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    The EU Clinical Trials Register currently displays   31099   clinical trials with a EudraCT protocol, of which   4845   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-011217-24
    Sponsor's Protocol Code Number:E7389-E044-203
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-08-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-011217-24
    A.3Full title of the trial
    A Phase 1b/2, Multicenter, Open-label, Dose-escalation and Confirmation Study of Eribulin in Combination with Capecitabine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to determine the most suitable dose of a combination of eribulin and capecitabine for use in late stage breast cancer patients
    A.4.1Sponsor's protocol code numberE7389-E044-203
    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 SponsorEisai 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 supportEisai Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Europe Ltd
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressMosquito Way
    B.5.3.2Town/ cityHatfield
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004408456761400
    B.5.5Fax number004408456761401
    B.5.6E-mailEUMedInfo@eisai.net
    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 Halaven
    D.2.1.1.2Name of the Marketing Authorisation holderEisai Europe 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 nameEribulin mesylate
    D.3.2Product code E7389
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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.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 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.3.4Pharmaceutical 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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Phase 1 - Advanced and/or metastatic cancer
    Phase 2 - Advanced and/or metastatic breast cancer
    E.1.1.1Medical condition in easily understood language
    Advanced breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10027477
    E.1.2Term Metastatic carcinoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dose-escalation cohorts (Phase 1b)
    • To determine the maximum tolerated dose (MTD) and dose-limiting
    toxicities (DLTs) of eribulin when administered in combination with
    capecitabine in two different schedules in subjects with advanced and/or
    metastatic cancer
    Dose-confirmation cohort (Phase 2)
    • To evaluate the efficacy of the combination of eribulin and capecitabine
    when administered at the MTD (determined during Dose-escalation) in
    the chosen dosing schedule from Phase Ib in female subjects with advanced
    and/or metastatic breast cancer
    E.2.2Secondary objectives of the trial
    Secondary objectives
    • To evaluate the safety, tolerability and toxicity profile of eribulin when given in combination with capecitabine
    • To explore the pharmacokinetic (PK) profiles, including evaluating the potential for drug-drug interaction, of eribulin, capecitabine and capecitabine metabolites when eribulin and capecitabine are given in combination
    Exploratory objectives
    • To explore the pharmacokinetic/pharmacodynamic (PK/PD) relationship
    between the combination of eribulin and capecitabine with neutropenia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects in Dose-escalation cohorts (Phase 1b):
    1) Histologically or cytologically confirmed cancer that is advanced and/or
    metastatic
    2) Resistant/refractory to approved therapies (defined as progressive
    disease during or within 6 months after the last anti-cancer therapy) or
    for whom single agent capecitabine at this dose level and schedule
    would be a reasonable treatment option in the opinion of the investigator
    3) Eastern Cooperative Oncology Group (ECOG) performance status (PS)
    ≤ 2
    4) For subjects that previously received capecitabine all capecitabine
    related toxicities must have completely resolved.

    Subjects in Dose-confirmation cohorts (Phase 2):
    1) Histologically or cytologically confirmed carcinoma of the breast that is
    advanced and/or metastatic
    2) Received up to three prior chemotherapy regimens in any setting
    (sequential neo-adjuvant/adjuvant treatment counting as one regimen)
    3) Chemotherapy regimens must have included an anthracycline (unless
    anthracycline containing chemotherapy is inappropriate) and a taxane,
    either in combination or in separate regimens
    4) No prior treatment with capecitabine in any setting
    5) At least one lesion of ≥ 1.5cm in longest diameter for non-lymph nodes
    and ≥1.5cm in shortest diameter for lymph nodes which is serially
    measurable according to the Response Evaluation Criteria in Solid
    Tumors (RECIST) version 1.1
    6) ECOG-PS 0 or 1

    General inclusion criteria:
    1) Adequate bone marrow function:
    absolute neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin ≥ 10.0 g/dL
    (this may have been corrected by growth factor or transfusion), and
    platelet count ≥ 100 x 109/L
    2) Adequate liver function as evidenced by bilirubin ≤ 1.5 times the upper
    limits of normal (ULN) and alkaline phosphatase, alanine
    aminotransferase (ALT), and aspartate aminotransferase (AST)
    ≤ 3 x ULN (in the case of liver metastases ≤ 5 x ULN)
    3) Adequate renal function as evidenced by calculated creatinine clearance
    ≥ 50 mL/min as per the Cockcroft-Gault formula or radioisotope
    measurement
    E.4Principal exclusion criteria
    1) Suspected dihydropyrimidine dehydrogenase (DPD) deficiency
    2) Prior participation in an eribulin clinical study, even if not assigned to
    eribulin treatment
    3) Pre-existing neuropathy > Grade 2
    4) Subjects with brain or subdural metastases are not eligible, unless they
    have completed local therapy and have discontinued the use of
    corticosteroids for this indication for at least 4 weeks before starting
    study treatment. Any symptoms attributed to brain metastases must be
    stable for at least 4 weeks before starting study treatment; radiographic
    stability should be determined by comparing contrast-enhanced
    computed tomography (CT) or magnetic resonance imaging (MRI) brain
    scan performed during screening to a prior scan performed at least 4
    weeks earlier.
    5) Electrocardiogram (ECG) with QTc interval > 470 msec
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint Dose-Escalation:
    A dose limiting toxicity (DLT) is defined as any of the following toxicities considered to be
    related to study treatment:
    • Neutropenia Grade 4 that lasts ≥ 7 days
    • Neutropenia Grade 3 or 4 complicated by fever and/or infection
    (ANC < 1.0 x 109/L, fever ≥ 38.5°C)
    • Thrombocytopenia Grade 4
    • Thrombocytopenia Grade 3 complicated by bleeding and/or requiring
    platelet or blood transfusion
    • Non-hematological toxicity Grade 3 or higher (excluding Grade 3
    nausea, and Grade 3 or 4 vomiting or diarrhea in subjects who have not
    received optimal treatment with anti-emetic and/or anti-diarrheal
    medication; also excluding any laboratory abnormalities without clinical
    symptoms)
    • Delayed recovery from treatment-related toxicity resulting in a dose
    delay > 14 days
    • Failure to administer ≥ 75% of the planned study drugs during Cycle 1
    as a result of ≥ Grade 2 treatment-related toxicity that constitutes an
    increase of ≥ 2 grades from baseline
    The maximum tolerated dose (MTD) is defined as the highest dose level at which no more than one out
    of six subjects experience DLT.
    Efficacy:
    Tumor response as assessed by the investigator will be based on RECIST
    version 1.1 in all subjects. Tumor assessments (CT/MRI scans, photographs)
    will be performed within 28 days prior to the start of study treatment and
    every 6 weeks (within week 6) from first study drug dose. Bone scans will be
    performed at baseline and every 18 weeks (within week 18) and at the time
    of confirmation of response for breast cancer subjects in the Doseconfirmation
    part of the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The maximum tolerated dose (MTD) is defined as the highest dose level at which no more than one out
    of six subjects experience DLT.
    E.5.2Secondary end point(s)
    To evaluate the safety, tolerability and toxicity profile of eribulin when given in combination with capecitabine
    To explore the pharmacokinetic (PK) profiles, including evaluating the
    potential for drug-drug interaction, of eribulin, capecitabine and
    capecitabine metabolites when eribulin and capecitabine are given in combination
    E.5.2.1Timepoint(s) of evaluation of this end point
    At end of trial
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose escalation study (phase 1b)
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Different dosage schedule
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Russian Federation
    United Kingdom
    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
    End of the Trial is the date of 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 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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 76
    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)
    After a subject has ended participation in the trial, the subject's doctor will advise what the most appropriate subsequent treatment is based on the subject's type and stage of cancer.
    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 Decision2009-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
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