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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-000113-38
    Sponsor's Protocol Code Number:UCL/05/177
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-12-07
    Trial results Removed from public view
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-000113-38
    A.3Full title of the trial
    A randomised phase II double blind placebo controlled trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, erlotinib) in patients with advanced non-small cell lung cancer (NSCLC) with multiple brain metastases
    A.3.2Name or abbreviated title of the trial where available
    TACTIC
    A.4.1Sponsor's protocol code numberUCL/05/177
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number31916843
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    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 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.2.1.1.1Trade name Tarceva 25 mg, 100 mg & 150 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTarceva
    D.3.2Product code OSI-774
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 placeboFilm-coated tablet
    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
    Advanced non-small cell lung cancer with multiple brain metastases
    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
    To estimate the effect on neurological progression-free survival at 2 months (n = neurological progression or death) of WBRT, with concomitant Tarceva compared to WBRT alone in patients with advanced NSCLC with multiple brain metastases
    E.2.2Secondary objectives of the trial
    (i) Toxicity
    (ii) Response rate
    (iii) Quality of life
    (iv) Change in Performance Status
    (v) Steroid dosing
    (vi) Sites of progression (cranial or extracranial) will also be recorded.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Histologically or cytologically confirmed NSCLC. A biopsy of metastatic disease in the brain is not required for study enrolment.
    b) Patients with newly diagnosed single or multiple brain metastases in whom immediate chemotherapy is not required for palliation of systemic extra-cranial disease. Patients with a solitary brain metastasis are only eligible for the trial providing they are not suitable for stereotactic radiotherapy or surgical resection.
    c) Diagnosis of brain metastases must be confirmed on MRI or contrast CT scan.
    d) Able to start treatment within 4 weeks of the baseline measurement scans of the brain, chest & abdomen.
    e) Patients with post-craniotomy incomplete resection will be permitted.
    f) No prior cranial radiotherapy.
    g) ≥ 28 days from any chemotherapy to Day 1 of trial treatment.
    h) Clinician certain of the role of WBRT.
    i) Glasgow Coma Score ≥14.
    j) Karnofsky performance status ≥ 70, RTOG RPA class I and II (modified by age to <76 years).
    k) Maximum of 3 sites (organ systems) of extracranial metastases (not including lung primary).
    l) Age > 18 years and < 76 years.
    m) Able to take oral medication.
    n) Adequate renal function, serum creatinine <1.5 x ULN and C&G GFR >40ml/min, absence of evidence of acute renal failure.
    m) Adequate liver function, ALT or AST < 2 x ULN without liver metatases or < 5 x ULN with liver metatases; serum bilirubin < 2 x ULN.
    o) Willing to use effective contraception, if of reproductive potential, whilst on trial drug and for at least 2 weeks after completing trial drug. (Women of childbearing potential must have a negative pregnancy test performed by a healthcare professional prior to randomisation.)
    p) Willing and able to give informed consent.
    q) Willing to participate in the biological study.
    r) Carer able and willing to participate.
    s) Patient and carer with access to telephone and willing to respond to telephone interview.


    E.4Principal exclusion criteria
    a) Presence of a solitary brain metastasis suitable for stereotactic radiosurgery or surgical resection.
    b) Patients who require immediate chemotherapy for symptom control.
    c) Clinician certain that WBRT will NOT be of benefit.
    d) Clinician uncertain of the role of WBRT.
    e) Previous treatment with any EGFR anti-cancer therapy (e.g. Tarceva, Iressa or Cetuximab).
    f) Previous treatment for brain metastases (radiosurgery, radiotherapy or chemotherapy) - however prior radiotherapy or surgery to the primary tumour and/or systemic treatment to metastatic sites of disease is acceptable.
    g) Glasgow Coma Score < 14.
    h) Pregnant or lactating women.
    i) Evidence of other significant laboratory finding or concurrent uncontrolled medical illness which in the opinion of the investigator would interfere with protocol treatment or results comparison or render the subject at high risk from treatment complications. For example:
    - Severe uncontrolled infection
    - Cardiovascular: unstable angina, myocardial infarction within 1 month
    - Gastro-intestinal: uncontrolled inflammatory bowel disease (e.g. Crohn’s or ulcerative colitis)
    - Hepatic: serum bilirubin ≥ to 2x upper limit of normal (ULN), serum transaminases ≥ 2x ULN in the absence of liver metastases or ≥ 5x ULN with liver metastases
    - Renal: acute renal failure, serum creatinine ≥1.5 x ULN.
    j) Other previous or current malignant disease likely to interfere with protocol treatment or comparisons.
    k) Current treatment with Cox II inhibitor.
    l) > 75 years of age.
    E.5 End points
    E.5.1Primary end point(s)
    Neurological progression-free survival at 2 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 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 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 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.8.5The 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 Information not present in EudraCT
    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
    For the purposes of this protocol the end of trial is defined as the date the last patient completes two months of treatment. This coincides with the primary endpoint of neurological progression free survival at 2 months. However, given the very limited treatment options for this patient population, patients may continue to take the study drug for up to 24 months. All patients will be followed until death.
    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 months0
    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 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 state144
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 144
    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 Decision2006-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-11
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