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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   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:2005-003944-68
    Sponsor's Protocol Code Number:EGF105084
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-21
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-003944-68
    A.3Full title of the trial
    A Phase II Study of Lapatinib for Brain Metastases in Subjects with ErbB2-Positive Breast Cancer Following Trastuzumab based Systemic Therapy and Cranial Radiotherapy
    A.4.1Sponsor's protocol code numberEGF105084
    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 R&D Ltd
    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 holderGlaxo Group Ltd
    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 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.IMP: 2
    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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.4Pharmaceutical 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.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Progressive symptomatic or asymptomatic ErbB2 overexpressing breast cancer brain metastases.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the CNS objective response rate to monotherapy lapatinib in subjects with progressive brain metastases from ErbB2-overexpressing breast cancer. A CNS objective response is defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of brain magnetic resonance imaging (MRI), provided there is no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of tumor-related neurological signs and symptoms (NSS).
    E.2.2Secondary objectives of the trial
    To determine improvement in neurological signs and symptoms (NSS),
    measured using the Neurological Examination Worksheet
    • To determine the percentage of subjects who obtain a CNS objective response or
    improvement in baseline NSS
    • To determine duration of CNS objective response
    • To determine percentage of subjects with CNS disease control (complete
    response, partial response or stable disease) at 6 months of lapatinib therapy
    • To determine time to progression at any site
    • To determine overall survival (OS)
    • To describe and summarize site of first progression and cause of death
    • To determine the qualitative and quantitative toxicities associated with oral
    lapatinib, given at a dose of 750 mg BID.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent;
    2. Age ≥ 18 years old;
    3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
    4. Life expectancy of at least 12 weeks;
    5. Subjects must have histologically or cytologically confirmed invasive breast cancer, with Stage IV disease;
    6. ErbB2 overexpressing breast cancer, defined as 3+ staining by
    immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with ErbB 2
    gene amplification by FISH, or ErbB 2 gene amplification by FISH alone (in
    subjects whose tumor blocks were not assessed by IHC). Subjects with tumors that
    are 2+ by IHC but negative by FISH assay are ineligible;
    7. At least one measurable lesion in the brain, defined as any lesion ≥ 10mm in longest dimension on T1-weighted, gadolinium-enhanced MRI. Measurable brain lesions should not have been treated with prior stereotactic radio surgery (SRS); an
    exception being a brain lesion whose longest linear dimension increased ≥ 50%
    following SRS and whose absolute longest dimension now measures ≥ 15mm;
    8. Prior treatment of brain metastases with WBRT and/or SRS;
    9. Unequivocal evidence of new and / or progressive lesions in the brain on an imaging study; Note: Subjects with progressive brain lesions are not required to meet RECIST criteria for CNS progression in order to be eligible for this study.
    10. Prior treatment with trastuzumab, either alone or in combination with chemotherapy is required. Trastuzumab will be discontinued at least 2 weeks prior to enrollment on study;
    11. Cardiac ejection fraction within institutional range of normal as measured by
    echocardiogram. MUGA scans will be accepted in cases where an echocardiogram
    cannot be performed or is inconclusive;
    12. At least 2 weeks since prior radiotherapy, last chemotherapy, immunotherapy,
    biologic therapy, or hormonal therapy for cancer, and sufficiently recovered or
    stabilized from side effects associated with prior therapy. Concurrent treatment with
    bisphosphonates is permitted;
    13. At least 3 weeks since major surgical procedures;
    14. Able to swallow and retain oral medications;
    15. Female subjects with child bearing potential or male subjects able to father a child must be completely abstinent from intercourse or use acceptable methods for birth control during the course of the study;
    16. Subjects must complete all screening assessments as outlined in the protocol;
    17. Subjects must have normal organ and marrow function as defined below:
    SYSTEM LABORATORY VALUES
    Hematologic
    ANC (absolute neutrophil count) ≥1.0 x 109/L
    Hemoglobin ≥ 9 g/dL (after transfusion if needed)
    Platelets ≥ 50 x 109/L
    Hepatic
    Albumin ≥ 2.5 g/dL
    Serum bilirubin ≤ 1.5x ULN unless due to Gilbert’s syndrome
    AST and ALT ≤ 5x ULN if documented liver metastases
    ≤ 3x ULN without liver metastases
    Renal
    Serum Creatinine ≤ 2.0 mg/dL
    or
    Calculated Creatinine Clearance* ≥ 25 mL/min
    *Calculated by the Cockcroft and Gault Method
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria
    apply:
    1. Subjects who have had chemotherapy or radiotherapy within 2 weeks prior to
    entering the study or who have unresolved or unstable, serious toxicity from prior
    administration of another investigational drug and/or of prior cancer treatment;
    2. Concurrent treatment with an investigational agent or participation in another
    treatment clinical trial;
    3. Subjects receiving concurrent chemotherapy, radiation therapy, immunotherapy,
    biologic therapy (including an ErbB1 and/or ErbB2 inhibitor), or hormonal therapy
    for treatment of their cancer. Hormone therapy for ovarian suppression which has
    been used for > 6 months, during which time there has been disease progression in
    the brain, is allowed. Concurrent treatment with bisphosphonates is allowed;
    4. Subjects with leptomeningeal carcinomatosis as the only site of CNS involvement;
    5. History of allergic reactions attributed to compounds of similar chemical
    composition (quinazolines) to lapatinib;
    6. Concurrent treatment with medications listed in Section 8.2, Prohibited Medications;
    7. Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled
    ulcerative colitis are also excluded;
    8. History of immediate or delayed hypersensitivity reaction to gadolinium contrast
    agents, or other contraindication to gadolinium contrast;
    9. Other known contraindication to MRI, such as a cardiac pacemaker, implanted
    cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or
    shrapnel;
    10. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety;
    11. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
    12. Pre-existing severe cerebral vascular disease, such as stroke involving a major
    vessel, CNS vasculitis, or malignant hypertension;
    13. Active cardiac disease, defined as one or more of the following:
    • History of uncontrolled or symptomatic angina
    • History of arrhythmias requiring medications, or clinically significant, with the
    exception of asymptomatic atrial fibrillation requiring anticoagulation
    • Myocardial infarction < 6 months from study entry
    • Uncontrolled or symptomatic congestive heart failure
    • Ejection fraction below the institutional normal limit
    • Any other cardiac condition, which in the opinion of the treating physician,
    would make this protocol unreasonably hazardous for the patient
    14. Uncontrolled infection;
    15. History of other malignancy, except for curatively treated basal cell carcinoma or
    squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. Subjects
    with other malignancies who have been disease-free for at least 5 years are eligible;
    16. Pregnant or lactating females;
    17. No prior lapatinib therapy;
    18. Any other investigational drugs from 30 days or five half lives, prior to the first dose of lapatinib until 30 days after the last dose of lapatinib.
    E.5 End points
    E.5.1Primary end point(s)
    CNS objective response rate is the primary study endpoint, where CNS objective
    response is defined as either a CR or PR, assessed by volumetric analyses of magnetic resonance imaging (MRI), provided there is no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of neurological signs and symptoms (NSS).
    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 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 Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA23
    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 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
    Lapatinib Monotherapy Study completion as indicated below.
    •Subject has received lapatinib for one year.
    •Subject is no longer receiving treatment with lapatinib and has completed one year of follow-up;
    •Subject has expired prior to completing one year of study follow-up.
    Lapatinib + Capecitabine view protocol for further information.
    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 months6
    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 months6
    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 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 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 2005-12-21. Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 220
    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 Decision2006-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
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