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    Summary
    EudraCT Number:2013-004324-11
    Sponsor's Protocol Code Number:NVALT-15
    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:2015-01-16
    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 number2013-004324-11
    A.3Full title of the trial
    Phase II study with oral fibroblast growth factor-1 inhibitor BIBF1120 as second line treatment in lung carcinoma patients harboring fibroblast growth factor receptor-1 gene amplification (NVALT-15 study)
    ?Estudio Fase II con BIBF1120, un inhibidor oral del factor 1 de crecimiento de fibroblastos, como tratamiento de segunda línea en pacientes con cáncer de pulmón no microcítico y amplificación del gen del receptor 1 del factor de crecimiento de fibroblasto?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with BIBF1120 in lung canger patients with an abnormal fibroblast growth factor-1 receptor (NVALT-15 study)
    Estudio con BIBF1120 en pacientes con cáncer de pulmón y amplificación del gen de receptor 1 de crecimiento de fibroblastos
    A.3.2Name or abbreviated title of the trial where available
    NVALT-15
    A.4.1Sponsor's protocol code numberNVALT-15
    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 SponsorStichting NVALT studies
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportStichting NVALT studies
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStichting NVALT studies
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressLuijbenstraat 15
    B.5.3.2Town/ citydEN bOSCH
    B.5.3.3Post code5211 BR
    B.5.3.4CountryNetherlands
    B.5.4Telephone numbernananana
    B.5.5Fax numbernananana
    B.5.6E-mailh.j.m.groen@umcg.nl
    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 Yes
    D.2.1.1.1Trade name Vargatef
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVargatef
    D.3.2Product code BIBF1120
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    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 INNnintedanib
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeBIBF1120
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    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
    Cáncer de pulmón de célula no pequeña
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    cáncer de pulmón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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
    Effect of BIBF1120 as a second line treatment on progression-free survival of patients with FGFR1 amplification.
    el objetivo principal es la supervivencia libre de progresión a seis meses (SLP a seis meses) de los pacientes con cáncer pulmonar con amplificación del gen FGFR1 en sus células tumorales
    E.2.2Secondary objectives of the trial
    Tumor response rate, duration of tumor response, overall survival, safety.
    tasa de respuesta tumoral, la duración de la respuesta tumoral, la supervivencia global y la seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Stage IIIB or IV after failure of first line treatment or recurrent NSCLC haboring a positive FISH for FGFR1 amplification (> 2 copies). Six unstained slides will be provided to the UMC Groningen to perform the test.
    2. Age above 18 years.
    3. Measurable tumor lesions (RECIST 1.1)
    4. Life expectancy of at least 3 months.
    5. Eastern Cooperative Oncology Group (ECOG) score of 0 - 1.
    6. Patients who have sufficient baseline organ function and who meet the following criteria at the enrolment:
    o Absolute neutrophil count (ANC) ? 1500/mm3;
    o Platelet count ? 100 000/mm3;
    o Total bilirubin under the upper limit of normal (=upper limit of the local laboratory facility);
    o AST/SGOT and/or ALT/GPT <=1.5 x upper limit of normal (if related to liver metastases <=2.5 x upper limit of normal);
    o Proteinuria Common Terminology Criteria for Adverse Events (CTCAE version 3.0) grade 1 or less;
    o Calculated creatinine clearance by Cockcroft Gault ? 45 mL/min;
    o Prothrombin time-international normalized ratio (PT-INR) and/or partial thromboplastin time (PTT) within normal limits;
    o Oxygen saturation by pulse-oximeter SpO2 ? 92%;
    7. Patient has given written informed consent which must be consistent with ICH-GCP and local legislation.
    1. Estadio IIIB o IV tras fracaso del tratamiento de primera línea o NSCLC recurrente con amplificación de FGFR1 (> 2 copias) mediante FISH. Para la realización de esta prueba, se proporcionaron a UMC Groningen seis extensiones no teñidas.
    2. Edad superior a 18 años.
    3. Lesión tumoral medible (RECIST 1.1)
    4. Esperanza de vida de al menos 3 meses.
    5. Puntuación ECOG (Eastern Cooperative Oncology Group) de 0 - 1.
    6. Pacientes con función orgánica basal suficiente y que cumplan los siguientes criterios en el reclutamiento:
    o Recuento absoluto de neutrófilos (RAN) ? 1.500/mm3;
    o Recuento de plaquetas ? 100.000/mm3;
    o Bilirrubina total por debajo del límite superior de normalidad (= límite superior del laboratorio local);
    o AST/SGOT y/o ALT/GPT ?1,5 x límite superior de normalidad (si está relacionado a metástasis hepáticas ?2,5 x límite superior de normalidad);
    o Proteinuria de grado 1 o inferior de los criterios de terminología común para acontecimientos adversos (CTCAE versión 3.0);
    o Aclaramiento de creatinina calculado según Cockcroft Gault ? 45 ml/min;
    o Tiempo de protrombina-índice internacional normalizado (TP-INR) y/o tiempo de tromboplastina parcial (TTP) dentro de los límites normales;
    o Saturación de oxígeno por oximetría de pulso SpO2 ? 92%;
    7. El paciente ha dado el consentimiento informado por escrito (debe estar de acuerdo con la ICH-GCP y la legislación local).
    E.4Principal exclusion criteria
    1. Patients who have received treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with this trial or who have not recovered from side effects of such therapy (except for alopecia).
    2. Patients who have received chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug or who have not recovered from side effects of such therapy (except for alopecia).
    3. Patients who have received radiotherapy on the target lesions within 4 weeks prior to treatment with the trial drug (in case of palliative radiotherapy such as for extremities, within 2 weeks prior to treatment with the trial drug).
    4. Previous therapy with other vascular endothelial growth factor receptor (VEGFR) inhibitors or vascular endothelial growth factor (VEGF) ligand inhibitors for treatment of NSCLC.
    5. Previous therapy with BIBF1120.
    6. Patients who have symptomatic brain metastases or leptomeningeal disease.
    7. Radiographic evidence of cavitation or necrotic tumors.
    8. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels.
    9. History of clinically significant haemoptysis within the past 3 months.
    10. Known inherited predisposition to bleeding or thrombosis.
    11. Current peripheral neuropathy CTCAE version 3.0 grade 2 or greater except due to trauma.
    12. Pre-existing ascites and/or clinically significant pleural effusion.
    13. Major injuries and/or surgery within the past 4 weeks prior to treatment.
    14. Clinically serious infections.
    15. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
    16. Patients who have active or chronic hepatitis C and/or B infection and diagnosis of human immunodeficiency virus (HIV) infection.
    17. Other malignancy other than basal cell skin cancer, carcinoma in situ or intra-mucosal cancer that were judged to be cured by adequate treatment and disease-free interval is more than 5 years.
    18. History of serious drug hypersensitivity.
    19. Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric-, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation.
    20. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except acetylsalicylic acid up to 100 mg daily).
    21. Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
    22. Pregnancy or breast feeding.
    23. Patients unable to comply with the protocol.
    1. Pacientes que hayan recibido tratamiento con otros fármacos en investigación o tratamiento en otro ensayo clínico en las 4 semanas anteriores al inicio del tratamiento o concomitantemente con este ensayo o que no se han recuperado de los efectos secundarios de esta terapia (excepto alopecia).
    2. Pacientes que han recibido quimioterapia, hormonoterapia, inmunoterapia o terapia con anticuerpos monoclonales o inhibidores de molécula pequeña de tirosina cinasa en las 4 semanas anteriores al tratamiento con el fármaco de ensayo o que no se han recuperado de los efectos secundarios de esta terapia (excepto alopecia).
    3. Pacientes que han recibido radioterapia en las lesiones diana en las 4 semanas anteriores al tratamiento con el fármaco de ensayo (en caso de radioterapia paliativa como la que se aplica a las extremidades, en las 2 semanas anteriores al tratamiento con el fármaco de ensayo).
    4. Terapia previa con otros inhibidores del receptor del factor de crecimiento del endotelio vascular (VEGFR) o con inhibidores del ligando del factor de crecimiento del endotelio vascular (VEGF) para tratamiento de NSCLC.
    5. Terapia previa con BIBF1120.
    6. Pacientes con metástasis cerebrales sintomáticas o enfermedad leptomeníngea.
    7. Evidencia radiográfica de cavitación o tumores necróticos.
    8. Tumores de localización central con evidencia radiográfica (TC o RM) de invasión local de vasos sanguíneos mayores.
    9. Antecedentes clínicamente significativos de hemoptisis en los 3 meses anteriores.
    10. Predisposición hereditaria conocida a hemorragia o trombosis.
    11. Neuropatía periférica actual de grado 2 o superior CTCAE versión 3.0 excepto la debida a traumatismo.
    12. Ascitis y/o derrame pleural clínicamente significativo preexistente.
    13. Lesiones importantes y/o cirugía en las 4 semanas anteriores al tratamiento.
    14. Infecciones clínicamente graves.
    15. Trastornos o anomalías gastrointestinales que podrían interferir con la absorción del fármaco del estudio.
    16. Pacientes con hepatitis C activa o crónica y/o infección B y diagnóstico de infección por el virus de la inmunodeficiencia humana (VIH).
    17. Otros tumores malignos distintos de cáncer cutáneo de células basales, carcinoma in situ o cáncer intramucoso que se consideró curado con tratamiento adecuado e intervalo libre de enfermedad superior a 5 años.
    18. Antecedentes de hipersensibilidad grave a fármacos.
    19. Enfermedad grave o enfermedad concomitante no oncológica, como enfermedad neurológica, psiquiátrica, infecciones o úlcera activa (gastrointestinal, cutánea) o anomalía de laboratorio que pueda aumentar el riesgo asociado a la participación en el estudio.
    20. Anticoagulación terapéutica (excepto heparina a dosis bajas y/o flush de heparina según necesidad para el mantenimiento de un catéter intravenoso permanente) o terapia antiplaquetaria (excepto ácido acetilsalicílico hasta 100 mg/día).
    21. Pacientes sexualmente activos que no desean utilizar un método anticonceptivo médicamente aceptable.
    22. Embarazo o lactancia.
    23. Pacientes incapaces de cumplir con el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival
    Supervivencia libre de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously
    contínuo
    E.5.2Secondary end point(s)
    Response, overall survival, safety
    Respuesta, supervivencia global y seguridad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuously
    continuo
    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 Yes
    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.8.3 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Last patient last visit
    última visita del último paciente
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    Standard treatment
    Tratamiento estándar
    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 Decision2015-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-01-15
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