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    Summary
    EudraCT Number:2007-001473-28
    Sponsor's Protocol Code Number:CPNM-PS2-07
    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:2007-05-22
    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 number2007-001473-28
    A.3Full title of the trial
    Ensayo clínico fase II de Gemcitabina y Docetaxel quincenal como tratamiento de 1ª línea para la enfermedad avanzada en pacientes con carcinoma no microcítico de pulmón y estado funcional ECOG 2
    A.4.1Sponsor's protocol code numberCPNM-PS2-07
    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 SponsorAsociación Terapéutica en Hematología y Oncología Médicas del Hospital Arnau de Vilanova de Valencia
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Taxotere
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis S.A.U
    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 Solution for injection
    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 INNDocetaxel
    D.3.9.1CAS number 114977-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 2
    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 Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderLilly. SA
    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 injection
    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 INNGemcitabina
    D.3.9.1CAS number 95058-81
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Carcinoma de Pulmón no microcítico (CPNM) avanzado o metastásico
    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
    -Determinar la tasa de respuestas de los pacientes con CPNM avanzado o metastásico tratados con docetaxel y gemcitabina en pauta quincenal
    E.2.2Secondary objectives of the trial
    -Evaluar la toxicidad de la pauta quincenal de docetaxel y gemcitabina.

    -Evaluar el tiempo hasta la progresión, duración de la respuesta y la supervivencia global.

    -Evaluar la calidad de vida de los pacientes según el cuestionario LCSS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Pacientes mayores de 18 años y menores de 70 años
    •Pacientes con diagnóstico citológico o histológico de CPNM avanzado (estadio III con derrame pleural y IV).
    •Al menos una lesión medible según criterios RECIST no irradiada previamente (lesiones medibles en al menos una dimensión, cuyo diámetro mayro sea > 20 mm con técnicas convencionales o > 10 mm con TAC helicoidal).
    •Estado general (PS) = 2, según la escala del Eastern Cooperative Oncology Group (ECOG)
    •Esperanza de vida de al menos 12 semanas
    •Función de la médula ósea adecuada (definida como neutrófilos mayor o igual a 2000/microlitors, leucocitos mayor o igual a 4000/microlitros, plaquetas mayor o igual a 100000/micro litros, hemoglobina mayor o igual 10 g/dl )
    •Ausencia de alteración hepática o renal severa (creatinina menor o igual a 2 mg/dl, AST y ALT menor o igual a 5 veces el límite superior de la normalidad, bilirrubina menor o igual 1,5 mg/dl, fosfatasa alcalina 5 veces el límite superior de la normalidad)
    •Pacientes que han otorgado su Consentimiento informado por escrito
    E.4Principal exclusion criteria
    •Pacientes que hayan recibido previamente quimioterapia para la enfermedad avanzada.
    •Metástasis cerebrales sintomáticas
    •Metástasis ósea no medible o derrame pleural maligno como única lesión metastásica.
    •Neuropatía periférica sensitiva o motora mayor o igual a 2 según Criterios de Toxicidad Común del NCI (NCI-CTCAE versión 3.0
    •Embarazo o lactancia
    •Historia de tumor maligno previo o concomitante (excepto carcinoma in situ de cérvix o carcinoma basocelular adecuadamente tratado), salvo aquellos con una supervivencia libre de enfermedad igual o superior a 5 años.
    •Mujeres embarazadas o en período de lactancia. Las mujeres fértiles (incluyendo aquellas con útero intacto y amenorrea de menos de 24 meses) deberán presentar una prueba de embarazo negativa (en suero u orina) en los 7 días anteriores al inicio del tratamiento. Asimismo, deberán utilizar métodos anticonceptivos eficaces (anticonceptivos orales, dispositivo intrauterino, métodos anticonceptivos de barrera, conjuntamente con gel espermicida, o esterilización quirúrgica) durante el estudio y hasta 6 meses tras la finalización del tratamiento.
    •Pacientes sometidos a procedimientos de cirugía mayor, biopsias abiertas o aquellos que hayan tenido lesiones traumáticas significativas dentro de los 28 días anteriores al comienzo del tratamiento del estudio, o pacientes en los que esté previsto un procedimiento de cirugía mayor que necesariamente tenga que realizarse durante el curso del estudio.
    •Cualquier otra enfermedad, alteración neurológica o metabólica, hallazgo de la exploración física o de laboratorio clínico que proporcione indicios razonables para sospechar una enfermedad o afección para la que está contraindicado el uso de alguno de los fármacos del estudio o que coloque al paciente en riesgo alto de experimentar complicaciones relacionadas con el tratamiento.
    •Tratamiento en la actualidad con otro fármaco en investigación o participación en otro estudio de investigación en los 30 días previos a la inclusión en el estudio.
    •Hipersensibilidad conocida a cualquiera de los fármacos del estudio o sus componentes.
    E.5 End points
    E.5.1Primary end point(s)
    Evidencia de progresión de enfermedad
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Cada 2 meses hasta la progresión de la enfermedad o inicio de terapia antineoplásica y posteriormente cada 4 meses hasta 2 años de seguimiento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state76
    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 Decision2007-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
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