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    Summary
    EudraCT Number:2012-001067-79
    Sponsor's Protocol Code Number:ColoAd1-1001
    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:2012-06-12
    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 number2012-001067-79
    A.3Full title of the trial
    A Phase I / II Dose Escalation and Randomised Controlled Trial of ColoAd1 Administered by Sub-acute Fractionated Intravenous Injection to Patients with Metastatic Colorectal Cancer
    Estudio clínico sobre la administración de ColoAd1 en inyección intravenosa subaguda fraccionada: aumento de la dosis en tumores epiteliales sólidos metastásicos y en un ensayo controlado sobre el cáncer colorrectal metastásico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II clinical trial of ColoAd1 by sub-acute fractionated IV dosing in cancer patients
    Estudio de fase I/II de ColoAd1 mediante la administración por vía IV subaguda fraccionada en pacientes con cáncer
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberColoAd1-1001
    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 SponsorPsioxus Therapeutics Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportPsioxus Therapeutics Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINC Research
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address270 Wharfedale Road
    B.5.3.2Town/ cityWinnersh/Berkshire
    B.5.3.3Post codeRG41 5TP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)118 9335347
    B.5.5Fax number+44(0)7775 621845
    B.5.6E-mailASlade@INCResearch.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 ColoAd1
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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.3.9.2Current sponsor codeColoAd1
    D.3.9.3Other descriptive namea live replicating group B chimeric oncolytic adenovirus
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000000000000
    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) 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
    metastatic colorectal cancer
    cáncer colorrectal metastásico
    E.1.1.1Medical condition in easily understood language
    cancer
    cancer
    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 10052362
    E.1.2Term Metastatic colorectal 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
    Phase I:
    - To evaluate the safety and tolerability of ColoAd1, when administered by sub-acute fractionated IV injection to patients with advanced or metastatic epithelial solid tumours not responding to standard therapy or for whom no standard treatment exists
    - To determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of ColoAd1 when administered by sub-acute fractionated intravenous (IV) injection to patients with advanced or metastatic epithelial solid tumours not responding to standard therapy or for whom no standard treatment exists, and to recommend a dose for phase II studies.


    Phase II:
    - To evaluate the progression free survival (PFS) in patients with metastatic colorectal cancer, who receive ColoAd1 administered by sub-acute fractionated IV injection as an intensification of first line chemotherapy compared with first line chemotherapy alone.
    Fase I:
    - Evaluar la seguridad y tolerabilidad de ColoAd1, administrado mediante inyección IV subaguda fraccionada a pacientes con tumores epiteliales sólidos avanzados o metastásicos que no responden al tratamiento estándar o para los que no existe ninguno.
    - Determinar la dosis máxima tolerada (DMT) y/o la dosis máxima posible (DMP) de ColoAd1 administrado mediante inyección intravenosa (IV) subaguda fraccionada a pacientes con tumores epiteliales sólidos avanzados o metastásicos que no responden al tratamiento estándar o para los que no existe ninguno, así como recomendar una dosis para los estudios en fase II.
    Fase II:
    - Evaluar la supervivencia libre de progresión (SLP) en pacientes con cáncer colorrectal metastásico, que reciben ColoAd1 administrado mediante inyección IV subaguda fraccionada como intensificador de la quimioterapia de primera línea en comparación con la quimioterapia de primera línea únicamente.
    E.2.2Secondary objectives of the trial
    Phase I
    - To examine the anti-tumour activity of ColoAd1 administered by sub-acute fractionated IV injection in patients with advanced or metastatic solid tumours of epithelial origin not responding to standard therapy or for whom no standard therapy exists, as measured by response rate, duration of response , clinical benefit rate, progression free survival and overall survival.
    - To assess the kinetics and clearance of ColoAd 1 from the circulation;
    - To assess the potential for ColoAd1 shedding (phase I Dose Escalation only);
    - To measure ColoAd1 specific neutralizing antibody levels

    Phase II
    - To evaluate the dose, safety and tolerability of ColoAd1 when administered by sub-acute fractionated IV injection in sequence with chemotherapy for the first line treatment of metastatic colorectal cancer
    - To further examine the anti-tumour activity of ColoAd1
    Fase I
    - Examinar la actividad antitumoral de ColoAd1 administrado mediante inyección IV subaguda fraccionada a pacientes con tumores sólidos avanzados o metastásicos de origen epitelial que no responden al tratamiento estándar o para los que no existe ninguno, según el índice de respuesta, la duración de la respuesta, el índice de beneficio clínico, la supervivencia libre de progresión y la supervivencia general.
    - Evaluar la farmacocinética y la depuración de ColoAd1 de la circulación.
    - Evaluar el potencial de liberación de ColoAd1 (solo aumento de la dosis de la fase I).
    - Medir los niveles de anticuerpos neutralizantes específicos de ColoAd1.
    Fase II
    - Evaluar la dosis, seguridad y tolerabilidad de ColoAd1, administrado mediante inyección IV subaguda fraccionada junto con quimioterapia como tratamiento de primera línea del cáncer colorrectal metastásico.
    - Examinar aún más la actividad antitumoral de ColoAd1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA FOR ALL PATIENTS
    1 Patients must provide written informed consent
    2 Age ? 18 years and the patient must be at least the legal age limit to be able to give consent within the jurisdiction the study is taking place.
    3 ECOG performance status 0 or 1 (See Appendix 1)
    4 Predicted life expectancy of 3 months or more
    5 Ability to comply with study procedures in the Investigator?s opinion
    6 Recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
    7 Adequate renal, hepatic and bone marrow functions
    8 At least 3 weeks since the last dose of any intravenous systemic chemotherapy and at least two weeks since the last oral dose of capecitabine at time of first administration of ColoAd1.

    For Phase 1 Dose-escalation stage only: Solid tumour of epithelial origin not responding to standard therapy or for whom no standard treatment exists
    For Phase 1 Dose Expansion Stage only: 1. Metastatic colorectal carcinoma not responding to standard therapy, 2. ? 3 prior lines of systemic therapy for advanced disease;


    For Phase 2:
    1. Metastatic colorectal cancer;
    2. Have received 3 - 4 months of first line chemotherapy with either FOLFOX, FOLFIRI or CAPOX, with or without bevacizumab;
    3. At least one measurable lesion according to RECIST 1.1 criteria;
    4. Documented partial response or stable disease;
    5. Eligible to receive chemotherapy with FOLFOX or CAPOX +/- bevacizumab after a short chemotherapy interruption (3-4 weeks), time to administer ColoAd1;
    - Los pacientes deben dar su consentimiento informado por escrito;
    - el paciente debe tener ? 18 años y al menos la edad límite legal para poder dar su consentimiento dentro de la jurisdicción en la que se lleve a cabo el estudio;
    - estado de rendimiento ECOG 0 o 1 (véase el apéndice 1);
    - esperanza de vida prevista de 3 meses o más;
    - capacidad para cumplir los procedimientos del estudio según el juicio del investigador;
    - recuperación hasta el grado 1 de los efectos (sin incluir la alopecia) de cualquier tratamiento anterior para su tumor maligno;
    - función renal aceptable:
    o creatinina ? 1,5 mg/dL o depuración de creatinina calculada mediante la fórmula de Cockcroft-Gault ? 60 mL/min, o bien depuración de creatinina medida ? 60 mL/min,
    o sin hematuria ni proteinuria en análisis de orina;
    - función hepática aceptable:
    o bilirrubina sérica < 1,5 mg/dL,
    o AST y ALT ? 3 x LSN;
    - función medular ósea aceptable:
    o RAN ? 1,5 x 109/L,
    o plaquetas ? 100 x 109/L,
    o hemoglobina ? 90 g/L;
    - pruebas de coagulación aceptables: RIN ? 1,5 x LSN;
    - para mujeres en edad reproductora, se debe documentar una prueba de embarazo en suero negativa en un plazo de 14 días antes de la primera administración del tratamiento del estudio;
    - para mujeres que no sean postmenopáusicas (12 meses de amenorrea) ni se hayan sometido a una operación de esterilización (ausencia de ovarios y/o útero): acuerdo de uso de dos métodos anticonceptivos adecuados durante el período del tratamiento y durante al menos 3 meses después de la última dosis del fármaco en estudio;
    - para hombres: acuerdo de uso de un método anticonceptivo de barrera durante el período de tratamiento y durante al menos 6 meses después de la última dosis del fármaco en estudio;
    - 3 semanas como mínimo desde cualquier dosis de quimioterapia sistémica intravenosa y dos semanas como mínimo desde cualquier dosis oral de capecitabina en el momento de la primera administración de ColoAd1.
    Criterios de inclusión específicos de la fase I
    Solo etapa de aumento de la dosis:
    - Tumores sólidos de origen epitelial que no responden al tratamiento estándar o para los que no existe ninguno
    Solo etapa de ampliación de la dosis:
    - Carcinoma colorrectal metastásico que no responde al tratamiento estándar
    - ? 3 líneas de terapia sistémica anteriores para la enfermedad avanzada
    Criterios de inclusión específicos de la fase II
    - Cáncer colorrectal metastásico;
    - haber recibido durante 3-4 meses quimioterapia de primera línea con FOLFOX, FOLFIRI o CAPOX, con o sin bevacizumab;
    - al menos una lesión medible según los criterios RECIST 1.1;
    - respuesta parcial o enfermedad estable documentada;
    - apto para recibir quimioterapia con FOLFOX o CAPOX tras una breve interrupción de la quimioterapia (de 3 a 4 semanas).
    E.4Principal exclusion criteria
    For all patients:
    Pregnant or breast feeding females;
    Known history or evidence of significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks);
    Splenectomy;
    Prior allogeneic or autologous bone marrow or organ transplantation;
    Active infections requiring antibiotics, physician monitoring, or recurrent fevers >38.0 degrees centigrade associated with a clinical diagnosis of active infection ;
    Active viral disease or known positive serology for HIV, hepatitis B or hepatitis C;
    Use of the following anti-viral agents: ribavirin, adefovir, lamivudine or cidofovir within 7 days prior to day 1; or PEG-IFN (within 14 days prior to first administration of ColoAd1);
    Administration of an investigational drug within 28 days prior to first dose of ColoAd1;
    Major surgery within 4 weeks or radiotherapy within 3 weeks prior to first dose of ColoAd1;
    Another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ);
    CNS metastasis that is symptomatic and/or requires treatment;
    Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the drug;
    Known allergy to treatment medication or its excipients ;
    Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

    For Phase 2 patients:
    Progression on first line therapy;
    A complete response on first line therapy;
    Use of first line therapy for longer than 4 months;
    Use of any first line treatment with a chemotherapy regimen other than FOLFOX, FOLFIRI or CAPOX (with or without bevacizumab).
    More than 6 weeks since the last administration of 5 FU, capecitabine, oxaliplatin or irinotecan.

    Household contact: Pregnant or breast feeding females; Children < 1 year old; A household contact with significant immunodeficiency due to underlying illness (e.g.HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
    - Mujeres embarazadas o en período de lactancia;
    - historial conocido o evidencia de inmunodeficiencia importante por una enfermedad subyacente (p. ej., VIH/SIDA) y/o medicación (p. ej., corticosteroides sistémicos u otra medicación inmunosupresora, incluidos ciclosporina, azatioprina, interferones, en las 4 últimas semanas);
    - esplenectomía;
    - trasplante alogénico o autólogo de un órgano o de médula ósea anterior;
    - infecciones activas que requieran antibióticos, supervisión médica o fiebres recurrentes > 38,0 grados centígrados asociadas a un diagnóstico clínico de infección activa;
    - enfermedad vírica activa o serología positiva conocida para VIH, hepatitis B o hepatitis C;
    - uso de los siguientes agentes antivirales: ribavirina, adefovir, lamivudina o cidofovir en los 7 días anteriores al día 1; o bien PEG-IFN (en los 14 días anteriores a la primera administración de ColoAd1);
    - administración de un fármaco en investigación en los 28 días anteriores a la primera dosis de ColoAd1;
    - cirugía mayor en las 4 semanas anteriores a la primera dosis de ColoAd1 o radioterapia en las 3 semanas anteriores;
    - otro tumor maligno primario en los 3 últimos años (excepto cáncer de piel no melanoma o cáncer cervical in situ);
    - metástasis en el SNV que sea sintomática y/o requiera tratamiento;
    - cualquier condición o enfermedad que, según el juicio del investigador o el supervisor médico, ponga en riesgo la seguridad del paciente o afecte a la evaluación de la seguridad del fármaco;
    - alergia conocida a la medicación del tratamiento o sus excipientes;
    - cualquier otra condición médica o psicológica que descarte la participación en el estudio o comprometa la capacidad de dar el consentimiento informado.
    Criterios de exclusión solo para los pacientes de la fase II
    - Continuación del tratamiento de primera línea;
    - respuesta completa al tratamiento de primera línea;
    - uso de tratamiento de primera línea durante más de 4 meses;
    - uso de cualquier tratamiento de primera línea con un régimen de quimioterapia que no sea FOLFOX, FOLFIRI o CAPOX (con o sin bevacizumab);
    - más de 6 semanas desde la última administración de 5-FU, capecitabina, oxaliplatino o irinotecán.

    Exclusiones por contactos familiares para todos los pacientes
    Cualquier paciente con contactos familiares que cumplan cualquiera de los criterios siguientes serán excluidos a menos que se pueda disponer de una vivienda alternativa mientras dure el período de tratamiento con ColoAd1, es decir, 56 días después de la última administración de ColoAd1:
    -Mujeres embarazadas o lactantes
    -Niños menores de 1 año
    -Inmunodeficiencia importante por una enfermedad subyacente (p. ej., VIH/SIDA) y/o medicación (p. ej., corticosteroides sistémicos)
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1: Safety and tolerability
    Determine a maximum tolerated dose (MTD) / maximum feasible dose (MFD) of ColoAd1 when administered by sub-acute fractionated IV injection (phase I Dose Escalation) and a recommended dose for phase II studies

    Phase 2: Rate of Progression-Free Survival (PFS) at 24 weeks, defined as the rate of patients being free from clinical/radiological progression and alive within the week 24 time window from randomisation as determined by an independent review committee.
    Fase I:Seguridad y tolerabilidad
    Determinar una dosis máxima tolerada (DMT)/dosis máxima posible (DMP) de ColoAd1 administrado mediante inyección IV subaguda fraccionada (aumento de la dosis de la fase I) y una dosis recomendada para los estudios en fase II.
    Fase II: Índice de supervivencia libre de progresión (SLP) a las 24 semanas, definida como el índice de pacientes sin progresión clínica/radiológica y vivos en el período de tiempo de 24 semanas desde la aleatorización según lo determinado por un comité de revisión independiente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1 - 61 days

    Phase 2 - 24 weeks
    Fase I: 61 días
    Fase II: 24 semanas
    E.5.2Secondary end point(s)
    Phase I
    - Response rate defined by RECIST v1.1
    - Duration of response defined by RECIST v1.1
    - Clinical benefit (CB) rate i.e. complete response (CR) + partial response (PR) + stable disease (SD) ?12 weeks defined by RECIST v1.1
    - Progression-Free Survival, defined as the number of days from date of randomization to date of documented clinical/radiological progression or date of death, whichever is earlier.
    - Overall survival defined as the time from first dose of ColoAd1 to death due to any cause.
    - Kinetics and clearance of ColoAd 1 from the circulation (phase I Dose Escalation only)
    - ColoAd1 shedding (phase I Dose Escalation only);

    Phase II
    - Safety and tolerability
    - Progression-Free Survival, defined as the number of days from date of randomization to date of documented clinical/radiological progression or date of death, whichever is earlier.
    - Response rate according to RECIST 1.1 criteria
    - Response rate according to Choi?s criteria
    - Duration of response defined by RECIST v1.1
    - Clinical benefit (CB) rate i.e. complete response (CR) + partial response (PR) + stable disease (SD) ?12 weeks defined by RECIST v1.1
    - Overall survival defined as the time from first dose of ColoAd1 to death due to any cause.
    Fase I
    - Índice de respuesta definida por RECIST v1.1
    - Duración de la respuesta definida por RECIST v1.1
    - Índice de beneficio clínico (BC), es decir, respuesta completa (RC) + respuesta parcial (RP) + enfermedad estable (EE) ? 12 semanas, definida por RECIST v1.1
    - Supervivencia libre de progresión, definida como el número de días desde la fecha de la aleatorización hasta la fecha de la progresión clínica/radiológica documentada o la fecha de la muerte, lo que se produzca antes.
    - Supervivencia general definida como el tiempo desde la primera dosis de ColoAd1 hasta la muerte por cualquier causa.
    - Farmacocinética y depuración de ColoAd1 de la circulación (solo aumento de la dosis de la fase I)
    - Liberación de ColoAd1 (solo aumento de la dosis de la fase I)

    Fase II
    - Seguridad y tolerabilidad
    - Supervivencia libre de progresión, definida como el número de días desde la fecha de la aleatorización hasta la fecha de la progresión clínica/radiológica documentada o la fecha de la muerte, lo que se produzca antes.
    - Índice de respuesta según los criterios RECIST 1.1
    - Índice de respuesta según los criterios de Choi
    - Duración de la respuesta definida por RECIST v1.1
    - Índice de beneficio clínico (BC), es decir, respuesta completa (RC) + respuesta parcial (RP) + enfermedad estable (EE) ? 12 semanas, definida por RECIST v1.1
    - Supervivencia general definida como el tiempo desde la primera dosis de ColoAd1 hasta la muerte por cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    61 days/ 120 days
    61 días / 120 días
    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 Yes
    E.6.13.1Other scope of the trial description
    Dose escalation/dose finding
    Escalada dosis/busqueda de dosis
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    escalada de dosis y aleatorización abierta
    dose escalation and open label randomised
    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
    sin comparador; MI seguido de quimioterapia comparado a quimioterapia solo
    no comparator used; compared IMP followed by chemotherapy to chemotherapy alone
    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.8.4.1Number 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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end-of-trial (completion) date is when all patients will complete all study visits or have otherwise discontinued from the study.
    La fecha de fin del estudio (finalizacion) es cuando todos los pacientes completen toidas las visitas o bien hubiesen discontinuado el estudio.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 99
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 108
    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)
    Patients will be initiated on second line chemotherapy (as determined by the treating physician) when indicated by objectively measured progressive disease according to RECIST 1.1 criteria
    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 Decision2012-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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