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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-012709-20
    Sponsor's Protocol Code Number:LF-0207
    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:2009-09-24
    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 number2009-012709-20
    A.3Full title of the trial
    A Phase 3, randomized, double-blind, placebo-controlled study of oral talactoferrin in addition to best supportive care in patients with non-small cell lung cancer who have failed two or more prior treatment regimens.

    FORTIS-M: estudio en fase 3 aleatorizado, doble ciego y controlado con placebo de talactoferrina oral añadida al mejor tratamiento de apoyo en pacientes con cáncer de pulmón no microcítico que no han respondido a dos o más tratamientos previos
    A.3.2Name or abbreviated title of the trial where available
    FORTIS-M
    A.4.1Sponsor's protocol code numberLF-0207
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAgennix Incorporated
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameTalactoferrina alfa
    D.3.2Product code TLF
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTalactoferrina alfa
    D.3.9.1CAS number 308240-58-6
    D.3.9.2Current sponsor codeTLF
    D.3.9.3Other descriptive nameTalactoferrina alfa
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-small cell lung cancer in patients who have failed two or more prior treatment regimens.

    Pacientes con cáncer de pulmón no microcítico que no han respondido a dos o más tratamientos previos
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la supervivencia global
    E.2.2Secondary objectives of the trial
    • Determinar la tasa de supervivencia a seis meses y un año.
    • Determinar la supervivencia sin progresión.
    • Determinar la tasa de respuesta objetiva del tumor.
    • Determinar la tasa de estabilización de la enfermedad.
    • Evaluar la seguridad y tolerabilidad de talactoferrina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Mayor de 18 años.
    2. CPNM en estadio IIIB o IV confirmado histológica o citológicamente.
    3. Fracaso de al menos 2 tratamientos antitumorales sistémicos previos para el CPNM avanzado o metastásico. Deben cumplirse los siguientes criterios:
    • El fracaso se define como progresión de la enfermedad o toxicidad inaceptable.
    • El paciente debe haber recibido un tratamiento que contenga platino para el CPNM avanzado o metastásico.
    • Debe haberse producido el fracaso del tratamiento antitumoral sistémico más reciente.
    4. Al menos una lesión objetivo no irradiada y cuantificable según los criterios RECIST.
    5. Hemoglobina > ó = 9 g/dl.
    6. Recuento absoluto de neutrófilos > ó = 2000/mm3.
    7. Linfocitos > ó = 800/mm3.
    8. Recuento de plaquetas > ó = 100.000/mm3.
    9. Bilirrubina total < ó = 1,5 mg/dl.
    10. Creatinina < ó = 2,0 mg/dl.
    11. AST (SGOT) y ALT (SGPT) < ó = 2,5 veces el límite superior normal (LSN).
    12. Lactato deshidrogenasa < ó = 1,5 veces el LSN.
    13. Grado de actividad de Karnofsky > 50 (ECOG 0, 1 ó 2).
    14. Esperanza de vida >12 semanas.
    15. Capaz de entender y firmar un consentimiento informado
    E.4Principal exclusion criteria
    1. Presencia de metástasis cerebrales, a menos que el paciente recibiera irradiación cerebral, incluido radiocirugía estereotáctica adecuada, al menos 4 semanas antes de la asignación aleatoria, y esté estable, asintomático y sin esteroides durante al menos 3 semanas antes de la asignación aleatoria.
    2. Antecedentes de reacciones alérgicas a compuestos de composición química y biológica similar a la talactoferrina.
    3. Cualquier enfermedad gastrointestinal u otra afección que tenga como resultado la incapacidad para tomar medicación oral.
    4. Antecedentes de otras neoplasias malignas, excepto: i) carcinoma cutáneo basocelular o espinocelular adecuadamente tratado; ii) a) carcinoma in situ de cuello uterino, b) cáncer de próstata o c) cáncer de vejiga superficial curados con tratamiento o iii) otros tumores sólidos curados sin indicios de enfermedad durante > ó = 5 años.
    5. Cardiopatía coronaria no controlada o insuficiencia coronaria congestiva sintomática no controlada.
    6. Infección activa grave.
    7. Enfermedad psiquiátrica / situaciones sociales que podrían limitar el cumplimiento del estudio.
    8. Otras enfermedades crónicas graves no controladas o afecciones que en opinión del investigador podrían afectar al cumplimiento o seguimiento del protocolo.
    9. Radioterapia concurrente en cualquier sitio, radioterapia en las 4 semanas previas a la asignación aleatoria o radioterapia previa en los sitios de lesiones objetivo (sitios de los que se debe hacer un seguimiento para la determinación de la respuesta).
    10. Positivo para el VIH o en tratamiento antirretroviral activo.
    11. Positivo para el antígeno de superficie del virus de la hepatitis B o positivo para la hepatitis C.
    12. Receptor de cualquier tratamiento anticanceroso sistémico o de medicación en investigación en las 4 semanas previas a la asignación aleatoria.
    13. Pacientes embarazadas o en periodo de lactancia, o mujeres fértiles con prueba de embarazo positiva (gonadotropina coriónica humana &#946; [&#946;-hCG] en la selección o al inicio) o mujeres fértiles que no estén dispuestas a utilizar métodos anticonceptivos durante el tratamiento y 30 días después de finalizarlo.
    14. Pacientes varones sexualmente activos que no estén dispuestos a utilizar métodos anticonceptivos durante la participación en el estudio y hasta 30 días después de completar el tratamiento.
    15. Incapacidad legal o capacidad legal limitada, a menos que un tutor legal conceda su autorización.
    16. Tratamiento con corticoesteroides orales en las 4 semanas previas a la asignación aleatoria o se espera que esté en tratamiento durante el estudio, excepto terapia de sustitución para la insuficiencia suprarrenal
    E.5 End points
    E.5.1Primary end point(s)
    Principal:
    • Supervivencia global (SG)
    Secundarios:
    • Tasa de supervivencia a seis meses y un año.
    • Supervivencia sin progresión (SSP).
    • Tasa de respuesta objetiva (TRO): respuesta parcial + respuesta completa (RP+RC) confirmada radiológicamente, según los criterios RECIST.
    • Tasa de estabilización objetiva de la enfermedad (RP+RC+enfermedad estable [EE]).

    Seguridad
    • Número de acontecimientos adversos al mes mientras se están recibiendo los fármacos del estudio.
    • Número de acontecimientos adversos de grado 3 ó 4 al mes mientras se están recibiendo los fármacos del estudio.
    • Incidencia de acontecimientos adversos de grado 3 ó 4.
    • Incidencia de acontecimientos adversos de grado 3 ó 4 pulmonares o de las vías respiratorias superiores.
    • Incidencia de acontecimientos adversos de grado 3 ó 4 gastrointestinales
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Todos los pacientes recibirán el mejor tto de apoyo y se asignarán aleatoriamente en la proporción 2:1 a talactoferrina o placebo. Se hará seguimiento de la supervivencia de al menos 12 meses desde la fecha de aleatorización o hasta la fecha de cierre para el análisis principal de supervivencia global. Este último se calculará a los 576 acontecimientos. Los parámetros estadísticos calculados con 576 acontecimientos deberán proporcionar datos suficientes para mostrar la actividad del PEI
    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 months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 720
    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)
    El paciente debe recibir el tratamiento normal esperado después de la 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 Decision2009-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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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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