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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2008-004171-21
    Sponsor's Protocol Code Number:L00070IN305B0
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-11
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2008-004171-21
    A.3Full title of the trial
    A phase III trial of vinflunine + capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial of Vinflunine Plus Capecitabine versus Capecitabine alone in Advanced Breast Cancer Patients who
    - were previously treated with an anthracycline or are resistant to an anthracycline
    and
    - who are taxane resistant
    A.4.1Sponsor's protocol code numberL00070IN305B0
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01095003
    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 SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 supportPIERRE FABRE MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointDr Jean-Claude VEDOVATO
    B.5.3 Address:
    B.5.3.1Street Address45, place Abel Gance
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+33149108070
    B.5.5Fax number+33149108331
    B.5.6E-mailjean.claude.vedovato@pierre-fabre.com
    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 Javlor
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Médicament
    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 nameJavlor
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVINFLUNINE
    D.3.9.1CAS number 162652-95-1
    D.3.9.4EV Substance CodeSUB00063MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 RoleComparator
    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
    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 nameXeloda
    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.3.8INN - Proposed INNCAPECITABINE
    D.3.9.1CAS number 154361-50-9
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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
    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 nameXeloda
    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.3.8INN - Proposed INNCAPECITABINE
    D.3.9.1CAS number 154361-50-9
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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
    Breast cancer metastatic
    E.1.1.1Medical condition in easily understood language
    Breast cancer that has spread to distant organs from the original tumor site (metastatic)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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
    Primary objective:
    - To compare between the 2 treatment arms the progression free survival.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - To compare between the 2 arms,
    1) the overall survival,
    2) the response rate and the disease control rate,
    3) the time to response and the duration of response,
    4) the overall safety,
    5) the impact of both treatments in the health-related quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:·
    - Patients must give written informed consent (personally signed and dated) before completing any study-related procedure.
    - Women with histologically or cytologically confirmed carcinoma of the breast.
    - Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy.
    - Patients must have received either one, two or three prior chemotherapy regimens including those administered in the neoadjuvant or adjuvant setting (neoadjuvant
    treatment followed by adjuvant treatment will count as a single regimen).
    - Prior treatments must have included both an anthracycline and a taxane.
    - Patients must have received a minimum cumulative dose of anthracycline (to be applied to >or = 180 mg/m² of doxorubicin or >or= 300 mg/m² of epirubicin) or be resistant to an anthracycline (to be applied to doxorubicin, epirubicin and liposomal doxorubicin) according to the following criteria:
    a) Tumour progression while on anthracycline or within 4 months of the last anthracycline dose given in the metastatic setting*; or
    b) Recurrence while on anthracycline or within 12 months of the last anthracycline
    dose when given in the adjuvant or neoadjuvant setting*

    * Note: in addition to these criteria, to be considered resistant, a patient must have received at least 2 cycles of an anthracycline-based regimen

    - Patients must be resistant to taxane therapy according to the following criteria:
    a) Tumour progression while on taxane or within 4 months of last taxane dose when given in the metastatic setting** or,
    b) Recurrence while on taxane or within 12 months of the last taxane dose when given in the adjuvant setting or neoadjuvant setting**.

    ** Note: in addition to these criteria, to be considered resistant, a patient must have received at least 2 cycles of a taxanebased regimen.

    - Prior anti-cancer hormone therapy is allowed but the patient must no longer be candidate for hormone therapy. The treatment must be terminated 2 weeks prior to randomisation.
    - Patients who have been treated with anti Her2 targeted therapy (e.g. trastuzumab, lapatinib) must have discontinued therapy at least 3 weeks prior to randomisation.
    - Prior radiation therapy is allowed to < 30% of the bone marrow and must be completed at least 4 weeks before randomisation.
    - Patient with measurable or non measurable disease according to revised RECIST guideline (version1.1).
    - Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of minor surgery, at least 3 weeks for major surgery.
    - Estimated life expectancy >or= 12 weeks.
    - Karnofsky performance score >or= 70 %.
    - Age >or= 21 years and < 80 years.
    - Adequate haematological function as defined by absolute neutrophil count (ANC) >or= 1.5 x 109/L, platelet count >or=100 x109/L and hemoglobin >or= 10 g/dL (within 7 days before first study treatment).
    - Adequate hepatic function as defined by: total bilirubin <or=1.5 x upper limit of normal (ULN), AST and ALT <or= 2.5 x ULN or <or= 5 x ULN in the case of liver metastases, alkaline phosphatase <or= 5 x ULN (within 7 days before first study treatment).
    - Adequate renal function as defined by a calculated creatinine clearance >or= 50 mL/min according to Cockroft-Gault formula (ml/min) = [(0.85)(140-age)(weight)]/[(0.81)(SrCr µmol/L)] (within 7 days before first treatment administration).
    - ECG without clinically relevant abnormality (within 7 days before first treatment administration).
    - Patients on coumarin-derivative must be on stable doses and have an International Normalized Ratio (INR) <or= 3 at the time of screening.
    - Women of childbearing potential must be using a medically accepted method of contraception (e.g barrier methods, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration.
    - The patient must have access to social insurance if applicable in the local regulations.
    - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
    E.4Principal exclusion criteria
    - Patients with known or with clinical evidence of brain metastasis or leptomeningeal involvement.
    - Patients with pulmonary lymphangitis or symptomatic pleural effusion (grade >or= 2) that results in pulmonary dysfunction requiring active treatment.
    - Patients having received any other experimental or anti-cancer therapy within 30 days before randomisation except hormone therapy.
    - History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years previously with no evidence of recurrence.
    - Patients with pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade > 1.
    - Patients having received > 3 regimens of chemotherapy
    - Prior therapy with capecitabine and/or vinca alkaloids (including vinflunine).
    - History of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or any contra indication to any of the study drugs.
    - Known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency.
    - Pregnant or breast feeding women.
    - Positive pregnancy test at inclusion.
    - Known history of HIV infection.
    - Inability to take and/or absorb oral medication including previous gastric surgery or any evidence of partial oesophageal, gastric, small or large bowel obstruction; gastrointestinal disorder that affect the absorption of capecitabine (malabsorption syndrome, 2/3 gastric resection and bowel resection).
    - Patients who have any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation
    - Prior bone marrow transplantation or autologous stem cell infusion following high-dose chemotherapy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the progression free survival.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Clinical and biological tumour assessment is mandatory every 6 weeks.
    • Bone X-rays, bone CT-scan or MRI to be repeated if positive at baseline and, as clinically indicated.
    • Bone scintigraphy should be performed in the following cases:
    - In those patients who had bone lesions at study entry: to
    document an overall complete response.
    - In all patients: at any time during study treatment in case of
    suspicion of progression due to skeletal related events
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • The tumour response rate in both arms,
    • The duration of response, disease control, time to treatment failure and time to first response in both arms,
    • The overall survival in both arms.
    E.5.2.1Timepoint(s) of evaluation of this end point
    as timepoints for primary endpoint evaluation
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Argentina
    Belarus
    Belgium
    Brazil
    Bulgaria
    Czech Republic
    Estonia
    France
    Hungary
    India
    Italy
    Mexico
    Poland
    Russian Federation
    Serbia
    South Africa
    Spain
    Switzerland
    Taiwan
    Ukraine
    United Kingdom
    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 study is defined as the date of the last progression observed in the study.
    However, in order to obtain an accurate estimation of the overall survival, an additional follow up period of approximately 18 months after the enrolment of the last patient will be required.
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 764
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 764
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 764
    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)
    See protocol
    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 Decision2010-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
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