
    - Ausencia de beneficio clínico en el estudio original evidenciada durante la fase de selección de este estudio de extensión
    - Interrupción permanente del tratamiento con alectinib o crizotinib, por el motivo que sea, durante el estudio original o antes de administrar la primera dosis del fármaco del estudio en el estudio de extensión.
    - Evidencia de un acontecimiento adverso que requiera la interrupción permanente del tratamiento, según lo estipulado en el protocolo del estudio original.
    - Mujeres embarazadas o en período de lactancia.
    - Acontecimientos adversos graves en curso que no hayan remitido al valor basal o a grado  1 antes de la administración de la primera dosis del tratamiento del estudio en el estudio de extensión.
    -Interrupción del tratamiento durante más de 21 días debido a un acontecimiento adverso, desde la administración de la última dosis de alectinib o crizotinib en el estudio original. Los acontecimientos adversos en curso que requieran la interrupción temporal del tratamiento deben haber remitido al grado basal o haberse estabilizado sin que se requieran más interrupciones del tratamiento, de acuerdo con el criterio del investigador.
    -Uso de potentes inhibidores o inductores del citocromo P450 3A en los 14 días previos a la administración de la primera dosis del tratamiento en este estudio y durante el tratamiento con crizotinib.
    -Cualquier circunstancia psicológica, familiar, sociológica o geográfica que impida potencialmente el cumplimiento de los requisitos del protocolo del estudio y/o los procedimientos de seguimiento; estas situaciones se deben considerar con el paciente antes de su inclusión en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    -Not applicable
    -No aplica
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Not applicable
    -No aplica
    E.5.2Secondary end point(s)
    1. Incidence of serious and non-serious adverse events and adverse events of special interest
    2. Selected safety laboratory test measurements
    3. Number of Deaths occurring on study
    1. Incidencia de acontecimientos adversos graves y no graves y eventos adversos de interés especial
    2. Medidas seleccionadas de pruebas de laboratorio de seguridad
    3. Número de muertes ocurridas en el estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Throughout the study
    1-3. A lo largo del estudio
    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 Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    To provide continued treatment with alectinib or crizotinib as applicable to patients with ALK- or RET-positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure
    Ofrecer tratamiento continuado con alectinib o crizotinib, según sea el caso, a pacientes con tumores ALK o RET positivo que han sido incluidos previamente en un estudio de alectinib promocionado por Roche y que continúan obteniendo beneficio clínico del tratamiento con alectinib o crizotinib en el momento de finalizar el estudio original.
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    rollover study (to offer continious treatment option for patents from parent studies)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Crizotinib (Xalkori)
    Crizotinib (Xalkori)
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    France
    Italy
    Korea, Republic of
    Russian Federation
    Spain
    Taiwan
    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
    The study will end when the last patient has completed the safety follow-up visit 4 weeks after the last dose of study drug. Because of the nature of the study, the total length of study will not be estimated.
    El estudio terminará cuando el último paciente haya completado la visita de seguimiento de seguridad 4 semanas después de la administración de la última dosis del fármaco del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 240
    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)
    The sponsor does not intend to provide alectinib or crizotinib to patients upon early withdrawal or after completion of this rollover study.
    El Sponsor no tiene la intención de proporcionar alectinib o crizotinib a los pacientes después de la retirada temprana o después de completar este estudio de extensión.
    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 Decision2017-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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