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    Summary
    EudraCT Number:2007-002155-17
    Sponsor's Protocol Code Number:LAP105594
    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
    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 number2007-002155-17
    A.3Full title of the trial
    A phase II open label, multicenter study to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 positive circulating tumour cells or EGFR positive circulating tumor cells
    A.4.1Sponsor's protocol code numberLAP105594
    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 SponsorGlaxoSmithKline Research and Development Limited
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Tyverb
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline AG
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlapatinib
    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 milligram(s)
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 positive circulating tumour cells or EGFR positive circulating tumour cells
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a daily dose of lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours with HER-2 or EGFR positive circulating tumour cells.
    E.2.2Secondary objectives of the trial
    • To evaluate anti-tumour activitiy of lapatinib
    • To evaluate the safety of lapatinib
    • To determine the early response of lapatinib on proliferation and the MAP kinase cascade by PET in a substudy in patients with EGFR positive CTCs only.

    The translational research objective is to correlate response to lapatinib with HER-2 and EGFR protein levels and amplification evaluated on CTCs before starting treatment. A centralized review of the HER-2 status on the primary tumour will be performed retrospectively.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Imaging modulation of MAPkinase activity using [11C]choline and [18F]FLT PET.
    Version:03 Date: 2-Oct-2008

    The PET will be used to quantify response by calculating the change in PET uptake parameters like SUV (Standardised Uptake Value), Ki (constant for net irreversible uptake of tracer) and FRT (Fractional retention time). This will help in identifying early responders to treatment. PET will help in measuring MAP kinase activity and proliferation, both of which have been shown to be down regulated by lapatinib via its upstream blockade of EGFR and HER-2 receptor tyrosine kinases.
    E.3Principal inclusion criteria
    1. Signed written informed consent
    2. Female patients, age ≥ 18 years
    3. Histologically confirmed diagnosis of HER-2 negative (i.e. no gene amplification by FISH or IHC 2+ and no amplification by FISH or IHC 0/1+) infiltrating primary breast cancer.
    4. Evidence of EGFR positive circulating tumour cells or HER-2 positive (≥50% CTCs or FISH positive) in a peripheral blood sample taken at screening visit.
    5. Metastatic disease with at least one measurable lesion as per RECIST criteria classification
    6. No brain metastasis requiring local therapy. Stable or asymptomatic subjects are allowed.
    7. Availability of tumour block or at least six unstained 4 μm sections of the primary
    tumour to be sent to the central lab after eligibility confirmation for HER-2 central testing by FISH.
    8. Eastern Cooperative Oncology Group (ECOG) score for performance status 0 to 3
    9. Life expectancy > 12 weeks
    10. Adequate baseline haematologic, hepatic and renal function at screening visit.
    11. Normal left ventricular ejection fraction (LVEF) by echocardiogram or MUGA.
    12. Negative serum pregnancy test (only in childbearing potential female)
    13. Patients with reproductive potential needs consistent and correct use of adequate non-hormonal methods of birth control (barrier methods or intrauterine device)
    14. Previous treatment with anthracyclines and/or taxanes in the neo-adjuvant,
    adjuvant or advanced setting
    15. At least one line of treatment for metastatic disease
    E.4Principal exclusion criteria
    1. Any unstable systemic disease including active infections, significant cardiovascular disease, as well as myocardial infarction within the previous year, any significant hepatic (current active hepatic or biliary disease [with exception of patients with Gilbert's syndrome, asymtomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment]), renal or metabolic disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medication or that might affect the interpretation of the results or render the patient at high risk from treatment complications.
    2. Pregnant or lactating women
    3. Dementia, altered mental status, or any psychiatric condition that could prohibit the understanding or rendering of informed consent
    4. Lack of physical integrity of the upper gastrointestinal (GI) tract, poor absorption
    of the GI tract or inability to take oral medication
    5. Other co-existing malignancy or malignancies within the last 5 years with the
    exception of basal cell carcinoma or in-situ carcinoma
    6. Concurrent anti-cancer therapies (chemo or hormonal therapy) other than study drug
    7. Concurrent treatment with an investigational agent or participation in any investigational drug study within 4 weeks preceding treatment start
    8. Concurrent radiotherapy to the only target lesion. Concurrent bisphosphonates are allowed as long as this therapy has started before patient receives study medication.
    9. Previous treatment with anti HER-2 or anti-EGFR therapies
    10. Protocol specified treatment regimens that would be inappropriate for the
    management of the subject (See also concomitant medication Section 7.9).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the analysis is to evaluate the overall response rate (ORR)
    according to RECIST criteria.
    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 Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tumour biomarkers
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 No
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 62
    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)
    Normal standard of care
    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 Decision2008-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-20
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