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    Summary
    EudraCT Number:2012-005776-34
    Sponsor's Protocol Code Number:GO28609
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-11
    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 number2012-005776-34
    A.3Full title of the trial
    A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE II TRIAL EVALUATING THE SAFETY AND ACTIVITY OF DNIB0600A COMPARED TO PEGYLATED LIPOSOMAL DOXORUBICIN ADMINISTERED INTRAVENOUSLY TO PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER.
    ENSAYO DE FASE II, ALEATORIZADO, ABIERTO Y MULTICÉNTRICO PARA EVALUAR LA SEGURIDAD Y LA ACTIVIDAD DE DNIB0600A EN COMPARACIÓN CON
    DOXORUBICINA LIPOSÓMICA PEGILADA, ADMINISTRADOS POR VÍA INTRAVENOSA A PACIENTES CON CÁNCER DE OVARIO RESISTENTE AL PLATINO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized study of the safety and efficacy of a novel drug, DNIB0600A, compared to chemotherapy when given intravenously to patients with ovarian cancer.
    ENSAYO ALEATORIZADO PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE UN NUEVO MEDICAMENTO, DNIB0600A, COMPARADO CON QUIMIOTERAPIA POR VÍA INTRAVENOSA A PACIENTES CON CÁNCER DE OVARIO.
    A.4.1Sponsor's protocol code numberGO28609
    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 SponsorRoche Farma, S.A en nombre de Genentech, Inc.
    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 supportGenentech Inc. c/o F. Hoffmann La Roche Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.6E-mailglobal.rochegenentechtrials@roche.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.3.1Product nameDNIB0600A
    D.3.2Product code RO5541081/F01-01
    D.3.4Pharmaceutical form Concentrate 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 INNDNIB0600A
    D.3.9.1CAS number 1401812-88-1
    D.3.9.2Current sponsor codeRO5541081
    D.3.9.3Other descriptive nameanti-NaPI2b
    D.3.9.4EV Substance CodeSUB33393
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    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 Yes
    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 doxorubicin hydrochloride (Caelyx)
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV, Belgium
    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 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 INNDoxorubicin
    D.3.9.1CAS number 23214-92-8
    D.3.9.3Other descriptive nameCaelyx, Doxil, Myocet
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    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.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
    Platinum Resistant Ovarian Cancer
    Cáncer de Ovario resistente al platino
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cáncer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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 evaluate the efficacy of DNIB0600A compared with pegylated liposomal doxorubicin (PLD) in patients with PROC as assessed by PFS in patients with NaPi2b-high tumors as well as in the overall patient population.
    Evaluar la eficacia de DNIB0600A en comparación con DLP en pacientes con CORP, según lo determinado mediante la SSP evaluada por el investigador, en pacientes con tumores con NaPi2b elevado, así como en la población total de pacientes.
    E.2.2Secondary objectives of the trial
    ?To evaluate the efficacy of DNIB0600A compared with PLD in patients with PROC as assessed by overall survival (OS) in patients with NaPi2b-high tumors as well as in the overall patient population
    ?To evaluate the anti-tumor activity of DNIB0600A compared with PLD in patients with PROC as assessed by overall response rates and duration of response in patients with NaPi2b-high tumors as well as in the overall patient population
    ?To evaluate the safety and tolerability of DNIB0600A compared with PLD in patients with PROC
    - Evaluar la eficacia de DNIB0600A en comparación con DLP en pacientes con CORP, según lo determinado mediante la SG en pacientes con tumores con NaPi2b elevado, así como en la población total de pacientes.
    - Evaluar la actividad antitumoral de DNIB0600A en comparación con DLP en pacientes con CORP, según lo determinado mediante las tasas de respuesta global y la duración de la respuesta en pacientes con tumores con NaPi2b elevado, así como en la población total de pacientes.
    - Evaluar la seguridad y la tolerabilidad de DNIB0600A en comparación con DLP en pacientes con CORP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Signed informed consent form
    ? Age ? 18 years
    ? Life expectancy of at least 12 weeks
    ? Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    ? Histological documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding carcinosarcoma histology)
    ? Availability and willingness to provide an adequate archival sample of tumor (paraffin tissue block or at least 15 unstained slides); if an archival tissue specimen is not available and a new tissue specimen is collected for diagnostic purposes for patient care, then fresh tissue may be submitted
    ? Advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed during or within 6 months after the most recent treatment with a platinum-containing chemotherapy regimen and for whom pegylated liposomal doxorubicin (PLD) is appropriate
    ? Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded ? 2.0 cm using conventional techniques or ? 1.0 cm on spiral computed tomography [CT] scan) per RECIST v1.1 criteria
    ? No more than one prior cytotoxic chemotherapy regimen for the treatment of PROC and no more than two total regimens (defined as any therapy [approved or investigational] with intent to treat the ovarian cancer)
    ? Absolute neutrophil count ? 1500/?L, hemoglobin ? 9 g/dL, and platelet count ? 100,000/?L
    ? Total bilirubin ? 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 ×ULN
    ? Serum creatinine ? 2.0 mg/dL
    - Documento de consentimiento informado firmado.
    - Edad ? 18 años.
    - Esperanza de vida de 12 semanas, como mínimo.
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1.
    - Confirmación histológica de un cáncer epitelial de ovario, cáncer peritoneal primario o cáncer de trompa de Falopio (excluida la histología de carcinosarcoma).
    - Disponibilidad y voluntad de proporcionar una muestra de archivo adecuada del tumor (bloque de tejido incluido en parafina o al menos 15 láminas sin teñir); cuando no se disponga de una muestra de tejido de archivo y se obtenga una nueva muestra de tejido con fines diagnósticos para la asistencia de la paciente, podrá enviarse tejido reciente.
    - Cáncer epitelial de ovario, peritoneal primario o de trompa de Falopio avanzado haya presentado progresión o recidiva en los 6 meses siguientes al tratamiento más reciente con un régimen de quimioterapia con platino y en el que DLP constituya un tratamiento adecuado.
    - Enfermedad mensurable con al menos una lesión que pueda medirse con exactitud en al menos una dimensión (dimensión más larga registrada ? 2,0 cm con técnicas convencionales o ? 1,0 cm en la tomografía computarizada [TC] helicoidal) según los criterios RECIST, versión 1.1.
    - No más de un régimen previo de quimioterapia citotóxica para tratar el CORP y no más de dos regímenes en total (definidos como cualquier tratamiento [aprobado o en investigación] con intención de tratar el cáncer de ovario).
    - Recuento absoluto de neutrófilos ? 1500/?l, hemoglobina ? 9 g/dl y recuento de plaquetas ? 100.000/?l.
    11. Bilirrubina total ? 1,5 veces el límite superior de la normalidad (LSN); valores de
    aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ? 2,5 veces el LSN.
    - Creatinina sérica ? 2,0 mg/dl.
    E.4Principal exclusion criteria
    Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, within 4 weeks prior to Day 1
    ? Palliative radiation within 2 weeks prior to Day 1
    ? Prior anthracycline therapy, including prior treatment with pegylated liposomal doxorubicin (PLD) (e.g., Doxil, Caelyx,? Prior treatment with NaPi2b or SCL34A2 targeted therapy
    ? Major surgical procedure within 4 weeks prior to Day 1
    ? Current Grade > 1 toxicity (except alopecia and anorexia) from prior therapy or Grade > 1 neuropathy from any cause
    ? Left ventricular ejection fraction (LVEF) defined by MUGA/ECHO below the institutional lower limit of normal (LLN)
    ? Evidence of significant, uncontrolled, concomitant disease which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease, history of bronchospasm, or any ongoing requirement for supplemental oxygen)
    - Tratamiento antitumoral, incluida quimioterapia y tratamiento biológico, experimental u hormonal, en las 4 semanas previas al día 1.
    - Radioterapia paliativa en las 2 semanas previas al día 1.
    - Tratamiento previo con antraciclinas, incluido el tratamiento previo con DLP (por ejemplo, Doxil, Caelyx)
    - Tratamiento previo con una terapia dirigada contra NaPi2b o SCL34A2.
    - Intervención de cirugía mayor en las 4 semanas previas al día 1.
    - Toxicidad presente de grado > 1 (excepto alopecia y anorexia) por el tratamiento previo o neuropatía de grado > 1 por cualquier causa.
    - Fracción de eyección del ventrículo izquierdo (FEVI) definida mediante ventriculografía isotópica en equilibrio (MUGA) o ecocardiograma por debajo del límite inferior de la normalidad (LIN).
    - Datos de enfermedades concomitantes, importantes y no controladas que puedan afectar al cumplimiento del protocolo o la interpretación de los resultados, entre ellas, enfermedades cardiovasculares importantes (como cardiopatía en clase III o IV de la New York Heart Association, insuficiencia cardíaca congestiva, infarto de miocardio en los 6 últimos meses, arritmias inestables o angina de pecho inestable) o enfermedades
    pulmonares importantes (como enfermedad pulmonar obstructiva, antecedentes de broncoespasmo o necesidad persistente de oxígeno suplementario).
    E.5 End points
    E.5.1Primary end point(s)
    Investigator-assessed progression-free survival (PFS) in patients with NaPi2b-high tumors as well as in all patients
    Supervivencia sin progresión (SSP) evaluada por el investigador en pacientes con tumores con NaPi2b elevado, así como en la población total de pacientes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening and every 8 weeks until discontinuation of the study treatment
    Evaluaciones de la respuesta cada 8 semanas hasta la discontinuación del tratamiento.
    E.5.2Secondary end point(s)
    -Overall survival (OS) in patients with NaPi2b-high tumors as well as in all patients
    -Investigator-assessed overall response rate (ORR) in patients with NaPi2b-high tumors as well as in all patients
    -Safety and tolerability
    - Supervivencia global en pacientes con tumores con NaPi2b elevado, así como en la población total de pacientes.
    - Supervivencia sin progresión, evaluada por el investigador en pacientes con tumores con NaPi2b elevado, así como en la población total de pacientes.
    - Seguridad y tolerabilidad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Throughout the study treatment and every 3 months until death, loss to follow-up, or study closure
    -Screening and every 8 weeks until discontinuation of the study treatment
    -Throughout the study treatment until 30 days after the last dose of either DNIB0600A or PLD
    - Durante el tratamiento del estudio y cada 3 meses hasta que se produzca la muerte, pérdida para el seguimiento o suspensión del estudio.
    - Evaluaciones de la respuesta cada 8 semanas hasta la discontinuación del tratamiento.
    - Durante el tratamiento del estudio y hasta 30 días después de la última dosis de DNIB0600A o PLD.
    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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    multicentre and open-label study
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Belgium
    Canada
    France
    Poland
    Spain
    United Kingdom
    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
    The end of this study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later. LPLV is expected to occur 1 year after the last patient is enrolled.
    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 months2
    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 months2
    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: 92
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 92
    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)
    Currently, Roche does not have any plans to provide DNIB0600A or other study interventions to patients after the conclusion of the study or any earlier withdrawal. Patients who complete or withdraw from the study will be moved to appropriate treatment for Ovarian Cancer as determined by their doctor.
    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 Decision2014-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-17
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