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    The EU Clinical Trials Register currently displays   36818   clinical trials with a EudraCT protocol, of which   6079   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-005533-35
    Sponsor's Protocol Code Number:BO19734
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-05-24
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-005533-35
    A.3Full title of the trial
    An open-label, non-controlled study of bevacizumab in combination with cisplatin-gembitabine or carboplatin-paclitaxel, as first line treatment for patients with advanced or recurrent squamous non-small cell lung cancer (NSCLC).
    A.4.1Sponsor's protocol code numberBO19734
    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 SponsorF. Hoffmann La-Roche Ltd
    B.1.3.4CountrySwitzerland
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 nameAvastin
    D.3.2Product code RO4876646
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeRecominant humanised monoclonal antibody
    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
    Advanced or recurrent squamous non-small cell lung cancer in patients who are candidates for platinum-based chemotherapy and who have not received prior chemotherapy for metastatic or recurrent disease.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version PT
    E.1.2Level 8.1
    E.1.2Classification code 10061873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the feasibility of using bevacizumab plus cisplatingemcitabine
    or carboplatin-paclitaxel in patients with squamous
    NSCLC considered to be at major risk for pulmonary haemorrhage*,
    when using preventive measures** to reduce the risk of pulmonary
    haemorrhage.
    *Patients considered at major risk of pulmonary haemorrhage, when
    treated with bevacizumab, are defined as presenting with central tumours
    of any size or peripheral tumours ≥ 2 cm in their longest diameter that
    have not been previously irradiated.
    **The preventive measures to reduce the risk of pulmonary haemorrhage
    in patients treated with bevacizumab are:
    - exclusion of patients with history of ≥ grade 2 haemoptysis (bright red
    blood of at least ½ teaspoon) in the 3 months prior to inclusion in the
    study
    - a short course of radiation therapy 3 weeks prior to starting
    chemotherapy
    - delay of the first administration of bevacizumab to the second cycle of
    chemotherapy.
    E.2.2Secondary objectives of the trial
    To assess
    o Overall safety and tolerability
    o Best Overall Response (OR)
    o Duration of Response (DR)
    o Progression Free Survival (PFS)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Age ≥ 18 years.
    2. Willing and able to comply with the protocol as judged by the
    investigator.
    3. ECOG Performance Status of 0 or 1.
    4. Life expectancy of ≥ 12 weeks at the time of inclusion.
    5. Written informed consent obtained prior to any study specific
    procedure.
    6. Histologically or cytologically documented squamous NSCLC.
    Mixed tumours should be categorised according to the predominant
    cell type and the squamous cells must represent 50% or more of the
    cell components. Sputum cytology alone is not acceptable.
    Representative samples must be sent to Roche for central review.
    Results of the review are not required prior to inclusion and treatment
    of the patient.
    7. Stage IIIB with malignant pleural or pericardial effusion (i.e. patients
    who are not candidates for radical combined modality therapy or high-dose consolidation radiotherapy) OR stage IV (metastatic) OR
    recurrent disease.
    8. Patients who are candidates for treatment with platinum-based
    chemotherapy as first line chemotherapy for their disease.
    9. Patients in whom delaying the start of platinum-based chemotherapy
    by 3 weeks is acceptable in order to allow the administration of
    thoracic radiotherapy to lesions at risk of haemorrhage, when treated
    with bevacizumab. This criterion is applicable to the study population
    only.
    10.Measurable or evaluable disease. Baseline chest CT scans and any
    other chest imaging used for the assessment of lung lesions must be
    sent to Roche for central review. Results of the review do not have to
    be awaited for inclusion and treatment of the patients.
    11. Bronchoscopic assessment available at time of inclusion into the
    study to map and characterise endobronchial disease. Bronchoscopy
    to be performed within 2 months prior to inclusion into the study.
    12.Adequate renal function
    - Serum creatinine ≤ 1.25 x ULN or calculated creatinine
    clearance ≥ 50 mL/min
    - Urine dipstick of proteinuria <2+. Patients discovered to have
    ≥ 2+ proteinuria on dipstick urinalysis at baseline, should
    undergo a 24-hour urine collection and must demonstrate ≤ 1 g
    of protein/24 hr.
    13.Adequate haematological function:
    - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    - Platelet count ≥ 100 x 109/L
    - Haemoglobin ≥ 9 g/dL (may be transfused to maintain or exceed
    this level)
    - Prothrombin International Normalized Ratio (PT_INR) < 1.5;
    aPTT ≤1.5 x ULN.
    14.Adequate liver function
    - Total bilirubin < 1.5 x upper limit of normal (ULN)
    - AST, ALT < 2.5 x ULN in patients without liver metastases; < 5
    x ULN in patients with liver metastases.
    15. Free of co-morbid conditions, which could affect compliance with the
    protocol or the interpretation of results.
    16. If female, should not be pregnant or breast-feeding. Women with an
    intact uterus (unless amenorrhoeic for the last 24 months) must have a
    negative serum pregnancy test within 28 days prior to inclusion into
    the study. If a serum pregnancy test is not performed within 7 days
    prior to the first dose of bevacizumab, a confirmatory urine test
    (within 7 days prior to the first dose of bevacizumab) is required.
    E.4Principal exclusion criteria
    1. Mixed, non-small cell and small cell tumours or mixed
    adenosquamous carcinomas with a predominant non-squamous
    non-small or small cell component.
    2. Other primary tumours within the last 5 years before inclusion, except
    for adequately controlled limited basal cell, squamous carcinoma of
    the skin or carcinoma in situ of the cervix.
    3. Prior systemic anti-tumour therapy (chemotherapy, monoclonal
    antibody therapy or tyrosine kinase inhibitors).
    4. Prior radiotherapy for the treatment of the patients’s current stage of
    disease (stage IIIB with pleural or pericardial effusion, stage IV or recurrent disease). Patients who have received radiotherapy
    to the chest as a part of the treatment of an earlier stage of disease are
    eligible if the last fraction of radiotherapy was administered at least
    4 weeks prior to inclusion into the study. Palliative radiotherapy for
    the relief of metastatic bone pain allowed prior to inclusion
    into the study, providing
    - No more than 30% of marrow-bearing bone has been irradiated
    - The last fraction of radiotherapy has been administered within
    4 weeks prior to inclusion.
    5. Patients at high-risk for radiation pneumonitis (high V20 values) or
    unable to tolerate radiotherapy, as per investigator’s assessment. This
    criterion applies to the study population only.
    6. History of ≥ grade 2 haemoptysis (bright red blood of at least
    ½ teaspoon) in the 3 months prior to inclusion into the study.
    7. Evidence of tumour invading major blood vessels on imaging. The
    investigator or the local radiologist must exclude evidence of tumor
    that is fully contiguous with, surrounding, or extending into the lumen
    of a major blood vessel (e.g. pulmonary artery or superior vena cava).
    8. History or evidence of inherited bleeding diathesis or coagulopathy
    with the risk of bleeding.
    9. Current or recent (within 10 days of first dose of bevacizumab) use of
    aspirin (> 325 mg/day) or other NSAID with anti-platelet activity or
    treatment with dipyramidole, ticlopidine, clopidogrel (>75 mg/day)
    and cilostaz.
    10. Current or recent (within 10 days of first dose of bevacizumab) use of
    full dose oral or parenteral anticoagulants or thrombolytic agent for
    therapeutic (as opposed to prophylactic) purposes. At inclusion, exploratory population only.
    11. Increased risk of gastrointestinal perforation, hypertension, wound
    healing complications, thromboembolism or haemorrhage (for
    thromboembolism and haemorrhage increased risk relates to risks
    other than NSCLC).
    12. Clinically serious (as judged by the investigator) non-healing wound,
    peptic ulcer or bone fracture.
    13. History of abdominal fistula, gastrointestinal perforation, or
    intra-abdominal abscess within 6 months of inclusion.
    14. Evidence of spinal cord compression or brain metastases. A CT or
    MRI of the brain must be performed within 4 weeks prior to inclusion
    into the study.
    15.History or evidence, upon physical/neurological examination, of CNS
    disease unrelated to cancer, unless adequately treated with standard
    medical therapy.
    16.Major surgical procedure, open biopsy or significant traumatic injury
    within 28 days prior to inclusion, or anticipation of the need for major
    surgery during the course of the study treatment.
    17.Minor surgical procedures within 24 hours prior to inclusion.
    18. Uncontrolled hypertension (systolic > 150 mmHg and/or
    diastolic > 100 mmHg) or clinically significant (i.e. active)
    cardiovascular disease: CVA/stroke (≤ 6 months prior to inclusion),
    myocardial infarction (≤ 6 months prior to inclusion), unstable
    angina, New York Heart Association (NYHA) Grade II or greater
    congestive heart failure, or serious cardiac arrhythmia requiring
    medication.
    19.Active infection requiring i.v. antibiotics at inclusion.
    20.Women with an intact uterus (unless amenorrhoeic for the last
    24 months) not using effective, non-hormonal means of contraception. Men who do
    not agree to use effective contraception during the study and for a
    period of 60 days following the last administration of bevacizumab.
    21. Current or recent (within 30 days of inclusion) treatment with
    another investigational drug or participation in another investigational
    study.
    22. Evidence of any other disease, metabolic or psychological
    dysfunction, physical examination finding or clinical laboratory
    finding giving reasonable suspicion of a disease or condition that
    contraindicates the use of an investigational drug, or that may affect
    patient compliance with study routines, or places the patient at high
    risk from treatment related complications.
    23. Known hypersensitivity to any excipients of bevacizumab
    formulation or to the chosen chemotherapy regimen
    (cisplatin-gemcitabine or carboplatin-paclitaxel).
    24.Hypersensitivity to Chinese hamster ovary cell products or other
    recombinant human or humanised antibodies.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of grade ≥3 bevacizumab related pulmonary haemorrage in the study population.
    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 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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Treatment Feasibility
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.5The 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 Information not present in EudraCT
    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 final analysis of the primary endpoint, the rate of grade ≥ 3 bevacizumab-related
    pulmonary haemorrhages, will be performed after all patients have:
    - completed a maximum of 12 months of treatment with bevacizumab
    - or have stopped study treatment earlier because of disease progression or
    unacceptable toxicity
    - or have withdrawn from study treatment
    AND have been followed up for 60 days after their last administration of bevacizumab.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years1
    E.8.9.2In all countries concerned by the trial months11
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 70
    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 Decision2006-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    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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