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    Summary
    EudraCT Number:2007-003989-18
    Sponsor's Protocol Code Number:AMR PH GL 2007 CL 001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-08
    Trial results View 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 number2007-003989-18
    A.3Full title of the trial
    Un ensayo de fase III aleatorizado, abierto y multinacional que compara Amrubicina con Topotecán en pacientes con cáncer microcítico pulmonar diseminado o limitado y sensible o resistente al tratamiento, tras fracaso con quimioterapia de primera línea

    A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy
    A.4.1Sponsor's protocol code numberAMR PH GL 2007 CL 001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPharmion Corporation
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Calsed®
    D.2.1.1.2Name of the Marketing Authorisation holderDainippon Sumitomo Pharma Co. Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameamrubicina
    D.3.2Product code CNF3140
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNamrubicina
    D.3.9.1CAS number 110311-30-3
    D.3.9.2Current sponsor codeCNF3140 (drug product)
    D.3.9.3Other descriptive nameSM-5887 (drug substance)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeantraciclina sintética
    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 Hycamtin
    D.2.1.1.2Name of the Marketing Authorisation holderSmithKline Beecham plc
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNtopotecán
    D.3.9.3Other descriptive namehidrocloruro de topotecán
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeDerivado semisintetico del alcaloide camptotecina.
    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
    Extensive or limited and sensitive or refractory SCLC after failure of first-line
    chemotherapy.

    Pacientes con cáncer de pulmón microcítico (CPM) diseminado o limitado y sensible o refractario tras el fracaso de la quimioterapia de primera línea.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10041071
    E.1.2Term Small cell lung cancer stage unspecified
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal es demostrar la superioridad en la supervivencia global de amrubicina (40 mg/m2 administrados como una infusión de 5 minutos una vez al día durante 3 días consecutivos comenzando en el Día 1 de un tratamiento de 21 días) comparada con topotecán (1,5 mg/m2 administrados como una infusión de 30 minutos una vez al día durante 5 días consecutivos comenzando en el Día 1 de un tratamiento de 21 días) en pacientes con cáncer de pulmón microcítico (CPM) diseminado o limitado y sensible o refractario tras el fracaso de la quimioterapia de primera línea.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios importantes son seguir caracterizando el beneficio clínico de la amrubicina comparada con topotecán en cuanto a:
    •TRO utilizando RECIST;
    •Supervivencia sin que progrese la enfermedad (SLP);
    •Duración de la respuesta.
    Otros objetivos secundarios adicionales son evaluar o comparar el efecto de la amrubicina en comparación con topotecán en cuanto a lo siguiente:
    •Tiempo hasta la progresión del tumor (TPT);
    •Calidad de vida (evaluada utilizando EuroQol [EQ-5D] y la Escala de síntomas de cáncer de pulmón [LCSS]);
    •Seguridad
    •Farmacocinética (concentraciones en plasma y en sangre total)sólo en pacientes tratados con amrubicina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Diagnóstico histológico o citológico de CPM en el inicio del estudio según la clasificación histopatológica de la Asociación Internacional para el Estudio del Cáncer de Pulmón (IASLC). No se permitirán subtipos mezclados o combinados, de acuerdo con la IASLC;
    2.CPM que sea o bien sensible (definido como una respuesta a la quimioterapia con platino para el tratamiento de primera línea, con la consiguiente evolución ≥ 90 días tras completar la quimioterapia) o resistente al tratamiento (definido como una respuesta no objetiva al tratamiento previo con platino o una evolución < 90 tras completar el tratamiento previo con platino);
    3. Enfermedad diseminada o limitada; sin embargo, a los pacientes con enfermedad limitada que sean candidatos para la radioterapia de rescate regional o local se les ha tenido que ofrecer dicho tratamiento antes de participar en ese estudio;
    4. Una progresión documentada radiográficamente tras el tratamiento de primera línea con quimioterapia con platino;
    5. No más de un régimen de quimioterapia previo;
    6. Al menos 18 años de edad;
    7. Estado general según la escala ECOG (Eastern Cooperative Oncology Group) de 0, 1 ó 2
    8. Enfermedad medible definida por los criterios del RECIST modificados, como se indica a continuación:
    a. Enfermedad medible: La presencia de al menos 1 lesión medible
    b. Lesión medible: Lesiones que pueden ser medidas con precisión en, al menos, 1 dimensión con el diámetro más largo ≥ 20 mm, utilizando técnicas convencionales, o ≥ 10-16 mm, según el intervalo de reconstrucción, utilizando tomografías computarizadas (TC) espirales;
    9. Una función orgánica adecuada, incluyendo lo siguiente:
    a. Reserva adecuada de médula ósea: Recuento absoluto de neutrófilos (segmentados y bandas) (RAN) ≥ 1,5 x 109/L, recuento de plaquetas ≥ 100 x 109/L y hemoglobina ≥ 90 g/L,
    b.Hepática: Bilirrubina ≤ 1,5 x el límite superior normal (LSN), ALT y AST ≤ 3,0 x LSN,
    c. Renal: Creatinina sérica ≤ 1,5 x LSN o estimación del aclaramiento de creatinina > 60 mL/min
    d. Cardíaca: Fracción de eyección del ventrículo izquierdo (FEVI) ≥ el límite inferior normal institucional evaluada por ecocardiografía (ECHO) o ventriculografías nucleares (MUGA o VRN)
    10. Prueba serológica de embarazo negativa en el momento de la inscripción para mujeres con capacidad de procrear
    11. Para los hombres y mujeres con potencial reproductivo, uso de métodos anticonceptivos eficaces durante el estudio
    12. Capacidad de entender los requisitos del estudio, facilitar un consentimiento informado por escrito y una autorización de uso y divulgación de la información protegida sobre la salud, entender y completar los formularios de la CdV y estar de acuerdo en respetar las limitaciones del estudio y en devolver las evaluaciones requeridas.
    E.4Principal exclusion criteria
    Los pacientes que cumplan algunos de los siguientes criterios serán excluidos del estudio:
    1. Mujeres embarazadas o en período de lactancia
    2. Radioterapia del tórax con un intento curativo en el complejo principal de la enfermedad ≤ 28 días antes de la primera dosis; radioterapia craneal ≤ 21 días antes de la primera dosis; radioterapia en el resto de las zonas ≤ 7 días antes de la primera dosis
    3. Antes del tratamiento con antraciclina, topotecán o irinotecán
    4. Tratamiento con cualquier agente en fase de investigación clínica en un período de 28 días o quimioterapia estándar en un período de 21 días antes de la primera dosis. Los pacientes deben haberse recuperado de todos los efectos adversos graves de tratamientos anteriores, excluyendo la alopecia
    5. Pacientes con cáncer previo tratado con quimioteràpia y/o radioterapia (excepto el carcinoma del cuello uterino in situ, el cáncer de próstata localizado de escasa malignidad, el cáncer de piel no melanomatoso tratado de forma adecuada o el carcinoma ductal in situ [CDIS] de la mama). Los pacientes con cáncer previo que fue tratado quirúrgicamente al menos 3 años antes y que han presentado remisión desde entonces podrán participar en el estudio
    6. Enfermedad concomitante grave o no controlada (por ejemplo, infección sistémica activa, diabetes, hipertensión, enfermedad coronaria, insuficiencia cardíaca congestiva) que, en opinión del investigador, comprometerían la seguridad del paciente o la capacidad del paciente para finalizar el estudio
    7. Metástasis sintomática del sistema nervioso central. Los pacientes con metástasis cerebral asintomática pueden participar. El paciente debe estar estable durante ≥ 2 semanas tras la radioterapia; si el paciente está sometido a un tratamiento con corticosteroides, la dosis de corticosteroides tiene que haber sido estable durante ≥ 2 semanas antes de la primera dosis del tratamiento del estudio o estar reduciéndose poco a poco
    8. Sospecha de enfermedad pulmonar intersticial difusa idiopática o fibrosis pulmonar no relacionada a un tratamiento previo
    E.5 End points
    E.5.1Primary end point(s)
    Los datos de la supervivencia global
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del tratamiento se define como la fecha de la muerte del último paciente o pérdida de seguimiento de este.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years3
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=65 years) Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 480
    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)
    A todos los pts se les realizará seguim. hasta su muerte.Una vez se complete el tto y no haya prog. de la enfermedad,al pt se le realizará regularmente mediciones de tumor hasta observar progresión.Para todos los pts se recogerá de forma regular info. ref. a la calidad de vida ,ttos posteriores y supervivencia. Sin embargo,no hay restricciones en los tipos de tto s post. que el pt puede recibir.El pt podrá recibir cualquier tto standard que se realize habitualmente en el hospital.
    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 Decision2008-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-23
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