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    Summary
    EudraCT Number:2014-003891-22
    Sponsor's Protocol Code Number:BIO_LUME_1
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-08-20
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-003891-22
    A.3Full title of the trial
    Nintedanib (BIBF 1120) plus docetaxel in NSCLC patients progressing after first-line CTX: angiogenic biomarker identification, phase II trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nintedanib (BIBF 1120) plus docetaxel in non-small cell lung cancer (NSCLC) patients progressing after first-line chemotherapy (CTX): angiogenic biomarker identification, phase II trial
    A.4.1Sponsor's protocol code numberBIO_LUME_1
    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 SponsorMedical University Innsbruck
    B.1.3.4CountryAustria
    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 supportMedical University Innsbruck
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Innsbruck
    B.5.2Functional name of contact pointDepartment of Internal Medicine V
    B.5.3 Address:
    B.5.3.1Street AddressAnichstraße 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.6E-mailandreas.pircher@i-med.ac.at
    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 nameNintedanib (BIBF 1120)
    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.3.9.3Other descriptive nameBIBF 1120
    D.3.9.4EV Substance CodeSUB21204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 2
    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 nameNintedanib (BIBF 1120)
    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.3.9.3Other descriptive nameBIBF 1120
    D.3.9.4EV Substance CodeSUB21204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.IMP: 3
    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 nameNintedanib (BIBF 1120)
    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.3.9.3Other descriptive nameBIBF 1120
    D.3.9.4EV Substance CodeSUB21204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    The project aims for screening for potential biomarkers and biomarker combinations relevant for second line setting in NSCLC during combinational therapy with docetaxel and nintedanib. The predicitve value of such profiles should then be evaluated in larger cohorts.
    E.1.1.1Medical condition in easily understood language
    Screening for potential biomarkers and biomarker combinations relevant for second line setting in non-small cell lung cancer (NSCLC) during combinational therapy with docetaxel and nintedanib.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study is to explore novel biomarkers and to evaluate biomarker combinations measured in different biosamples (plasma, whole blood, DNA, tumor tissue) when combined with clinical parameters.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients of at least 18 years of age
    2. Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy. First line chemotherapy for locally advanced, or metastatic (stage IIIB or IV NSCLC according to American Joint Committee on Cancers, Version 7) or recurrent disease may include continuation or switch maintenance therapy administered in the absence of disease progression. One prior adjuvant and/or neoadjuvant chemotherapy is permissible.
    3. Time between start of first-line chemotherapy and relapse (defined by RECIST criteria, date of CT) ≥ 9 months (275 days) or ≤ 6 months (183 days). (Commentary: Patients relapsing between 184 – 274 days after start of first-line chemotherapy are not evaluable).
    4. At least one target tumor lesion that has not been irradiated within the past three months and that can be accurately measured by computerized tomography (CT) with a longest diameter of ≥ 10 mm or ≥15 mm in the short-axis diameter for a lymph node. If there is only one target lesion, and it is a non-lymph node, it should have a longest diameter of ≥15 mm
    5. ECOG performance status score (0 or 1)
    6. Signed and dated written informed consent in accordance with ICH-GCP guidelines and the local legislation
    7. Before study entry a re-biopsy of the tumor is mandatory for inclusion. A CT-guided biopsy or bronchoscopy with 5-6 core biopsies is required to enable the acquisition of adequate tissue. Routine IHC analysis for tumor diagnostics should be performed. EGFR mutational status and EML4/ALK status have to be assessed on the biopsies.
    8. Patients will be asked if they voluntarily agree to obtain tumor tissue post mortem.

    E.4Principal exclusion criteria
    1) More than one prior line of chemotherapy (i.e. 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease. Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation. Patients known to be positive for ALK translocation. Non-permissible treatments: Previous therapy with other VEGF or VEGFR inhibitors or docetaxel for the treatment of NSCLC at any time.
    2) Prior monotherapy with an EGFR inhibitor except as maintenance therapy
    3) Non-permissible treatments within 4 weeks prior to start of study therapy:
    a) Other investigational drugs
    b) Chemo-, hormone-, radiotherapy (except for radiotherapy to extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors
    c) Radiotherapy (except extremities and brain) within the past three months prior to baseline imaging
    d) Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy (AE from previous treatment ≥ Grade 2)
    e) In case of prior maintenance treatment the last administration should have been performed at least 3 weeks or longer prior to start of study therapy
    f) Patients receiving erythropoiesis stimulating agents (ESA)
    4) Laboratory values outside the following ranges:
    a) Serum creatinine > 1.5 times the upper limit of normal (ULN)
    b) Proteinuria CTCAE grade 2 or greater
    c) Total bilirubin above the upper limit of normal
    d) ALT or AST > 1.5 x upper limit of normal
    e) Prothrombin time and/or partial thromboplastin time greater than 50 % deviation from normal limits
    f) International normalised ratio ( INR) > 3
    g) Absolute neutrophil count (ANC) < 1500/mm3
    h) Platelets < 100000/ mm3
    i) Haemoglobin < 9.0 g/dL
    5) Any of the following conditions:
    a) Pre-existing ascites and/or clinically significant pleural effusion
    b) Significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the present trial
    c) Current peripheral neuropathy, CTCAE grade 2, except due to trauma
    d) Major injuries and/or surgery within the past ten days prior to randomisation with incomplete wound healing
    e) Decompensated diabetes mellitus or other contraindication to high dose corticosteroid therapy
    f) Active or chronic hepatitis C and/or B infection
    g) Serious illness or concomitant non-oncological disease such as neurologic-, psychiatric active alcohol or drug abuse, infectious disease or active ulcers (gastro-intestinal malabsorption or other conditions, skin), history of hollow-organ perforations or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study
    h) Other malignancy within the past three years other than basal cell skin cancer, or carcinoma in situ of the cervix
    i) Leptomeningeal disease or active brain metastases. If brain metastases have been treated, they must be stable for >4 weeks. Dexamethasone therapy will be allowed if administered as stable dose for at least two weeks before randomisation
    j) Radiographic evidence of cavitary tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
    k) History of clinically significant haemoptysis within the past 3 months (more than one teaspoon of fresh blood per day)
    l) Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device is allowed) or anti-platelet therapy (except for chronic low-dose therapy with acetylsalicylic acid ≤ 325mg per day)
    m) History of major thrombotic event or known inherited predisposition to thrombosis, or clinically relevant major bleeding event in the past 6 months
    n) Significant cardiovascular diseases (i.e. hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion
    6) Patients of childbearing potential who are sexually active and unwilling to use a highly effective method of contraception during the trial and for at least 3 months after the end of the treatment with nintedanib and for at least 6 months after the end of the therapy with docetaxel.
    7) Pregnancy or breast feeding
    8) Any contraindications for therapy with docetaxel or history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80 (Tween 80). Hypersensitivity to nintedanib and/or the excipients of the trial drugs. Hypersensitivity to contrast media
    9) Patients unable to comply with the study protocol and follow-up schedule, for any reason
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study will be an exploratory primary endpoint which combines progression free survival (PFS) in conjunction with the planned biomarker analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor progression has to be performed at six weeks intervals starting six weeks (+/- 2 days) after very first administration of doxetacel.
    E.5.2Secondary end point(s)
    o Eploratory primary endpoint Progression free survival (PFS) in conjunction with biomarker analysis.
    o Progression free survival (PFS): This is defined as the interval of time between start of the actual therapy and the first documentation of progression or death.
    o Time to progression during AAT (aTTP): This modified endpoint is defined as the interval of time between the time of marker analysis and the first documentation of progression or death.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression free survival (PFS) is evaluated in intervals of six weeks together with biomarker analysis.
    Final analyses will be performed at the end of the study.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Prognosis
    The project aims for screening for potential biomarkers and biomarker combinations relevant for second line setting in NSCLC during combinational therapy with docetaxel and nintedanib. The predicitve value of such profiles should then be evaluated in larger cohorts. In the future such profiles could possibly help clinicians to identify those patients who might probably benefit and to use these agents more effectively.
    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 concerned7
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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.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)
    None
    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 Decision2015-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-18
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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