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    Summary
    EudraCT Number:2012-000591-42
    Sponsor's Protocol Code Number:JX594-IV-HEP021
    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:2012-07-26
    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 number2012-000591-42
    A.3Full title of the trial
    A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients with Advanced Hepatocellular Carcinoma (HCC).
    Ensayo de fase 2, de un solo brazo, abierto, de JX-594 (virus Vaccinia con TK inactivada y que expresa GM-CSF) administrado por medio de infusiones intravenosas (IV) semanales en pacientes con carcinoma hepatocelular avanzado (HCC) sin tratamiento previo con Sorafenib.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study of recombinant vaccinia virus in Sorafenib-naïve patients with Advanced liver cancer.
    Ensayo de fase 2 de virus Vaccinia recombinante en pacientes con cáncer del hígado avanzado sin tratamiento previo con Sorafenib.
    A.4.1Sponsor's protocol code numberJX594-IV-HEP021
    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.3.2Product 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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1058624-46-6
    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), VACC 6.25.1
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/dose plaque forming unit(s)/dose
    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) 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) 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
    Càncer del 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 14.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine radiographic response rate (based on mRECIST for HCC and mChoi criteria).
    Determinar el índice de respuesta radiográfica (basado en criterios RECIST [mRECIST] modificados y Choi [mChoi] modificados) para el carcinoma hepatocelular (HCC).
    E.2.2Secondary objectives of the trial
    ? Determine the safety of JX 594 administered by multiple IV infusions in patients with advanced HCC
    ? Determine time-to-tumor progression (TTP) on JX 594 therapy according to mRECIST criteria for HCC
    ? Determine overall survival (OS)
    ? Determinar la seguridad del JX 594 administrado por múltiples infusiones intravenosas (IV) a pacientes de HCC avanzado
    ? Determinar el tiempo hasta la progresión tumoral (THP) con terapia JX 594 siguiendo los criterios mRECIST para el HCC
    ? Determinar la supervivencia global (SG)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Advanced HCC (excluding fibrolamellar carcinoma and hepatoblastoma): Patients are not eligible for, or had disease progression after, local-regional therapy (e.g., surgery, TACE, RFA, ethanol injection, e.g., BCLC Grade B or C [AASLD guidelines])
    2. Histological/cytological confirmation or clinical/laboratory diagnosis of primary HCC [clinical/laboratory diagnosis is defined according to the AASLD guidelines as the following:
    a. nodules larger than 2 cm in cirrhotic livers: with typical vascular features on a dynamic imaging technique (CT, contrast US or non-contrast MRI), or AFP >200 ng/ml;
    b. nodules between 1?2 cm in cirrhotic livers: with typical vascular features on 2 dynamic studies.]
    3. Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites
    4. Platelet count ?50,000 plts/mm3
    5. INR ?1.7
    6. Measurable tumor (at least one tumor with ?1 cm LD of contrast-enhancement during the arterial phase on CT scanning)
    7. Expected survival of approximately 12 weeks or longer
    8. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
    9. Aged ?18 years old
    10. WBC count ?2,000 cells/mm3 and ?50,000 cells/mm3
    11. Absolute neutrophil count (ANC) ?1,200 cells/mm3
    12. Lymphocytes ?500 cells/mm3
    13. Hemoglobin ?10 g/dL (correction with transfusion allowed)
    14. Adequate liver function (albumin ?2.8 g/dL, total bilirubin ?3 mg/dL; ALT, AST ?5 x ULN)
    15. Serum chemistries within normal limits or Grade 1 (excluding alkaline phosphatase)
    16. For patients who are sexually active: patient must be able and willing to abstain for a minimum of 15 days after each treatment and subsequently use barrier method during JX 594 treatment period and for at least 6 weeks after the last JX 594 treatment
    17. Written informed consent obtained from the patient
    1. HCC en estadio avanzado (excluyendo carcinoma fibrolamelar y hepatoblastoma): Pacientes que no son elegibles (o cuya enfermedad avanzó) para terapia local-regional (p. ej. Cirugía, quimioempolización transarterial [TACE], ablación por radiofrecuencias [RFA], inyección de etanol, p. ej., BCLC Grado B o C [conforme con guías de la American Association for the Study of Liver Diseases {AASLD}])
    2. Confirmación histológica/citológica o diagnóstico clínico/de laboratorio de HCC primario definido según las guías de la AASLD como:
    ? Nódulos superiores a 2 cm en hígados cirróticos con características vasculares típicas (hipervascularidad con vaciado en fase portal/venosa) según técnica dinámica de imagen (tomografía computada (CT), imagen de resonancia magnética [MRI]), con o sin contraste US o AFP >200 ng/ml;
    ? nódulos entre 1 y 2 cm en hígados cirróticos con características vasculares típicas en 2 estudios dinámicos.
    3. Clase A Child-Pugh; o Clase B7 Child-Pugh sin ascitis clínicamente significativos
    4. Recuento de plaquetas ?50,000 plts/mm3
    5. Ratio normalizado internacional (INR) ?1.7
    6. Tumor medible del hígado (al menos un tumor con diámetro mayor ?1 cm [LD] de mejora de contraste durante la fase arterial de escaneo CT)
    7. Supervivencia esperada de 12 o más semanas aproximadamente
    8. Estatus de desempeño Eastern Cooperative Oncology Group (ECOG) 0, 1, o 2
    9. Edad ?18 años
    10. Recuento de glóbulos blancos ?2,000 glóbulos/mm3 y ?50,000 glóbulos/mm3
    11. Recuento neutrófilos absoluto (ANC) ?1,200 células /mm3
    12. Linfocitos ?500 células /mm3
    13. Hemoglobina ?10 g/dL (corrección de transfusión permitida)
    14. Adecuada función hepática (albúmina ?2.8 g/dL, bilirrubina total ?3 mg/dL [51.3 µmol/L]; alanina aminotransferasa [ALT], aspartato transaminasa [AST] ?5 x límite superiorde normal [ULN])
    15. Química sérica dentro de límites normales (WNL) o Grado 1 (excluyendo fosfatasa alcalina)
    16. Para pacientes sexualmente activos ? el paciente debe poder y estar dispuesto a abstenerse durante un mínimo de 15 días después de cada tratamiento y posteriormente usar métodos de barrera durante el período de tratamiento con JX 594 y durante al menos las 6 semanas siguientes al último tratamiento con JX 594
    17. Formulario escrito de consentimiento firmado por el paciente
    E.4Principal exclusion criteria
    1. Serum creatinine >2.0 mg/dL and/or creatinine clearance is <60 mL/min according to Cockroft-Gault formula
    2. Significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or medication
    3. History of severe exfoliative skin condition
    4. Tumor(s) invading a major vascular structure
    5. Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
    6. Severe or unstable cardiac disease, including significant coronary artery disease within the preceding 12 months, unless well-controlled and on stable medical therapy for at least 3 months
    7. Viable central nervous system (CNS) malignancy associated with clinical symptoms
    8. Received sorafenib as previous treatment for HCC for more than 14 days
    9. Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas)
    10. Participation in any other research protocol involving an investigational medicinal product (IMP) within 2 months prior to first treatment
    11. Other medical condition or laboratory abnormality or active infection that in the judgment of the Principal Investigator may increase the risk associated with study participation or may interfere with interpretation of study results and/or otherwise make the patient inappropriate for entry into this study
    12. Use of interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose.
    13. Significant bleeding event within the last 12 months based on investigator assessment.
    14. Inability to receive IV iodinated contrast agents for CT scanning due to documented history of iodinated contrast allergy unless controlled by medical intervention
    15. Pregnant or nursing an infant
    16. Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
    17. Patient unable or unwilling to comply with the protocol requirements
    1. Creatinina sérica >2.0 mg/dL y/o aclaramiento de creatinina <60 mL/min según la fórmula de Cockroft-Gault
    2. Inmunodeficiencia significativa debida a enfermedad subyacente (p. ej., HIV/AIDS) y/o medicación
    3. Historia de enfermedad cutánea exfoliativa gave
    4. Tumor(es) que invadan una estructura vascular importante
    5. ascitis, efusiones pericardiales y/o pleurales clínicamente significativas y/o de acumulación rápida
    6. Enfermedad cardíaca grave o inestable, incluyendo enfermedad significativa de la arteria coronaria en los 12 meses anteriores, a menos de estar bajo buen control y con terapia médica estable durante al menos los 3 meses anteriores
    7. Manifestación malinga viable del sistema nervioso central (CNS) associada con síntomas clínicos
    8. Haber recibido previamente tratamiento con sorafenib previo para la HCC durante más de 14 días
    9. Haberse sometida a terapia anti-cáncer durante las 4 semanas anteriores al primer tratamiento (6 semanas en caso de mitomicina C o nitrosoureas)
    10. Participation en cualquier otor protocolo de investigación con un fármaco de investigación (IMP) durante los 12 meses anteriores al primer tratamiento
    11. Cualquier otro trastorno médico o anormalidad de laboratorio o infección activa que, a juicio del Investigador Principal (PI) pueda aumentar el riesgo de la participación en el estudio o pueda interferir con la interpretación de los resultados del estudio y/o pueda hacer que sea inadecuado por cualquier otra razón que el paciente participe en este estudio
    12. Uso de interferón/interferón pegilado (PEG-IFN) o ribavirin que no pueda suspenderse durante los 14 días anteriores a cualquier dosis de JX 594.
    13. Evento hemorrágico significativo según evaluación del investigador, durante los últimos 12 meses.
    14. Incapacidad de administrarse agentes de contraste IV yodados para el scanning CT por cause de historia documentada de alergia a los agentes de contraste yodados salvo control mediante intervención médica
    15. Paciente embarazada o en periodo de lactancia
    16. Haber sufrido una severa reacción sistémica o efecto colateral como resultado de anterior vacunación contra la viruela
    17. Paciente incapaz o no dispuesto a cumplir las condiciones del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Radiographic response rate (based on mRECIST for HCC and mChoi criteria) as determined by the independent central review (ICR).
    Indice de respuesta radiográfica (basado en criterios RECIST [mRECIST] modificados y Choi [mChoi] modificados)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Radiographic response rate (based on mRECIST for HCC and mChoi criteria): radiographic assessment every 6 weeks during study treatment and follow-up period, until tumour progression, patient withdrawal or death
    Indice de respuesta radiográfica (basado en criterios RECIST [mRECIST] modificados y Choi [mChoi] modificados): Se efectuará una evaluación clínica cada 6 semanas después de iniciado el tratamiento mientras permanezcan en el estudio
    E.5.2Secondary end point(s)
    ? Safety of JX 594 according to National Cancer Institute ? Common Toxicity Criteria (NCI CTC) version 4.03
    ? Time to progression based on mRECIST for HCC
    ? Overall survival duration
    ? Seguridad del JX 594 administrado por múltiples infusiones intravenosas (IV) a pacientes de HCC avanzado
    ? Tiempo hasta la progresión tumoral (THP) siguiendo los criterios mRECIST para el HCC
    ? Supervivencia global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? Safety: Safety assessment will be conducted at each study visit which means every week during study treatment and every 3 weeks during follow-up period until tumour progression, patient withdrawal or death
    ? Time to progression: CT scan every 6 weeks during study treatment and follow-up period, until tumour progression, patient withdrawal or death
    ? Overall survival duration: Followed for survival at each study visit during study participation and after discontinuation from the study, patients, and/or their specified contacts will continue to be contacted approximately every 4 weeks
    ? Seguridad: La seguridad será monitoreada cada semana durante el estudio y cada 3 semanas durante la period de continuacion del tratamiento
    ? Tiempo hasta la progresión tumoral (THP): Los scans CT se efectuarán cada 6 semanas después de iniciado el tratamiento y durante la period de continuacion del tratamiento
    ? Supervivencia global (SG): la supervivencia de los pacientes será monitoreada cada semana durante la participación en el estudio y después de ser retirados del estudio, los pacientes y/o sus contactos especificados seguirán siendo contactados aproximadamente cada 4 semanas.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Hong Kong
    Korea, Republic of
    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 years1
    E.8.9.1In the Member State concerned months8
    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 months0
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 24
    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)
    Starting at Week 6, patients with a mChoi or mRECIST response or with stable disease and otherwise appear to be clinically benefitting from JX 594 treatment may continue to receive JX 594 every 3 weeks in a treatment extension phase until progressive disease (PD).

    Patients not clinically benefitting or with PD will stop JX 594 treatment. Immediate initiation of sorafenib is strongly recommended.
    Empezando a la semana 6, los pacientes con respuesta mChoi o mRECIST o con enfermedad estable y que además muestren clínicamente estar beneficiándose del tratamiento JX 594 podrán seguir recibiendo el JX 594 cada 3 semanas en un period de continuación del tratamiento hasta enfermedad progresiva (PD).

    A los pacientes que no muestren benficio clínico, o PD se les suspenderá el tratamiento JX 594. Se recomienda enfáticamente la administración inmediata de sorafenib.
    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 Decision2012-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-06-21
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