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    Summary
    EudraCT Number:2014-005696-93
    Sponsor's Protocol Code Number:ACT14205
    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:2015-03-27
    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 number2014-005696-93
    A.3Full title of the trial
    Phase II, Open Label, Single Arm Study Assessing the Clinical Benefit of SAR125844, Administered as Single Agent by Weekly Intravenous (IV) Infusion, for the Treatment of Patients with Advanced Pretreated Non-Small Cell Lung Cancer (NSCLC) Harboring MET Gene Amplification
    Estudio en fase II, abierto, de un único brazo para evaluar el beneficio clínico de SAR125844, administrado en monoterapia por infusión intravenosa (iv) semanal, para el tratamiento de pacientes con Cáncer de Pulmón No Microcítico (CPNM) avanzado y pretratado que albergan la amplificación del gen MET
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients with MET Amplification
    Estudio fase II para evaluar la eficacia y seguridad del SAR125844 en pacientes con Cáncer de Pulmón No Microcítico (CPNM) avanzado con la amplificación del gen MET
    A.4.1Sponsor's protocol code numberACT14205
    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 pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@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 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 SAR125844
    D.3.4Pharmaceutical form 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 INNNA
    D.3.9.1CAS number 1116743-46-4
    D.3.9.2Current sponsor codeSAR125844
    D.3.9.4EV Substance CodeSUB88508
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Neoplasm malignant
    Cáncer maligno
    E.1.1.1Medical condition in easily understood language
    Neoplasm malignant
    Cáncer maligno
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10028997
    E.1.2Term Neoplasm malignant
    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 determine objective response rate (ORR).
    Determinar la Tasa de Respuesta Objetiva (TRO)
    E.2.2Secondary objectives of the trial
    To assess duration of response (DR), progression free survival (PFS) and overall survival (OS).
    To evaluate global safety profile.
    To determine pharmacokinetic profile.
    To assess clinical utility of fluorescence in situ hybridization (FISH) assay in selection of patients with mesenchymal-epithelial hybridization (MET) gene amplifcation.
    To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.
    Evaluar la duración de la respuesta (DR), la supervivencia libre de progresión (SLP) y la supervivencia global (SG).
    Evaluar el perfil de seguridad de SAR125844.
    Determinar el perfil farmacocinético (FC) de SAR125844
    Evaluar la utilidad clínica del análisis por Hibridación Fluorescente In Situ (Fluorescence In Situ Hybridization, FISH) para la selección de pacientes con amplificación en el gen MET.
    Evaluar los síntomas específicos del carcinoma de pulmón, la calidad de vida relacionada con la salud (CVRS) y la satisfacción con el tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Metastatic non-small-cell lung cancer patients with progressive disease during or after first or second line therapy harboring MET gene amplification and with measurable disease by
    Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
    Cáncer de Pulmón No Microcítico metastásico con enfermedad progresiva durante o después del tratamiento de primera o segunda línea con amplificación en el gen MET
    Paciente con enfermedad medible, conforme a los criterios RECIST
    E.4Principal exclusion criteria
    Patient less than 18 years old.
    Eastern Cooperative Oncology Group (ECOG) performance status >2.
    More than 2 episodes of disease progression under anticancer therapy.
    Wash out period of less than 3 weeks from prior treatment with chemotherapy, radiotherapy or, surgery or any investigational treatment.
    Adequate hematologic, hepatic, renal, coagulation, and metabolic functions.
    No resolution of any specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to grade ?1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03.
    Pregnant or breast-feeding women.
    Patient with reproductive potential without method of contraception.
    Symptomatic brain metastasis.
    Any clinically significant medical condition other than cancer which could interfere with the safe delivery of study treatment or risk of toxicity.
    Known hypersensitivity or any adverse event related to the study drug excipient (Captisol®).
    Prior treatment with any MET Tyrosine Kinase Inhibitors (TKIs) or anti-MET antibodies (excluding onartuzumab).
    Patients treated with potent CYP3A inhibitor unless it can be discontinued.
    Patients treated with potent and moderate CYP3A inducers unless it can be discontinued.
    Mean QTc interval prolongation >470 msec.
    Paciente menor de 18 años
    Estado funcional > 2 conforme a la escala del Grupo Oncológico Cooperativo de la Costa Este de EE. UU. (ECOG)
    Más de 2 episodios de progresión de la enfermedad durante un tratamiento antineoplásico previo
    Paciente con un periodo de lavado farmacológico inferior a 3 semanas desde el tratamiento anterior con quimioterapia, radioterapia, cirugía o cualquier tratamiento en investigación.
    Función hepática o renal deficientes
    Toxicidad específica sin resolver (excluida la alopecia) relacionada con algún tratamiento antineoplásico anterior de grado ? 1, de acuerdo con los Criterios Terminológicos Comunes para Acontecimientos Adversos (CTCAE) del Instituto Nacional del Cáncer (National Cancer Institute, NCI) de EE. UU.(NCI-CTCAE v.4.03
    Mujeres embarazadas o en periodo de lactancia
    Paciente en edad fértil (tanto varón como mujer) que no esté de acuerdo en utilizar un método anticonceptivo eficaz aceptado
    Metástasis cerebral sintomática.
    Cualquier enfermedad grave activa o comorbilidad que, a criterio del Investigador, pueda interferir con la seguridad o el cumplimiento del estudio
    Hipersensibilidad conocida o acontecimientos adversos relacionados con el excipiente del fármaco experimental (Captisol®).
    Tratamiento previo con Inhibidores de la Tirosina Cinasa (ITC) del MET o con anticuerpos anti-MET (excepto onartuzumab).
    Pacientes tratados con inhibidores potentes de la CYP3A, a menos que se puedan discontinuar, como mínimo, 2 semanas antes del tratamiento del estudio o 5 semividas de eliminación, lo que sea más tiempo
    Pacientes tratados con inductores potentes y moderados de la CYP3A, a menos que se puedan discontinuar
    Promedio del intervalo QTc > 470 ms
    E.5 End points
    E.5.1Primary end point(s)
    Determination of the objective response rate of SAR125844 as per RECIST 1.1
    Determinación de la Tasa de Respuesta Objetiva de SAR125844 de acuerdo con los criterios RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 6 weeks up to disease progression
    Cada 6 semanas hasta la progresión de la enfermedad
    E.5.2Secondary end point(s)
    Progression-free survival rate
    Overall survival rate

    Proportion of patients with adverse events

    Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax)
    Assessment of pharmacokinetic parameters: area under curve (AUC)
    Assessment of pharmacokinetic parameters: total clearance (CL)
    Assessment of pharmacokinetic parameters: half-life (t1/2)

    Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13
    Assessment of health-related quality of life by QLQ-C30/LC13

    Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire
    Supervivencia libre de progresión (SLP)
    Supervivencia global (SG)

    Porcentaje de pacientes con Acontecimientos Adversos

    Parámetros farmacocinéticos: Cmáx, AUC, CL, Ve, t1/2

    Síntomas específicos del carcinoma de pulmón y CVRS, evaluados mediante el cuestionario QLQ-C30/LC-13

    Cuestionario sobre Satisfacción con el Tratamiento para el Cáncer
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 34 months
    Progression-free survival rate
    Overall survival rate

    Up to 40 months
    Proportion of patients with adverse events

    Up to 3 days
    Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax)
    Assessment of pharmacokinetic parameters: area under curve (AUC)
    Assessment of pharmacokinetic parameters: total clearance (CL)
    Assessment of pharmacokinetic parameters: half-life (t1/2)

    Every 3 weeks up to 34 months
    Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13
    Assessment of health-related quality of life by QLQ-C30/LC13

    Every 6 weeks up to 34 months
    Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire
    A LOS 34 MESES
    Supervivencia libre de progresión (SLP)
    Supervivencia global (SG)
    A LOS 40 MESES
    Porcentaje de pacientes con Acontecimientos Adversos
    A LOS 3 DÍAS
    Parámetros farmacocinéticos: Cmáx, AUC, CL, Ve, t1/2
    CADA 3 SEMANAS HASTA LOS 34 MESES
    Síntomas específicos del carcinoma de pulmón y CVRS, evaluados mediante el cuestionario QLQ-C30/LC-13
    CADA 6 SEMANAS HASTA LOS 34 MESES
    Cuestionario sobre Satisfacción con el Tratamiento para el Cáncer
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Lung Cancer symptoms, health-related quality of life, and treatment satisfaction
    Síntomas del cáncer de pulmón, calidad de vida, y satisfacción del tratamiento
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Turkey
    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
    LVLS
    Última visita del último paciente
    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 months7
    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 months7
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 140
    F.4.2.2In the whole clinical trial 168
    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)
    None
    Ninguno
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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