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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   37212   clinical trials with a EudraCT protocol, of which   6120   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).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2007-001826-28
    Sponsor's Protocol Code Number:BL-2007-02
    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:2007-08-01
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2007-001826-28
    A.3Full title of the trial
    A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after firrst-line chemotherapy in patients with HER1 and/or HER2 over expressing locally advanced or metastatic bladder cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial looking at lapatinib versus a placebo for people with bladder cancer that has spread to other parts of the body.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberBL-2007-02
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN35418671
    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 SponsorQueen Mary University 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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for Experimental Cancer Medicine
    B.5.2Functional name of contact pointCharlotte Rofe
    B.5.3 Address:
    B.5.3.1Street AddressLower Ground Floor, Old Anatomy Building
    B.5.3.2Town/ cityCharterhouse Square, London
    B.5.3.3Post codeEC1M 6BQ
    B.5.3.4CountryUnited Kingdom
    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. name Tyverb
    D. of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namelapatinib
    D.3.2Product code GW572016
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.1CAS number 388082-78-8
    D.3.9.2Current sponsor codeGW572016
    D.3.9.3Other descriptive nameLapatinib ditosylate monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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
    D.8 Placebo: 2
    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
    The medical condition being investigated in this trial is locally advanced or metastatic urological cancer. The tumour must overexpress HER1 and/or HER2 gene.
    E.1.1.1Medical condition in easily understood language
    Bladder cancer that has spread to other parts of the body or to nearby tissues in the area.
    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 10005012
    E.1.2Term Bladder cancer stage IV
    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 main objective of the study is to compare progression-free survival (PFS) in patients with HER1 and/or HER2 over expressing stage IV bladder cancer who have been randomised to maintenance therapy with lapatinib or placebo following first-line chemotherapy
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to:

    • Compare overall survival (OS) between the two groups.
    • Evaluate the safety and tolerability of the regimens in this population
    • Assess and compare quality of life between the 2 groups
    • Assess best response rate (RR) between the two groups
    • Investigate the correlation of outcome with baseline characteristics of different HER1-4 intensities of overexpression
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Histologically confirmed metastatic or locally advanced transitional cell carcinoma of the urothelium.
    •Stage IV disease at entry of the study
    •Able to commence study treatment within 10 weeks of completing chemotherapy
    •HER1-positive (2+ or 3+ intensity on immunohistochemical staining (IHC) and/or amplification of the HER1 gene on fluorescence in situ hybridization (FISH)) and/or HER2-positive (2+ or 3+ intensity on immunohistochemical staining (IHC) and/or amplification of the HER2 gene on FISH)
    •Objective response or stable disease following at least 4 and no more than 8 cycles of first-line chemotherapy. The chemotherapy regimen includes any widely accepted regimen for bladder cancer. Patients who do not receive cisplatin remain eligible. Dose reduction and delays in treatment between cycles are acceptable.
    •Adequate haematological function (ANC ≥1.0 x 109/l, Hb ≥ 8.0 g/dL and platelet count to ≥75 x 109/l).
    •Adequate liver function tests (ALT/AST < 2 x ULN, bilirubin level < 1.5 x ULN).
    •Normal cardiac function with a left ventricular ejection fraction of at least 50% (as assessed by quantitative echocardiogram)
    •ECOG performance status 0-3
    •Age ≥ 18 years
    •If the patient is of childbearing potential, she agrees to: comply with effective contraceptive measures, has been using adequate contraception since the last menses, will use adequate contraception during the study, and has a negative pregnancy test within one week of study entry
    •Written informed consent prior to admission to this study
    E.4Principal exclusion criteria
    •Patients who progress by RECIST on first-line chemotherapy and require 2nd line chemotherapy. Patients with progression of disease who do not fulfil RECIST criteria for PD and do not require 2nd line therapy are eligible. The original pre-treatment CT and post treatment CT should be compared to assess response.
    •More than one line of prior chemotherapy for metastatic or locally advanced disease (Neoadjuvant/adjuvant chemotherapy is acceptable).
    •Serum creatinine concentration > 3.0 x ULN and/or creatinine clearance <30 ml/min (using EDTA or Cockcroft and Gault)
    •Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
    •Previous treatment with study medication and/or known hypersensitivity to the study medication.
    •Past or current history of other neoplasms, except for:
    o Any non life-threatening tumours that have been curatively treated.
    •Significant cardiac disease, including angina pectoris, severe cardiac arrhythmia requiring medication, severe conduction abnormalities, clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, poorly uncontrolled hypertension (resting diastolic blood pressure >115 mmHg), prior myocardial infarction, CHF, or other cardiomyopathy
    • Serious intercurrent medical or psychiatric illness, including serious active infection
    • Concurrent treatment with other experimental drugs.
    • Less than 4 cycles or more than 8 cycles of standard chemotherapy
    •Greater than 10 week delay from finishing 1st line chemotherapy to starting maintenance therapy.
    • Pregnant or nursing women
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the trial is to compare PFS for patients randomised to receive placebo versus those randomised to lapatinib.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This will occur after 196 events have been reached.
    E.5.2Secondary end point(s)
    The secondary objectives
    E.5.2.1Timepoint(s) of evaluation of this end point
    This will occur after the last patient has taken the last study dose to allow for all safety reporting to be complete.
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 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.8.2.4Number 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 concerned35
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 No
    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 end of trial is defined as thirty days after the last patient has taken the last study dose to allow for all safety reporting.
    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 months9
    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.1.2.1Number of subjects for this age range: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state221
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 221
    F.4.2.2In the whole clinical trial 221
    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)
    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 Decision2007-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-09
    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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