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    The EU Clinical Trials Register currently displays   36087   clinical trials with a EudraCT protocol, of which   5931   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-003195-19
    Sponsor's Protocol Code Number:ICORG06-36
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-06-11
    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 ConcernedIreland - HPRA
    A.2EudraCT number2007-003195-19
    A.3Full title of the trial
    A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) - IIIA Non- Small Cell Lung Cancer (NSCLC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare chemotherapy + bevacizumab and chemotherapy alone in patients with resected lung cancer (called non-small cell lung cancer)
    A.3.2Name or abbreviated title of the trial where available
    E1505
    A.4.1Sponsor's protocol code numberICORG06-36
    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 SponsorICORG
    B.1.3.4CountryIreland
    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 supportRoche
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICORG
    B.5.2Functional name of contact pointGlenn Webb
    B.5.3 Address:
    B.5.3.1Street Address60 Fitzwilliam Square
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code2
    B.5.3.4CountryIreland
    B.5.4Telephone number35316677211
    B.5.5Fax number35316697869
    B.5.6E-mailglenn.webb@icorg.ie
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameBevacizumab
    D.3.2Product code RO4876646
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) 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 Yes
    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 typeRecombinant 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
    Completely Resected Stage IB (≥4 cm)-IIIA Non-Small Cell Lung Cancer (NSCLC).
    E.1.1.1Medical condition in easily understood language
    Resected lung cancer (called non-small cell lung cancer)
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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
    Primary Objective
    To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (> 4 cm) - IIIA NSCLC.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    To evaluate disease free survival and toxicity with chemotherapy with or without
    bevacizumab used in the adjuvant setting in patients with resected stage IB
    (>/= 4 cm) - IIIA NSCLC.
    To perform analyses of tissue and blood to establish factors that predict for clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for
    resected early stage NSCLC.
    To determine whether smoking status is linked to outcome for patients with resected
    stage IB (>/= 4 cm) - IIIA NSCLC treated with chemotherapy with or without
    bevacizumab in the adjuvant setting.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.0 In order to be eligible for this trial, patients must have undergone complete resection of their non-small cell lung cancer (NSCLC) [stage IB (≥/= 4 cm) - IIIA (T2-3N0, T1-3N1, T1-3N2) prior to enrollment. (Refer to Appendix X for staging guidelines per AJCC 6th edition). Accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy. Resections by segmentectomy or wedge resection will not be accepted. Mediastinal lymph node sampling at specified levels is required pre-operative (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors). Please refer to Section 5 for specific details on lymph node level sampling requirements and resection criteria.
    2.0 Patients must be no less than 6 weeks (42 days) and no more (84 days) than 12 weeks post-thoracotomy at the time of randomization and must be adequately recovered from surgery.
    3.0 Age ≥ 18 years.
    4.0 ECOG performance status 0 or 1.
    5.0 Patients must not have received the following:
    5.1 Prior systemic chemotherapy at any time. Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 2 weeks prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.
    5.2 Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization. (Prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable.)
    6.0 Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer.
    7.0 Required laboratory values obtained within two weeks of randomization:
    ANC ≥ 1500 mm3
    Platelets ≥ 100,000/mm3
    Prothrombin time/INR ≤ 1.5
    Or, if patient is on therapeutic anticoagulation, prothrombin time/INR ≤ 3.0
    PTT ≤ institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be ≤ 1.5 x ULN
    Total Bilirubin ≤ 1.5 mg/dL
    SGOT (AST) < 5 x upper limit of normal (ULN)
    SGPT (ALT) < 5 x upper limit of normal (ULN)
    8.0 Patients must have adequate renal function as determined by the following tests within 2 weeks prior to randomization:
    Serum Creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
    Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be < 1000 mg (1g) for patient enrollment.
    9.0 Patients with a known history of myocardial infarction or other evidence of arterial thrombotic disease (angina) will be allowed on study only if they have had no evidence of active disease for at least 12 months prior to randomization.
    10.0 Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) will not be allowed on trial.
    11.0 Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk from bevacizumab. It is also unknown if these agents are excreted into breast milk.
    All females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy.
    12.0 All patients must have a documented BP with systolic < 150 and diastolic < 90 within 28 days of registration. Patients with known hypertension must be on a stable regimen of anti-hypertensive therapy.
    13.0 Patients who will receive pemetrexed/cisplatin therapy must meet all eligibility criteria as well as the following:
    13.1 Patients must NOT have squamous cell histology
    13.2 Calculated Creatinine Clearance must be obtained within 2 weeks of randomization and calculated CrCl must be ≥ 45mL/min using the standard Cockcroft and Gault formula (see Appendix III) or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate CrCl.
    E.4Principal exclusion criteria
    1.0 Patients less than 6 weeks (42 days) and more than 12 weeks (84 days) post-thoracotomy at the time of randomization and must be adequately recovered from surgery.
    2.0 Age ≤ 18 years.
    3.0 Patients who have received the following:
    3.1 Prior systemic chemotherapy at any time. (Please refer to principal inclusion criteria 5.1 for exception)
    3.2 Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization. (Prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable.)
    4.0 Patients with history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer.
    5.0 Required laboratory values not obtained within two weeks of randomization
    6.0 Inadequate renal function.
    7.0 Evidence of active myocardial infarction or other evidence of arterial thrombotic disease (angina) within 12 months prior to randomization.
    8.0 History of cerebral vascular accident (CVA) or transient ischemic attack (TIA).
    9.0 Pregnant or breast-feeding women due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk from bevacizumab. It is also unknown if these agents are excreted into breast milk.
    All females of childbearing potential who have not had a blood or urine test within 2 weeks prior to randomization to rule out pregnancy.
    10.0 Both fertile men and women not agreeing to use adequate contraceptive measures during study treatment and for at least 6 months after completion of bevacizumab.
    11.0 Any clinically significant ongoing, active or serious infection, symptomatic or uncontrolled congestive heart failure, symptomatic or uncontrolled cardiac arrhythmia or any other medical condition or psychiatric illness/social situations that would limit compliance with study requirements.
    12.0 History of bleeding diathesis or coagulopathy.
    13.0 History of hypertension not well controlled (controlled BP defined as systolic < 150 and diastolic < 90 mm Hg within 28 days of registration) on a stable regimen of anti-hypertensive therapy.
    14.0 Treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal). Patients must have stopped taking any of these agents at least 7 days prior to randomization.
    15.0 Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization OR core biopsy within 7 days prior to randomization.
    16.0 History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to randomization.
    17.0 Anticipated major surgical procedure(s) during the course of the study.
    18.0 Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
    19.0 Patients with ongoing post-operative hemoptysis (defined as bright red blood of ½ teaspoon or more).
    20.0 Patients who will recieve pemetrexed/cisplatin therapy must NOT have squamous cell histology.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    Survival - patients will be followed up for 10 years.
    E.5.2Secondary end point(s)
    - Disease free survival
    - analysis of tissue and blood to establish factors that predict for clinical outcome in patients receiving chemotherapy, with or without bevacizumab
    - Determine whether smoking status is linked to outcome
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Disease free survival - patients will be followed up for 10 years
    - analysis of tissue and blood - samples will be collected at the following time points: pre-study, Week 13, Week 25 and Month 15 (Arm B only)
    - Determine whether smoking status is linked to outcome - smoking surveys will be completed 3 monthly post registration up to 12 months
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned10
    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 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
    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
    A maximum of 10 years after the last patient is enrolled into the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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 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.1.2.1Number of subjects for this age range: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1500
    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 40
    F.4.2.2In the whole clinical trial 1500
    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)
    Patients will receive treatment for up to 1 year. Patients will be followed up for 10 years from registration or until death, whichever comes first.
    Patients will receive further treatment determined by their treating physicians as needed (recurrence, second primary cancers, etc).
    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 Decision2007-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-16
    P. End of Trial
    P.End of Trial StatusOngoing
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