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    Summary
    EudraCT Number:2008-002072-10
    Sponsor's Protocol Code Number:1199.14
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-15
    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 ConcernedPoland - Office for Medicinal Products
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BIBF 1120 plus pemetrexed compared to placebo plus pemetrexed in 2nd line nonsquamous NSCLC
    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.5.2US NCT (ClinicalTrials.gov registry) numberNCT00806819
    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 SponsorBoehringer Ingelheim International GmbH
    B.1.3.4CountryGermany
    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 supportBoehringer Ingelheim International GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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.3.1Product nameBIBF 1120 100 mg capsules
    D.3.2Product code 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.3.9.2Current 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) 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 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 nameBIBF 1120 150 mg capsules
    D.3.2Product code 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.3.9.2Current 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) 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
    Stage IIIB/IV or recurrent non small cell lung cancer. non squamous histology
    E.1.1.1Medical condition in easily understood language
    Advanced cancer of the lung of a certain type of cell-histology
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 16.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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
    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.

    Changes related to Protocol Amendment 3, dated 08. August 2011:
    No further recruitment into this trial is permitted. All patients who were
    on active treatment as of June 18th, 2011 were unblinded and placebo
    was discontinued for all patients. All patients who decided to continue on
    their active active treatment based on an observed treatment benefit
    and after discussion with their treating physician receive either
    monotherapy with pemetrexed (standard of care treatment) or
    monotherapy with BIBF 1120 (investigational medicinal product) or
    combination therapy with pemetrexed + BIBF 1120 in case of an
    observed treatment benefit.
    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 with monoclonal antibodies, treatment with tyrosine kinase inhibitors, or radiotherapy (except for extremities) 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 < 100000 platelets/mm3
    - 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.5.1.1Timepoint(s) of evaluation of this end point
    Analysis will be performed when 713 centrally confirmed progression events have occured.

    Changes related to Protocol Amendment 3, dated 08. August 2011:
    The analysis will be performed once the database for all treated patients
    (i.e. still blinded patients completed prior to the halt of the trial and
    patients unblinded after the halt of the trial) is locked.
    E.5.2Secondary end point(s)
    • Overall survival (key secondary endpoint)
    • Tumor response according to the modified RECIST criteria (objective
    tumor response, disease control, duration of disease control)
    • Incidence and intensity of adverse events according to the common
    terminology criteria for adverse events (CTCAE version 3.0)
    • Clinical improvement
    • Changes in safety laboratory parameters
    • Quality of life measured by standardized questionnaires (EQ-5D,
    EORTC QLQ C-30, EORTC QLQ LC 13)
    • Pharmacokinetics of BIBF 1120 (and of clinical relevant metabolites, if
    feasible)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival will be analysed either after about 48 months or when 1151 death events have occured. The other end points will also be analysed at this point in time and already before at the time point of analysis of the primary PFS-endpoint

    Changes related to Protocol Amendment 3, dated 08. August 2011:
    The analysis will be performed once the database for all treated patients
    (i.e. still blinded patients completed prior to the halt of the trial and
    patients unblinded after the halt of the trial) is locked.
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA161
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Croatia
    New Zealand
    European Union
    Argentina
    Australia
    Belarus
    Brazil
    Chile
    Ecuador
    Hong Kong
    India
    Korea, Republic of
    Malaysia
    Thailand
    Israel
    Macedonia, the former Yugoslav Republic of
    Mexico
    Moldova, Republic of
    Peru
    Russian Federation
    Serbia
    Singapore
    South Africa
    Taiwan
    Turkey
    Ukraine
    United States
    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 completed the first follow-up visit which should take place
    at least 28 days after end of active treatment (EOT).
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 520
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 780
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    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 Decision2010-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-08
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