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    Summary
    EudraCT Number:2011-003415-31
    Sponsor's Protocol Code Number:ARD12166
    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:2012-06-26
    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 number2011-003415-31
    A.3Full title of the trial
    Randomized Phase II Study of Cabazitaxel versus Topotecan in Small Cell Lung Cancer Patients with Progressive Disease during or after a First Line Platinum Based Chemotherapy
    Estudio fase II, aleatorizado, de Cabazitaxel versus Topotecan en pacientes con Cáncer de Pulmón de Células Pequeñas con Enfermedad Progresiva durante o después de una primera línea de quimioterapia basada en platino
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cabazitaxel compared to topotecan for the treatment of small cell lung cancer
    Cabazitaxel versus Topotecan para el tratamiento de Cáncer de Pulmón de Células Pequeñas
    A.4.1Sponsor's protocol code numberARD12166
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1123-3503
    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 SponsorSanofi-aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointCSU Director
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 5ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934859466
    B.5.5Fax number+34934895466
    B.5.6E-mailbibiana.figueres@sanofi.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 Yes
    D.2.1.1.1Trade name Jevtana
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis
    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 Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNCABAZITAXEL
    D.3.9.1CAS number 183133-96-2
    D.3.9.2Current sponsor codeXRP6258
    D.3.9.4EV Substance CodeSUB31282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.2.5The 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 Injection
    D.3.4.1Specific paediatric formulation No
    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 INNtopotecan
    D.3.9.1CAS number 119413-54-6
    D.3.9.3Other descriptive nameTOPOTECAN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04921MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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
    Small Cell Lung Cancer
    Cáncer de Pulmón de Células Pequeñas
    E.1.1.1Medical condition in easily understood language
    Small Cell Lung Cancer
    Cáncer de Pulmón de Células Pequeñas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10041071
    E.1.2Term Small cell lung cancer stage unspecified
    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 demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in patients with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.
    Demostrar la mejoría de la supervivencia libre de progresión (SLP) para cabazitaxel comparado con topotecán en pacientes con cáncer pulmonar de células pequeñas sensible o resistente/refractario después de una quimioterapia de primera línea basada en platino.
    E.2.2Secondary objectives of the trial
    o To assess disease progression free rate at 12 weeks
    o To assess Response Rate (RECIST 1.1) and duration of response
    o To assess Overall Survival (OS)
    o To assess the Safety (NCI-CTC version 4.03)
    o To assess the Health-Related Quality of Life (HRQoL)
    • Evaluar la tasa libre de progresión de la enfermedad a las 12 semanas
    • Evaluar la Tasa de Respuesta (RECIST 1.1) y la duración de la respuesta
    • Evaluar la Supervivencia Global (SG)
    • Evaluar la Seguridad (NCI-CTC versión 4.03)
    • Evaluar la Calidad de Vida Relacionada con la Salud (HRQoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I 01. Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy
    I 02. Male or female ?18 years (or country's legal age of majority if >18 years)
    I 03. Patients with measurable disease, RECIST (version 1.1)
    I 04. ECOG performance status ?1
    I 01. Cáncer pulmonar de células pequeñas metastático o localmente avanzado comprobado histológica/citológicamente con enfermedad progresiva durante o después de una primera línea de quimioterapia basada en platino.
    I 02. Hombre o mujer > 18 años (o la edad legal de mayoría de edad del país si > 18 años)
    I 03. Pacientes con enfermedad medible, RECIST (versión 1.1.)
    I 04. Estado funcional de ECOG <1
    E.4Principal exclusion criteria
    E 01. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study.
    E 02. More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes.
    E 03. Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization. (Radiotherapy for bone pain palliation is allowed).
    E 04. Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
    E 05. Uncontrolled CNS metastases: patients with CNS metastases may have previous irradiation, only patients with SD or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent can be included.
    E 06. Patients with known leptomeningeal metastases
    E 07. History of other, invasive neoplasm requiring ongoing therapy.
    E 08. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
    E 09. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
    E 10. Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results
    E 11. Known HIV disease, or active hepatitis B or C (systematic testing is not required).
    E 12. Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
    E 13. Patient with reproductive potential (M/F) who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" will be based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation.
    E 14. History of hypersensitivity to polysorbate 80
    E 15. Inadequate organ and bone marrow function as evidenced by:
    o Hemoglobin <9.0 g/dL
    o Absolute neutrophil count <1.5 x 10 exp9/L
    o Platelet count <100 x 10exp9/L
    o AST/SGOT and/or ALT/SGPT >2.5 x ULN
    o AP >2.5 x ULN. In case of liver metastases AP > 5 x ULN
    o Total bilirubin >1.0 x ULN
    o Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula, and creatinine clearance <60 mL/min will exclude the patient.
    Relacionados con la metodología:

    E 01. Ausencia del formulario de consentimiento informado del paciente firmado y fechado aprobado por el IRB/Comité ético antes de la inclusión en el estudio.

    E 02. Más de un régimen de quimioterapia previo. Tratamiento previo con topotecan o taxanos.

    E 03. Menos de 28 días transcurridos desde el
    tratamiento previo con quimioterapia, radioterapia o cirugía al momento de la randomización. (Está permitida la radioterapia para paliar el dolor óseo).

    E 04. Acontecimientos adversos (excluyendo alopecia) de cualquier terapia anticancerígena previa de grado > 1 (Criterios de Terminología Comunes del Instituto Nacional del Cáncer [NCI CTCAE] v4.03) en el momento de la randomización.

    E 05. Metástasis incontroladas del SNC: pacientes con metástasis del SNC pueden tener irradiación previa, sólo los
    pacientes con EE o respuesta a la irradiación que están sin síntomas en el SNC y con una dosis máxima de esteroides de dexametasona de 8 mg diarios o equivalente pueden ser incluidos.

    E 06. Pacientes con metástasis leptomeníngea conocida
    E 07. Antecedentes de otra neoplasia invasiva que requiera terapia en curso.

    E 08. Participación en otro estudio clínico y cualquier tratamiento concomitante con cualquier fármaco en investigación dentro de los 30 días previos a la randomización.

    E 09. Cualquiera de los siguientes dentro de 6 meses previos a la inclusión en el estudio: infarto de miocardio, angina de pecho grave/inestable, bypass de la arteria coronaria/periférica con injerto, insuficiencia cardíaca congestiva clase III o IV según la NYHA, accidente vascular cerebral o accidente isquémico transitorio.

    E 10. Cualquier condición médica crónica o aguda grave, que pudiera perjudicar la capacidad del paciente de participar en el estudio o interferir en la interpretación de los resultados del estudio

    E 11. Enfermedad HIV o hepatitis B o C activa conocida (no se requiere pruebas sistemáticas).

    E 12. Mujeres embarazadas o en periodo de lactancia.
    Test de embarazo positivo en suero o en orina previo a la randomización

    E 13. Pacientes en edad fértil (M/F) que no acepten usar un método anticonceptivo aceptado y efectivo durante el periodo de tratamiento del estudio y por al menos 6 meses después de finalizado el tratamiento del estudio. La definición de método efectivo de anticoncepción” se basará en el criterio del investigador. El método efectivo de anticoncepción deberá ser adaptado además a la regulación local.

    Relacionados con la quimioterapia:

    E 14. Antecedentes de hipersensibilidad al polisorbato 80

    E 15. Función inadecuada de la médula ósea y órganos según lo evidenciado por:
    • Hemoglobina < 9,0 g/dL
    • Recuento absoluto de neutrófilos < 1,5 x 109/L
    • Recuento de plaquetas < 100 x 109/L
    • AST/SGOT y/o ALT/SGPT > 2,5 x LSN
    • FA >2,5 x LSN. En caso de metástasis del hígado FA > 5 x LSN
    • Bilirrubina total > 1,0 x LSN
    • Creatinina Sérica > 1,5 x LSN. Si la creatinina es 1,0 – 1,5 x LSN, se calculará el aclaramiento de creatinina de acuerdo con la fórmula CKD-EPI y un aclaramiento de creatinina <60 mL/min. excluirá al paciente (ver Apéndice A para la fórmula de cálculo)
    E.5 End points
    E.5.1Primary end point(s)
    progression free survival
    Supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 24 months
    Hasta 24 meses
    E.5.2Secondary end point(s)
    Overall survival
    Supervivencia global
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 24 months
    Hasta 24 meses
    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 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Brazil
    Canada
    Chile
    France
    Germany
    Greece
    Hungary
    Italy
    Korea, Republic of
    Norway
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    United States
    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
    Not applicable
    No aplica
    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 months4
    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 months4
    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 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: 103
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 172
    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)
    Not applicable
    Not applicable
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-07
    P. End of Trial
    P.End of Trial StatusOngoing
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