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    Summary
    EudraCT Number:2007-001421-10
    Sponsor's Protocol Code Number:4783-08
    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:2008-02-21
    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 number2007-001421-10
    A.3Full title of the trial
    Ensayo de fase III aleatorizado y doble ciego de STA-4783 en combinación con paclitaxel frente a paclitaxel solo para el tratamiento de pacientes con melanoma metastásico en estadio IV no tratados previamente con quimioterapia

    A Randomized, Double-Blind, Phase III Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic Melanoma
    A.4.1Sponsor's protocol code number4783-08
    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 SponsorSynta Pharmaceuticals Corp.
    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 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.3.2Product code STA-4783
    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.3.9.1CAS number 488832-69-5
    D.3.9.2Current sponsor codeSTA-4783
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number266
    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 6 mg/ml concentrado para solución para infusión
    D.2.1.1.2Name of the Marketing Authorisation holderWyvern Medical Ltd
    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 namepaclitaxel
    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.3.9.1CAS number 33069-62-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    Melanoma metastásico en estadio IV

    Stage IV Metastatic Melanoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027480
    E.1.2Term Metastatic malignant melanoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal es evaluar la eficacia de STA 4783 combinado con paclitaxel en comparación con paclitaxel solo, basándose en la supervivencia sin progresión (SSP).
    E.2.2Secondary objectives of the trial
    Evaluar la supervivencia global (SG).
    Evaluar la tasa de respuestas objetivas (TRO).
    Evaluar la tasa de beneficio clínico (proporción de pacientes con RC, RP o EE durante 24 semanas como mínimo)
    Evaluar la duración de la respuesta objetiva
    Describir con detalle la seguridad de STA 4783 combinado con paclitaxel en comparación con paclitaxel solo
    Caracterizar mejor la farmacocinética de STA 4783 combinado con paclitaxel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Podrán participar en el estudio los pacientes que cumplan todos los criterios que se citan a continuación:
    1.Edad igual o superior a 18 años
    2.Si se trata de una mujer en edad fértil o de un varón, estar dispuesto a utilizar dos métodos anticonceptivos eficaces diferentes durante el tratamiento del estudio.
    3.Presentar un melanoma de origen cutáneo, confirmado por histología.
    4.Presentar melanoma en estadio IV.
    5.Estado funcional según el Eastern Cooperative Oncology Group (ECOG) ≤2
    6.Presentar enfermedad mensurable, según los RECIST modificados.
    7.Si el paciente ha recibido tratamiento sistémico previo, deberá presentar datos de enfermedad persistente o progresiva o incapacidad de tolerar el tratamiento previo debido a la toxicidad, en opinión del investigador.
    8.No podrán haber recibido quimioterapia citotóxica previa para el melanoma (p. ej., DTIC, carmustina, taxanos, inhibidores de los microtúbulos, perfusión hipertérmica aislada de una extremidad).
    9.No podrán haber recibido más de una pauta de inhibidores de la cinasa, inmunoterapia, terapia biológica, vacunas ni tratamiento experimental distinto de la quimioterapia para el melanoma.
    10.Deberá haber pasado un mínimo de 4 semanas entre la administración de la última dosis de inhibidores de la cinasa, inmunoterapia, terapia biológica, vacunas o tratamiento experimental distinto de la quimioterapia (excepto anticuerpos anti-CTLA4) y la administración de la primera dosis de la medicación del estudio.
    11.Deberá haber pasado un mínimo de 8 semanas entre la administración de la última dosis de anticuerpos anti-CTLA4 y la administración de la primera dosis de la medicación del estudio.
    12.Deberá haber pasado un mínimo de 2 semanas entre la última administración de radioterapia y la administración de la primera dosis de la medicación del estudio.
    13.Deberán tener una esperanza de vida superior a 12 semanas.
    14.Deberán presentar los valores analíticos siguientes en la selección:
    •LDH ≤2,0 x LSN
    •Hemoglobina > ó = 8 g/dl (unidades SI: > ó = 80 g/l)
    •Recuento absoluto de neutrófilos > ó = 1.500/mm3 (unidades SI: > ó = 1.500 GI/l)
    •Recuento de plaquetas > ó = 100.000/mm3 (unidades SI: > ó = 100.000 GI/l)
    •Creatinina ≤ 1,5 mg/dl (unidades SI: ≤ 137 µmol/l) (NOTA: Si la creatinina es >1,5 mg/dl, el paciente podrá participar si el aclaramiento de creatinina es > ó = 60 ml/min utilizando la ecuación de Cockcroft Gault).
    •Bilirrubina total ≤ 1,2 mg/dl (unidades SI: ≤ 26 µmol/l).
    •Aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) y fosfatasa alcalina (FA) ≤2,5 x LSN
    15.Deberán presentar capacidad para comprender un consentimiento informado por escrito y deseo de firmarlo.
    E.4Principal exclusion criteria
    No podrán participar en el estudio los pacientes que cumplan cualquiera de los criterios que se citan a continuación:
    1. Pacientes embarazadas o lactantes.
    2. Presencia o antecedentes (> ó = 5 años) de otro tumor maligno que no sea un cáncer cutáneo distinto del melanoma ni un carcinoma cervicouterino in situ.
    3. Presencia de infección activa que requiera antibióticos por vía intravenosa, infección local grave (p. ej., celulitis, absceso) o infección sistémica (p. ej., neumonía, septicemia) que hayan requerido tratamiento sistémico con antibióticos en las 2 semanas previas a la administración de la primera dosis de la medicación del estudio.
    4. Presencia de neuropatía periférica potencialmente inducida por fármacos y que sea de grado 2 o superior según la versión 3.0 de los CTCAE del NCI.
    5. Antecedentes o síntomas clínicos de metástasis en el sistema nervioso central.
    6. Presencia de metástasis cerebrales (determinadas por tomografía computarizada [TC] con contraste o resonancia magnética [RM] realizadas en la selección).
    7. Presencia de arritmias cardíacas clínicamente significativas.
    8. Pacientes VIH positivos.
    9. Necesidad de tratamiento inmunosupresor crónico (p. ej., ciclosporina después de un trasplante).
    10. Haber sido operado en las dos semanas previas (1 semana si se trata de una intervención sin importancia, p. ej., las que sólo requieren anestesia local) a la administración de la primera dosis de la medicación del estudio.
    11. Uso de tratamiento contra el cáncer “complementario” (adquirido con o sin receta, incluidos los productos de herbolario o los antioxidantes en dosis elevadas) en las dos semanas previas a la administración de la primera dosis de la medicación del estudio y durante todo el estudio.
    12. Presencia de enfermedad concurrente grave o de otra situación (p. ej., circunstancias psicológicas, familiares, sociales o geográficas) que impidan realizar un seguimiento adecuado y cumplir el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal de eficacia es la supervivencia sin progresión (SSP).
    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 Yes
    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) 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 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) 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 EEA75
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 275
    F.4.2.2In the whole clinical trial 630
    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 Decision2008-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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