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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-014591-21
    Sponsor's Protocol Code Number:H8K-MC-JZAO
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-10-26
    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 number2009-014591-21
    A.3Full title of the trial
    A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma
    A.4.1Sponsor's protocol code numberH8K-MC-JZAO
    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 SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 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 nameTasisulam Sodium
    D.3.2Product code LY573636
    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 INNtasisulam sodium
    D.3.9.1CAS number 519055-63-1
    D.3.9.2Current sponsor codeLY573636
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 1000
    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 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 PACLITAXEL TEVA 6 mg/ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA GENERICOS ESPAÑOLA, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Concentrate 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 INNPACLITAXEL
    D.3.9.3Other descriptive namePACLITAXEL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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
    Segunda linea Melanoma Metastasico
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    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 del estudio consiste en comparar la supervivencia global (SG) de los pacientes con melanoma metastásico que hayan recibido un tratamiento quimioterápico previo, basado en dacarbazina o temozolamida, cuando se les trata con tasisulam o con paclitaxel.
    E.2.2Secondary objectives of the trial
    - Comparar los siguientes puntos:
    • Variables temporales de eficacia:
    o Supervivencia libre de progresión.
    o Duración de la respuesta.
    o Reducción de la puntuación en el FACT-M
    • Tasa de respuestas tumorales objetivas.
    • Tasa de beneficio terapéutico.
    • Medidas relacionadas con la seguridad relativa.
    • Medidas de los resultados de salud.
    - Investigación aplicada:
    • Evaluar los efectos del estado mutacional de los genes BRAF y c-Kit.
    • Evaluar los efectos, específicos del tratamiento, de los marcadores genéticos, incluyendo, sin carácter restrictivo, los genes DMET
    • Evaluar de forma exploratoria otros biomarcadores relevantes.
    Evaluar de forma exploratoria la relacion de otros biomarcadores relevantes y el resultado clínico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [[1] Diagnóstico histológico y/o citológico de melanoma metastásico (estadio IV).
    [2] Presentar enfermedad evaluable, según se define en los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) (RECIST, versión 1.0).
    [3] Tener al menos 18 años de edad.
    [4] Categoría funcional de 0 a 1 en la Escala del Eastern Cooperative Oncology Group (ECOG) (véase el anexo JZAO.4).
    [5] Haber presentado progresión de la enfermedad tras la administración de 1 tratamiento sistémico previo para el melanoma metastásico, que incluyera dacarbazina o temozolamida.
    [6] Haber discontinuado todos los tratamientos antineoplásicos previos, entre los que se incluyen la quimioterapia, la radioterapia, la inmunoterapia, o cualquier otro tratamiento en fase de investigación, al menos durante los 30 días previos a la inclusión en el estudio (45 días en el caso de la mitomicina C o las nitrosoureas), y haberse recuperado de la toxicidad aguda del tratamiento (exceptuando la alopecia). En caso de radioterapia holocraneal, dicha irradiación deberá haberse completado 90 días antes de iniciar el tratamiento del estudio.
    [7] Tener una función orgánica adecuada, incluyendo los siguientes parámetros:
    • Reserva medular adecuada: Recuento absoluto de neutrófilos (RAN) previo al tratamiento >= 1,5 x 109/L, plaquetas >= 100 x 109/L y hemoglobina >= 8 g/dl (previamente al reclutamiento en el estudio, no se permite la realización de transfusiones para alcanzar dicho nivel de 8 g/dl).
    • Hepática: Bilirrubina <= 1,5 veces el límite superior normal (LSN). Valores de fosfatasa alcalina y transaminasas (ALT y AST) <= 5 veces el LSN.
    • Renal: Aclaramiento de creatinina igual o inferior al LSN. No presentar una enfermedad renal activa.
    [8] Concentración sérica de albúmina >= 3,0 g/dl >= 30 g/L).
    [9] Los hombres y mujeres en edad fértil deberán utilizar, durante el estudio y los 6 meses posteriores a la última dosis del fármaco del estudio, medidas anticonceptivas clínicamente aprobadas.
    [10] Las mujeres en edad fértil deberán presentar un resultado negativo en una prueba de embarazo en suero, realizada<= 7 días antes de la primera dosis del fármaco del estudio.
    [11] Cumplimiento terapéutico y proximidad geográfica que permitan un seguimiento adecuado.
    [12] Haber proporcionado su consentimiento informado por escrito, tanto para la investigación clínica como para la investigación aplicada, que deberá aprobar Lilly y el correspondiente Comité Ético del centro.
    [13] Firmar la autorización para utilizar una muestra almacenada de tejido tumoral para la detección de mutaciones en los genes BRAF y c-Kit. Aquellos pacientes que no dispongan de una muestra tumoral podrán ser reclutados en el estudio
    E.4Principal exclusion criteria
    [14] Estar participando en la actualidad o haber discontinuado en los últimos 30 días la participación en un ensayo clínico, en el que se administre un fármaco o se utilice un dispositivo en fase de investigación, para una indicación no recogida en la ficha técnica (excepto el fármaco del estudio), o estar participando en la actualidad en cualquier otro tipo de investigación médica que se considere que no es compatible con el estudio, desde un punto de vista científico o médico.
    [15] Haber recibido <=2 tratamientos sistémicos previos que contengan fármacos quimioterápicos, para tratar el melanoma metastásico. La inmunoterapia o los tratamientos basados en la administración de anticuerpos [incluyendo los tratamientos basados en la administración de fármacos biológicos o vacunas], así como las terapias dirigidas (por ejemplo, los inhibidores del gen BRAF o del gen c-Kit) no se consideran tratamientos previos a la hora de determinar la idoneidad de los pacientes para participar en el estudio, a menos que dichos tratamientos se hayan combinado con un citotóxico.
    [16] Administración previa de paclitaxel en monoterapia o de un tratamiento que contenga paclitaxel, como tratamiento para el melanoma metastásico.
    [17] Presentar, de forma documentada, metástasis activas en el sistema nervioso central (metástasis cerebrales) o leptomeníngeas en el momento de la inclusión en el estudio. Los pacientes con signos o síntomas de afectación neurológica deberán someterse a las correspondientes pruebas radiológicas antes de su inclusión en el estudio, para descartar posibles metástasis cerebrales ocultas. Los pacientes que presenten antecedentes de una única metástasis en el SNC, que haya sido tratada con fines curativos (por ejemplo, cirugía o radioterapia estereotáctica), y que no requieran el uso de esteroides, podrán ser incluidos en el estudio.
    [18] Presentar una enfermedad concomitante grave, entre las que se incluyen las infecciones bacterianas, fúngicas o víricas activas, incompatibles con el estudio (a criterio del investigador).
    [19] Presentar una segunda neoplasia que pudiera interferir con el cumplimiento del protocolo o la interpretación de los resultados. NOTA: Se considerarán pacientes idóneos para su inclusión en el estudio aquellos que presenten un carcinoma de piel (sin incluir el melanoma) que se haya tratado apropiadamente, y aquellos que, pese a tener antecedentes de otra neoplasia permanezcan libres de enfermedad durante más de 2 años.
    [20] Pacientes que presenten enfermedades preexistentes graves (según el criterio del investigador).
    [21] Estar recibiendo warfarina.
    [22] Haber completado o haber sido retirado previamente de este estudio o de cualquier otro donde se investigue tasisulam.
    [23] Presentar hipersensibilidad documentada a paclitaxel o Cremophor® EL (aceite de castor polioxietilado).
    [24] Mujeres embarazadas o en período de lactancia.
    [25] Presentar un melanoma primario ocular o de mucosas.
    [26] Haber recibido recientemente (en el transcurso de los 30 días previos al reclutamiento) o estar recibiendo de manera concurrente la vacuna contra la fiebre amarilla.
    [27] Presentar un resultado positivo en las pruebas de detección del virus de la inmunodeficiencia humana (VIH), el antígeno de superficie para la hepatitis B (HBSAg), o los anticuerpos contra el virus de la hepatitis C (HCAb).
    E.5 End points
    E.5.1Primary end point(s)
    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 No
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    segun protocolo
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 800
    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)
    segun protocolo
    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 Decision2010-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-02-10
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