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    Summary
    EudraCT Number:2008-002072-10
    Sponsor's Protocol Code Number:1199.14
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-04
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-002072-10
    A.3Full title of the trial
    Multicenter, randomised, double-blind, Phase III trial to investigate the
    efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy
    compared to placebo plus standard pemetrexed therapy in patients with
    stage IIIB/IV or recurrent non small cell lung cancer after failure of first
    line chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    BIBF plus Pemetrexed in 2nd line NSCLC patients
    A.4.1Sponsor's protocol code number1199.14
    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 SponsorBoehringer Ingelheim International GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsor
    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 nameVargatef
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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.3.9.2Current sponsor codeBIBF 1120
    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) 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.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 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 nameVargatef
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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.3.9.2Current sponsor codeBIBF 1120
    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) 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 placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    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
    Stage IIIB/IV or recurrent non small cell lung cancer. non squamous histology
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy pemetrexed in patients with Stage IIIB/IV or recurrent NSCLC is more effective compared to placebo in combination with standard therapy pemetrexed. The trial will be limited to non squamous histologies.
    E.2.2Secondary objectives of the trial
    A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120/pemetrexed compared to standard pemetrexed alone. In addition, blood will be collected for pharmacokinetic analysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patient aged 18 years or older
    • Histologically or cytologically confirmed Stage IIIB, IV (according to AJCC) or
    recurrent NSCLC (non squamous histologies)
    • Relapse or failure of one first line chemotherapy (in the case of recurrent disease one additional prior regimen is allowed for adjuvant ,neoadjuvant or neoadjuvant plus adjuvant therapy)
    • At least one target tumor lesion that has not been irradiated within the past three
    months and that can accurately be measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one dimension (longest diameter to be
    recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT
    • Life expectancy of at least three months
    • ECOG score of 0 or 1
    • Patient has given written informed consent which must be consistent with the
    International Conference on Harmonization – Good Clinical Practice (ICH-GCP) and
    local legislation
    E.4Principal exclusion criteria
    - More than one prior chemotherapy regimen for advanced and/or metastatic disease of NSCLC
    - More than one chemotherapy treatment regimen (either neoadjuvant or adjuvant or neoadjvant plus adjuvant) prior to first line chemotherapy of advanced and/or metastatic NSCLC
    - Previous therapy with other VEGFR inhibitors (other than bevacizumab) or
    pemetrexed for treatment of NSCLC
    - Persistence of clinically relevant therapy related toxicities from previous
    chemotherapy and/or radiotherapy
    - Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial
    - Chemo-, hormone-, immunotherapy or therapy with monoclonal antibodies or small
    tyrosine kinase inhibitors within the past four weeks prior to treatment with the trial
    drug, i.e., the minimum time elapsed since the last anticancer therapy and the first
    administration of BIBF 1120 must be four weeks
    - Radiotherapy (except extremities and brain) within the past three months prior to
    baseline imaging
    - Patients taking NSAIDS with short half lives unable or unwilling to interrupt
    NSAIDsS for a five day period (2 days before pemetrexed, day of pemetrexed, 2 days
    after pemetrexed)
    Patients taking NSAIDS with long half lives must interrupt NSAID for 8 days (5 days
    before, day of and 2 days after treatment with pemetrexed)
    - Active brain metastases (e.g. stable for < 4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation)
    - leptomeningeal disease
    - Radiographic evidence of cavitary or necrotic tumors
    - Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of
    major blood vessels
    - History of clinically significant haemoptysis within the past 3 months (more than one tea spoon of fresh blood per day)
    - Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid ≤325mg per day)
    - History of major thrombotic or clinically relevant major bleeding event in the past
    6 months
    - Known inherited predisposition to bleeding or thrombosis
    - 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)
    - Calculated creatinine clearance by Cockcroft Gault <45ml/min
    - Proteinuria CTCAE grade 2 or greater
    - Total bilirubin above the upper limit of normal
    - ALT and/or AST > 2.5 x upper limit of normal in the presence of live metastasis or
    ALT and/or AST >1.5 x upper limit of normal in patients without liver metastasis.
    - Prothrombin time and/or partial thromboplastin time greater than 50% deviation from normal limits
    - Absolute neutrophil count (ANC) < 1500 neutrophils /mm3
    - Platelets < 100,000 platelets/mm
    - Haemoglobin < 9.0 g/dL
    - Significant weight loss (> 10 %) within the past 6 weeks prior to treatment in the
    present trial
    Major injuries and/or surgery within the past ten days prior to randomisation with
    incomplete wound healing
    - Current peripheral neuropathy ≥CTCAE grade 2 except due to trauma
    - Preexisting ascites and/or clinically significant pleural effusion
    - Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial,
    antifungal) therapy
    - Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
    - Active or chronic hepatitis C and/or B infection
    - Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least twelve months after end of active therapy
    - Pregnancy or breast feeding
    - Active alcohol or drug abuse
    - Other malignancy within the past three years other than basal cell skin cancer, or
    carcinoma in situ of the cervix
    - Any contraindications for therapy with pemetrexed
    - History of severe hypersensitivity reactions to pemetrexed or other drugs formulated with mannitol
    - Hypersensitivity to BIBF 1120 and/or the excipients of the trial drugs
    - Hypersensitivity to contrast media
    E.5 End points
    E.5.1Primary end point(s)
    progression free survival (imaging assessed by an independent central review
    according to the modified RECIST criteria)
    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 Yes
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    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
    The clinical trial will be considered completed as soon as the last patient has died or was lost to follow-up. In case patients would still be on treatment when the report of the trial is being performed, these patients will either be included in a follow-up trial or alterantively kept on treatment in this trial. Those patients will then be reported in an addendum to the report.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 71
    F.4.2.2In the whole clinical trial 1300
    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 Decision2008-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
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