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    Summary
    EudraCT Number:2011-000051-16
    Sponsor's Protocol Code Number:JX594-HEP018
    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:2011-11-22
    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 number2011-000051-16
    A.3Full title of the trial
    A Phase 2b Randomized Open-Label Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients with Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment.
    Ensayo de fase 2b, aleatorizado, abierto de JX-594 (virus Vaccinia con TK inactivada y que expresa GM-CSF) incorporado a los mejores cuidados paliativos frente a los mejores cuidados paliativos en pacientes con carcinoma hepatocelular avanzado que no han respondido al tratamiento con Sorafenib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b Study of Recombinant Vaccinia Virus to Treat Advanced Liver Cancer
    Ensayo de fase 2b de virus Vaccinia recombinante para el tratamiento de cáncer de hígado avanzado
    A.3.2Name or abbreviated title of the trial where available
    TRAVERSE
    A.4.1Sponsor's protocol code numberJX594-HEP018
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01387555
    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 SponsorJennerex, 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 supportTransgene S.A.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTransgene S.A.
    B.5.2Functional name of contact pointMedical Affairs Secretariat
    B.5.3 Address:
    B.5.3.1Street AddressBoulevard Gonthier d'Andernach, Parc d'Innovation CS80166
    B.5.3.2Town/ cityIllkirch-Graffenstaden cedex
    B.5.3.3Post code67405
    B.5.3.4CountryFrance
    B.5.4Telephone number+33388279155
    B.5.5Fax number+33388279141
    B.5.6E-mailclinical.trials@transgene.fr
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/700
    D.3 Description of the IMP
    D.3.1Product nameJX-594
    D.3.2Product code JX-594
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratumoral use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeJX-594
    D.3.9.3Other descriptive nameRecombinant Vaccinia GM-CSF; RAC VAC GM-CSF (Thymidine kinase-deactivated plus GM-CSF)
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Yes
    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) Yes
    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 Yes
    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
    Advanced hepatocellular carcinoma
    Carcinoma hepatocelular avanzado
    E.1.1.1Medical condition in easily understood language
    Advanced liver cancer
    Cáncer de hígado avanzado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine and compare overall survival (OS) for patients receiving JX-594 plus best supportive care (BSC) (Arm A) versus those receiving BSC (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.
    Determinar y comparar la supervivencia global para los pacientes que reciben JX-594 además de los mejores cuidados paliativos (MCP) (grupo A) frente a los que reciben los MCP (grupo B) en pacientes con carcinoma hepatocelular (CHC) avanzado que no han respondido al tratamiento con sorafenib.
    E.2.2Secondary objectives of the trial
    - Determine and compare time-to-tumor-progression (TTP) for Arm A versus Arm B based on modified RECIST (mRECIST) for HCC.
    - Determine the response rate for Arm A compared with Arm B based on mRECIST for HCC.
    - Determine time-to-symptomatic progression (TSP) for Arm A compared with Arm B.
    - Determine the Quality of Life (QoL) of patients treated in Arm A compared with Arm B.
    - Determine the safety and tolerability of JX-594 plus BSC (Arm A) compared to BSC (Arm B).
    - Determinar y comparar el tiempo hasta la progresión tumoral (TPT) para el grupo A frente al grupo B basándose en los criterios para la evaluación de la respuesta en tumores sólidos ?RECIST? modificados (mRECIST) para CHC.
    - Determinar la tasa de respuesta para el grupo A en comparación con el grupo B basándose en mRECIST para CHC.
    - Determinar el tiempo hasta la progresión sintomática (TPS) para el grupo A en comparación con el grupo B.
    - Determinar la calidad de vida (CdV) de los pacientes tratados en el grupo A en comparación con el grupo B.
    - Determinar la seguridad y tolerabilidad de JX-594 además de los MCP (grupo A) en comparación con los MCP (grupo B).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Hospital staff exposure sub-study and JX-594 shedding sub-study, 2011-09-12, amdt 1.
    The objective of hospital staff exposure sub-study is to get an indication of unintentional exposure and/or infection of care-givers by JX-594. The objective of the shedding sub-study is to detect shedding of infectious product.
    Subestudio de exposición al virus JX-594 en el personal del hospital y subestudio de eliminación del virus JX-594, enmienda 1, 12-09-2011. El subestudio de exposición en el personal del hospital tiene como objetivo obtener una indicación para la exposición involuntaria y/o para la infección por el virus JX-594 en cuidadores. El subestudio de eliminación del virus tiene como objetivo detectar el estado de eliminación del producto infeccioso
    E.3Principal inclusion criteria
    - Advanced HCC: patients are not eligible for, or had disease progression after, local-regional therapy (e.g. surgery, TACE, RFA, ethanol injection)
    - Histologic or cytologic confirmation of primary hepatocellular carcinoma (HCC)
    - Previously treated with sorafenib for ? 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression
    - Received sorafenib as the most recent therapeutic intervention
    - ECOG performance status 0, 1 or 2
    ?Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
    - CHC en estadio avanzado: pacientes no elegibles para terapia local-regional (por ejemplo, cirugía, quimioembolización transarterial [QETA], ablación por radiofrecuencia [ARF], inyección de etanol), o que tras haberse sometido a la misma su enfermedad haya progresado.
    - Confirmación histológica o citológica de CHC primario.
    - Pacientes que han recibido previamente tratamiento con sorafenib durante ?14 días y que hayan interrumpido el tratamiento con sorafenib al menos 14 días antes de la aleatorización debido a intolerancia o progresión radiográfica.
    - Pacientes que han recibido sorafenib como la intervención terapéutica más reciente.
    - Estado funcional 0, 1 o 2 según la escala del Eastern Cooperative Oncology Group (ECOG).
    E.4Principal exclusion criteria
    - Major surgery within 28 days of randomization or subcutaneous venous access device placement within 7 days prior to randomization
    - Locoregional therapy within 28 days prior to randomization
    - Received sorafenib within 14 days prior to randomization
    - Received systemic therapy other than sorafenib within 28 days of randomization
    - Prior treatment with JX-594
    - Platelet count < 50,000 PLT/ mm3
    - Total white blood cell count < 2,000 cells/mm3
    - Hematocrit < 30% and/or Hemoglobin < 10 g/dL
    - Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication
    - Severe or unstable cardiac disease
    - Viable CNS malignancy associated with clinical symptoms
    - Pregnant or nursing an infant
    - Cirugía mayor en el plazo de 28 días desde la aleatorización o colocación de dispositivo subcutáneo de acceso venoso en los 7 días previos a la aleatorización.
    - Terapia local-regional en los 28 días previos a la aleatorización.
    - Haber recibido sorafenib en los 14 días previos a la aleatorización.
    - Haber recibido terapia sistémica diferente de sorafenib en los 28 días después de la aleatorización.
    - Haber recibido tratamiento previo con JX-594.
    - Recuento de plaquetas < 50.000 mm3
    - Recuento total de leucocitos < 2.000 células/mm3
    - Hematocrito < 30% y/o hemoglobina < 10 g/dl..
    - Inmunodeficiencia importante conocida debida a una enfermedad subyacente (por ejemplo, VIH/SIDA) y/o a medicamentos.
    - Enfermedad cardiaca grave o inestable.
    - Neoplasia viable del sistema nervioso central (SNC) asociada con síntomas clínicos.
    - Paciente embarazada o en período de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival
    Supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    CT scan every six weeks until progression or death
    TC cada seis semanas hasta la progresión o la muerte
    E.5.2Secondary end point(s)
    Time-to-tumor progression, tumor response, time-to-symptomatic-progression duration, change in quality of life, safety and toxicity.
    Tiempo hasta la progresión tumoral, respuesta tumoral, duración del tiempo hasta la progresión sintomática, cambio en la calidad de vida, seguridad y toxicidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Time to Tumor Progression: CT scan every six weeks until progression or death, assessed up to 21 months (average)
    - Quality of Life: assessed up to 21 months (average)
    - Tumor Response: CT scan every 6 weeks until progression or death, assessed up to 21 months (average)
    - Safety profile of JX594: assessed up to 21 months (average)
    - Time-to-symptomatic-progression: assessed up to 21 months (average)
    - Tiempo hasta la progresión tumoral: TC cada seis semanas hasta la progresión o la muerte, evaluado hasta 21 meses (promedio)
    - Calidad de vida: evaluado hasta 21 meses (promedio)
    - Respuesta tumoral:TC cada seis semanas hasta la progresión o la muerte, evaluado hasta 21 meses (promedio)
    - Profil de seguridad de JX594: evaluado hasta 21 meses (promedio)
    - Tiempo hasta la progresión sintomática: evaluado hasta 21 meses (promedio)
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Los mejores cuidados paliativos
    Best Supportive Care (BSC)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Canada
    Hong Kong
    Korea, Republic of
    Russian Federation
    Taiwan
    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
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months21
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months21
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 40
    F.4.2.2In the whole clinical trial 120
    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)
    Normal treatment of that condition
    Tratamiento habitual de esta enfermedad
    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 Decision2012-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-03
    P. End of Trial
    P.End of Trial StatusOngoing
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