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    The EU Clinical Trials Register currently displays   37227   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-001084-10
    Sponsor's Protocol Code Number:GEP 02/0801
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-10-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-001084-10
    A.3Full title of the trial
    A multicenter phase II clinical trial assessing the efficacy of the combination of lapatinib and capecitabine in patients with non pretreated brain metastasis from HER2 positive breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    LANDSCAPE
    A.4.1Sponsor's protocol code numberGEP 02/0801
    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 SponsorFNCLCC
    B.1.3.4CountryFrance
    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 Yes
    D.2.1.1.1Trade name Tyverb® 250mg
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Operations UK 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.3.1Product nameLapatinib
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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® 150mg
    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.3.1Product nameCapécitabine
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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: 3
    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® 500mg
    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.3.1Product nameCapécitabine
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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
    Patient with non penetrated brain metastasis from HER2 positive breast cancer.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006128
    E.1.2Term Brain metastases
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the objective response rate by volumetric analysis of the combination lapatinib and
    capecitabine on brain metastasis as assessed by MRI, in metastatic HER2 positive breast cancer
    patients, prior to any brain radiotherapy.
    E.2.2Secondary objectives of the trial
    - To document any toxicity evaluated by NCI-CTC-V3.0.
    - To assess the time to radiotherapy
    - To document the time to disease progression in the central nervous system (CNS).
    - To evaluate the overall response rate for extra-CNS disease.
    - To assess the clinical benefit (complete response [CR], partial response [PR], and stable disease [SD] for at least 6 months) for both CNS and extra-CNS disease.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - To evaluate serum proteomic and metabonomic markers as predictors of responses.
    - To evaluate the predictive value of Circulating Tumor Cells (CTC) on response.
    E.3Principal inclusion criteria
    1. Histologically confirmed invasive breast cancer with stage IV disease.
    2. HER-2 positive primary tumor, defined as : IHC3+, or IHC2+ and FISH positive.
    3. At least one measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI.
    4. At least two weeks from any specific breast cancer treatment (such as Trastuzumab,
    chemotherapy, immunotherapy/biological response modifiers, endocrine therapy and
    radiotherapy).
    5. Adequate hematologic function (ANC ≥ 1.0x109/L, platelets ≥ 100 000 ; Hb ≥ 10g/l), renal
    function (creatinine ≥ 1.5 UNL) and hepatic function (albumin ≥ 2.5 g/dL ;
    serum bilirubin ≤ 1.5x ULN unless due to Gilbert’s syndrome ; ASAT and ALAT ≤ 5x ULN if
    documented liver metastases or ≤ 3x ULN without liver metastases)
    6. Patients able to swallow and retain oral medication.
    7. At least 18 years old.
    8. ECOG Performance Status of 0 to 2.
    9. Life expectancy ≥ 3 months.
    10. Potentially reproductive patients must agree to use an effective contraceptive method while
    on treatment, beginning 2 weeks before the first dose of investigational product and for 28
    days after the final dose of investigational product for women. Males able to father a child
    must practice adequate methods of birth control or practice complete abstinence from
    intercourse from the first dose of investigational treatment until one week after the final
    dose of investigational treatment.
    11. Women of childbearing potential must have a negative serum pregnancy test within 14
    days of enrollment and/or urine pregnancy test 48 hours prior to the administration of the
    first study treatment.
    12. Patients must be affiliated to a Social Security System.
    13. Patient information and written informed consent form signed.
    E.4Principal exclusion criteria
    1) Previous whole brain radiotherapy (WBRT) or brain stereotactic radiotherapy.
    2) Planned or concurrent systemic treatment or radiation therapy for breast cancer (other that
    corticosteroid, biphosphonates or mannitol).
    3) Single brain metastasis which could be treated by surgery.
    4) Known contra-indication to MRI.
    5) Active concurrent malignancy. If there is a history of prior malignancy, the patient must be
    disease free for at least 10 years.
    6) Previous treatment with capecitabine, and/or lapatinib.
    7) Patients with other concurrent severe and/or uncontrolled medical disease which could
    compromise participation in the study, such as :
    a) infection,
    b) cardiac disease such as uncontrolled hypertension, congestive cardiac failure,
    ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one
    year, LVEF > grade 2,
    c) current active hepatic or biliary disease (with exception of subjects with Gilbert's
    syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per
    investigator assessment),
    d) renal disease,
    e) active GI tract ulceration, malabsorption syndrome, disease significantly affecting
    gastrointestinal function, or resection of the stomach or small bowel. Subjects with
    active, uncontrolled ulcerative colitis are also excluded,
    f) severely impaired lung function (spirometry and DLCO 50% or less of normal and O2
    saturation of 88% or less at rest on room air).
    8) Known dihydropyrimidine dehydrogenase (DPD) deficiency.
    9) Patients being treated with drugs recognized as being strong inhibitors or inducers of the
    isoenzyme CYP3A (Clarithromycin, Ketoconazole, Itroconazole, Voriconazole, Ritonavir, etc.)within the last 7 to 14 days prior to inclusion and/or during the study.
    10) Pregnant women, women who are likely to become pregnant or are breast-feeding.
    11) Patients with significantly altered mental status prohibiting the understanding of the study or
    with psychological, familial, sociological or geographical condition potentially hampering
    compliance with the study protocol and follow-up schedule; those conditions should be
    discussed with the patient before registration in the trial.
    12) Patients who received any other investigational drugs within the 30 days prior to the
    screening visit.
    13) Individual deprived of liberty or placed under the authority of a tutor.
    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 centralized 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).

    MRI for volumetric assessments will be performed every 6 weeks according to protocol specific acquisition guidelines (appendix 12). If a CNS PR or CR is assigned following an MRI scan of the brain, a follow-on disease assessment by MRI should be performed approximately 4 weeks after the criteria for response are first met, and then repeated once more, 4 weeks later.
    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 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 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 concerned15
    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 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 years3
    E.8.9.1In the Member State concerned months
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    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 Decision2008-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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