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    Summary
    EudraCT Number:2011-002424-41
    Sponsor's Protocol Code Number:OGX-427-02
    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:2011-10-28
    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 number2011-002424-41
    A.3Full title of the trial
    A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination with OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma

    Estudio fase 2, doble ciego y aleatorizado para comparar la
    gemcitabina y el cisplatino en combinación con OGX-427 o
    placebo en pacientes con carcinoma de células transicionales
    avanzado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The trial is designed to determine the efficacy of OGX-427 Vs placebo in combination with Gemcitabine and Cisplatin in patients with Urinary tract cancer.

    El estudio está diseñado para determinar la eficacia de OGX-427 vS placebo en combinación con Gemcitabina y Cisplatino en pacientes con cancer en tracto urinario
    A.4.1Sponsor's protocol code numberOGX-427-02
    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 SponsorOncoGenex Technologies 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 supportOncoGenex Technologies Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncoGenex Technologies Inc.
    B.5.2Functional name of contact pointMonica Krieger
    B.5.3 Address:
    B.5.3.1Street Address1522 217th Place SE, Suite 100
    B.5.3.2Town/ cityBothell, Washington
    B.5.3.3Post code98021
    B.5.3.4CountryUnited States
    B.5.4Telephone number1425686 1558
    B.5.5Fax number1425686 1600
    B.5.6E-mailMKrieger@oncogenex.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 OGX-427
    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 INNNot applicable
    D.3.9.1CAS number 915443-09-3
    D.3.9.2Current sponsor codeOGX-427
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic or locally inoperable, advanced (T4b, N2, N3 or M1) transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra, ureter and renal pelvis)
    Pacientes con carcinoma de células transicionales (CCT) avanzado (T4b, N2, N3 o M1)
    metastásico o localmente inoperable de las vías urinarias (vejiga, uretra y pelvis
    renal)
    E.1.1.1Medical condition in easily understood language
    Metastatic or locally inoperable, advanced Urinary tract cancer.
    Metastásico o localmente inoperable, avanzado en las vías urinarias
    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 10005084
    E.1.2Term Bladder transitional cell carcinoma
    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 ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.
    Comprobar si existen evidencias de una mayor supervivencia respecto al brazo control en tres comparaciones: Brazo con 600 mg de OGX-427 y Brazo Control; Brazo con1000 mg de OGX-427 y Brazo control; y Brazos combinados con 600 mg y 1000 mg de OGX-427 y Brazo control.
    E.2.2Secondary objectives of the trial
    ?Comparar seguridad y tolerabilidad de placebo, 600 mg de OGX-427 y 1000 mg de OGX-427 combinado con gemcitabina y cisplatino.
    ?Seleccionar dosis óptima de OGX-427 (600 mg vs. 1000 mg) para estudios en Fase 3 en base a la seguridad y eficacia ( riesgo/beneficio).
    ?Comparar la TRG (RC+RP), tasa de control de enfermedad (RC+RP+enfermedad estable)duración de la respuesta y SLP entre brazos.
    ?Evaluar el efecto de la terapia con gemcitabina, cisplatino y OGX-427 sobre los valores séricos de Hsp27, de clusterina y cifras de CTC.
    ?Evaluar y comparar el número de células tumorales circulantes (CTC) en el inicio del estudio, la cifra mínima de CTC durante el tratamiento y el cambio máximo en la cifra de CTC en t entre brazos.
    ?Evaluar efecto administración repetida de OGX-427 sobre Cmax y Cmin mínimas de OGX-427 sericas.
    ?Evaluar la pérdida, translocación o deleción de PTEN, junto con genes dianas, en relación a la respuesta clínica y cambios en los niveles de clusterina y Hsp27.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age ≥ 18 years at the time of consent.
    2) Histologically documented metastatic or locally inoperable advanced TCC of the urinary tract (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3 or M1 disease).
    NOTE: Certain mixed histologies that are predominately (≥ 50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires IHC consistent with a TCC origin. Mixed small-cell histologies are excluded.
    3) Measurable disease defined as at least one target lesion that has not been irradiated and can be accurately measured in at least one dimension by RECIST 1.1 criteria.
    4) No prior systemic chemotherapy with the following exceptions:
    - Prior use of radiosensitizing single agent therapy is allowed.
    - Prior neoadjuvant and adjuvant systemic chemotherapy are permissible if the interval from the end of therapy to the diagnosis of metastatic disease is at least 12 months.
    5) Minimum of 21 days have elapsed since prior major surgery or radiation therapy, with recovery from any adverse events.
    6) Karnofsky performance status ≥70%.
    7) Required laboratory values at baseline:
    - ANC ≥ 1.5x10^9 cells/L
    - platelet count ≥ 125 x 10^9/L
    - Calculated creatinine clearance ≥60 mL/minute (by modified Cockcroft-Gault formula).
    - bilirubin ≥ 1.5 x ULN (≥ 2.5 x ULN if secondary to Gilbert's disease)
    - AST and ALT ≥ 3.0 x ULN
    8) If of child-bearing potential, willing to use contraceptive measures during and for 3 months after completion of therapy.
    9) willing to give written informed consent
    1) Edad ≥ 18 años en el momento del consentimiento.
    2) CCT avanzado metastásico o localmente inoperable demostrado histológicamente (estadíos T4b, N2, N3 o M1) de las vías urinarias (vejiga, uretra, uréter y pelvis renal).
    NOTA: Son aptas determinadas histologías mixtas redominantemente (≥ 50%) de CCT:
    escamosa, adenocarcinoma e indiferenciada. Las histologías mixtas indiferenciadas exigen una inmunohistoquímica (IHQ) compatible con un origen en CCT. Las histologías microcíticas
    mixtas están excluidas.
    3) Enfermedad medible definida como la presencia de al menos una lesión diana que no ha sido irradiada y que sea medible con precisión en al menos una dimensión según los criterios RECIST 1.1.
    4) Ausencia de quimioterapia sistémica previa, con las siguientes excepciones:
    - Se permite el uso previo de monoterapia radiosensibilizante.
    - La quimioterapia sistémica neoadyuvante y adyuvante es permisible si el intervalo de tiempo transcurrido desde el final del tratamiento hasta el diagnóstico de enfermedad metastásica es de al menos 12 meses.
    5) Han transcurrido un mínimo de 21 días desde una operación importante o radioterapia, con recuperación de cualquier acontecimiento adverso.
    6) Estado de rendimiento de Karnofsky ≥70%.
    7) Valores analíticos requeridos en el inicio del estudio:
    - CAN ≥ 1,5x109 células/L
    - Recuento de plaquetas ≥ 125 x 109/L
    - Aclaramiento de creatinina estimado ≥60 mL/minuto (según la fórmula modificada
    de Cockcroft-Gault). Ver Apartado
    - Bilirrubina ≥ 1,5 x LSN (≥ 2,5 x LSN si es secundario a enfermedad de Gilbert)
    - AST y ALT ≥ 3,0 x LSN
    8) Mujer en edad fértil, dispuesta a utilizar métodos anticonceptivos durante la terapia y al menos durante 3 meses después de la finalización de la terapia.
    9) Dispuesto/a a dar su consentimiento informado
    E.4Principal exclusion criteria
    1) A candidate for potential curative surgery or radiotherapy.
    2) Intravesical therapy within the last 3 months,
    3) Documented brain metastasis or carcinomatous meningitis, treated or untreated. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of CNS disease.
    4) Peripheral neuropathy ≥Grade 2.
    5) Known serious hypersensitivity to gemcitabine, cisplatin or carboplatin.
    6) Current serious, uncontrolled medical condition such as congestive heart failure, angina, hypertension, arrhythmia, diabetes mellitus, infection, etc. or any condition such as a psychiatric illness which in the opinion of the investigator would make the patient unacceptable for the protocol.
    7) Cerebrovascular accident, myocardial infarction or pulmonary embolus within 6 months of randomization.
    8) History of significant bleeding disorder or recent bleeding event within 3 months of randomization or currently receiving warfarin anticoagulation therapy
    9) Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.
    10) Pregnant or nursing (must have a negative serum or urine pregnancy test within 72 hours prior to randomization).
    11) Participating in a concurrent clinical trial of an experimental drug, vaccine or device. Participation in an observational study is allowed.
    1) Candidato para posible operación quirúrgica curativa o radioterapia.
    2) Terapia intravesical en los tres meses previos,
    3) Metástasis cerebral o meningitis carcinomatosa documentada, tratada o no tratada. NOTA:
    No se requiere imagen cerebral salvo que el paciente presente síntomas o signos clínicos de enfermedad del SNC.
    4) Neuropatía periférica ≥Grado 2.
    5) Hipersensibilidad grave conocida a gemcitabina, cisplatino o carboplatino.
    6) Afección actual grave no controlada como insuficiencia cardiaca congestiva, angina,
    hipertensión, arritmia, diabetes mellitus, infección, etc. o cualquier otra afección como enfermedad psiquiátrica que, a criterio del investigador, convertiría al paciente en no admisible para el protocolo.
    7) Accidente cerebrovascular, infarto de miocardio o embolia pulmonar en los 6 meses antes de la aleatorización 57
    8) Antecedentes de trastorno hemorrágico significativo o acontecimiento hemorrágico reciente en los 3 meses antes de la aleatorización o recibe en la actualidad tratamiento anticoagulante con warfarina
    9) Segundo cáncer activo (excepto cáncer cutáneo no melanomatoso): un cáncer secundario activo se define como la necesidad actual de tratamiento anticanceroso o probabilidad elevada (> 30%) de recidiva durante el estudio.
    10) Mujer embarazada o que esté dando de lactar (debe tener una prueba de embarazo en suero u orina negativa en las 72 horas previas a la aleatorización).
    11) Participación simultánea en un ensayo clínico con un fármaco, vacuna o dispositivo experimentales. Se permite la participación en un estudio observacional.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for each patient is overall survival time.
    La variable principal de eficacia para cada paciente es el tiempo global de supervivencia
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint for each patient is overall survival time measured as time from the date of randomization to the date of death from any cause. For patients still alive at the time of analysis, overall survival time will be censored on the date of last contact.
    La variable principal de eficacia para cada paciente es el tiempo global de supervivencia
    medido como el tiempo desde la fecha de aleatorización hasta la fecha de la muerte por
    cualquier causa. Para los pacientes aún con vida en el momento del análisis, el tiempo
    global de supervivencia será censurado a la fecha del último contacto.
    E.5.2Secondary end point(s)
    The secondary efficacy objectives include evaluating the following:
    - Best response to therapy (CR, PR, SD, PD) will be summarized by treatment arm. In addition, the number (%) of patients with an overall response (CR or PR) and with disease control (PR or CR or SD) will be reported. Duration of responses will also be summarized.
    - Progression-free survival time (PFS) will be summarized by treatment arm. PFS is defined as the time from randomization to the date of disease progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.
    - Serum Hsp27 levels, serum clusterin levels and CTC counts will be summarized by treatment arm.
    - Serum OGX-427 Cmax and trough levels will be summarized by treatment arm.
    Los objetivos secundarios de eficacia incluyen la evaluación de lo siguiente:
    - Se elaborará un resumen con la mejor respuesta a la terapia (RC, RP, EE, PE) por
    brazo de tratamiento. Además, se notificará el número (%) de pacientes con
    respuesta global (RC o RP) y con control de la enfermedad (RP o RC o EE).
    También se proporcionará un resumen de la duración de las respuestas.
    - Se elaborará un resumen del tiempo de supervivencia libre de progresión (SLP) por
    brazo de tratamiento. SLP es definida como el tiempo desde la aleatorización hasta
    la fecha de la progresión de la enfermedad o la muerte, lo que ocurra primero, antes
    o después de la interrupción del tratamiento. Para aquellos pacientes aún en el
    estudio y aquellos aún con vida y que no presentan progresión una vez interrumpido el tratamiento, la SLP será censurada en la fecha de la última
    evaluación del tumor.
    - Se elaborará un resumen de los niveles de Hsp27 en suero, niveles de clusterina en
    suero y recuentos de CTC por brazo de tratamiento.
    - Se elaborará un resumen de los niveles Cmax y concentración mínima de OGX-427
    en suero por brazo de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time from the date of randomization to the date of death from any cause or the date of last contact for alive patients.
    Tiempo global de supervivencia medido como el tiempo desde la fecha de aleatorización hasta la fecha de la muerte por cualquier causa.
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Canada
    France
    Germany
    Italy
    Poland
    Spain
    United States
    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
    Last visit of the last subject (LVLS)
    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 months6
    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 months6
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 180
    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)
    All the patients will receive the local standard of care for their condition after their participation in the trial
    Todos los paciente recibiran los cuidados según sus locales standar según su situación despues de su participación en el Ensayo
    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 Decision2012-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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