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    Summary
    EudraCT Number:2005-004257-96
    Sponsor's Protocol Code Number:0002A3-200-EU
    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:2005-11-10
    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 number2005-004257-96
    A.3Full title of the trial
    Phase II Study with Symadex (C-1311) in Women with Metastatic Breast Cancer after Anthracycline and Taxane Failure
    A.4.1Sponsor's protocol code number0002A3-200-EU
    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 SponsorXanthus Pharmaceuticals Inc
    B.1.3.4CountryUnited States
    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 Information not present in EudraCT
    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 nameSymadex (C-1311)
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 138154.39.9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 to 800
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Breast Cancer
    MedDRA Classification
    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:
    - Evaluate the overall response rate (CR+PR) using RECIST criteria.
    E.2.2Secondary objectives of the trial
    - Determine the toxicity profile of Symadex (C-1311);
    - Determine the time to progression (TTP);
    - Determine duration of response;
    - Define the pharmacokinetic and metabolic clearance profile of Symadex (C-1311).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects must fulfill all of the following criteria to be eligible for study selection:

    a.) Women 18 years or older;
    b.) Histologically or cytologically confirmed breast cancer;
    c.) Metastatic breast cancer;
    d.) Subjects who relapsed within 12 months after completion of adjuvant or neoadjuvant therapy containing an anthracycline and a taxane or who have received at least one prior therapy for the treatment of metastatic disease.
    e.) Subjects must have received prior therapy with an anthracycline in either the adjuvant or metastatic setting;
    f.) Subjects must have received prior therapy with an taxane in either the adjuvant or metastatic setting;
    g.) Subjects may have been treated with hormonal and/or targeted therapies (such as trastuzumab), but such therapy must have been terminated prior to signing of the informed consent;
    h.) Prior chemotherapy treatment must have been terminated at least 3 weeks before the first administration of Symadex (C-1311);
    i.) Measurable disease according to RECIST criteria by radiographic methods (CT scan or MRI) and/or clinical examination;
    j.) ECOG Performance score less than or equal to 2 with an expected survival of at least 12 weeks;
    k.) Adequate renal function as evidenced by the following laboratory tests:
    Serum creatinine less than or equal to 1.5 x ULN;
    l.) Adequate hepatic function as evidenced by the following laboratory tests:
    Serum bilirubin less than or equal to 1.5 x ULN;
    Alkaline phosphatase less than or equal to 2.5 x ULN (less than or equal to 5 x ULN, in case of liver metastases);
    Serum AST or ALT less than or equal to 2.5 x ULN (less than or equal to 5 x ULN, in case of liver metastases);
    m.) Adequate hematologic status as evidenced by the following laboratory tests:
    Total WBC greater than or equal to 3.0 x 10^9/L (3,000/mm^3);
    Neutrophils greater than or equal to 1.5 x 10^9/L (1,500/mm^3);
    Platelets greater than or equal to 100 x 10^9/L (100,000/mm^3);
    Hemoglobin greater than or equal to 9.0 g/dL (9g/100 mL);
    n.) Negative pregnancy test (urine or blood) and an effective contraception method in women of childbearing potential. Reliable contraception must have been started 4 weeks prior to signing of the informed consent form and must be continued throughout the study and until at least four weeks after completion of study treatment. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives;
    o.) Previous radiotherapy is allowed if the end of the treatment was more than 4 weeks prior to the first administration of Symadex (C-1311). Acute radiation toxicities must have resolved. Tumor lesions which are situated in a previously irradiated field will not be considered measurable, unless radiation therapy was completed at least 6 months prior to obtaining screening measurements and the lesion(s) has/have appeared or increased in size since that radiation therapy;
    p.) Expected co-operation of the subject for the treatment and follow-up must be obtained and documented;
    q.) Written informed consent must be obtained and documented.
    E.4Principal exclusion criteria
    Subjects must not meet any of the following criteria to be eligible for study selection:

    a.) Myocardial infarction within 3 months of signature of the informed consent;
    b.) Unstable angina pectoris, cardiac insufficiency (NYHA Class III-IV), uncontrolled arrhythmia, or uncontrolled hypertension at the time of signature of the consent form;
    c.) Left Ventricular Ejection Fraction (LVEF) < 50%;
    d.) Absolute QTc interval prolongation > 450 msec;
    e.) Pre-existing neuropathy (motor or sensory) > grade 2;
    f.) Clinically significant abnormal hematological parameters other than those defined in the inclusion criteria;
    g.) Clinically significant abnormal biochemical parameters other than those defined in the inclusion criteria;
    h.) Known history or presence of brain or leptomeningeal metastases;
    i.) Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease;
    j.) Prior major surgery less than 4 weeks before the first administration of Symadex (C-1311). Subject must have recovered from prior surgery;
    k.) Subjects who received treatment with myeloid growth factors (i.e. G-CSF, GM-CSF) or blood transfusion within 2 weeks of obtaining the screening hematological blood work;
    l.) Pregnant or lactating women;
    m.) Clinically significant active infections;
    n.) Other prior malignancies, except for cured non melanoma skin cancer or curatively treated in situ carcinoma of the cervix or adequately treated malignancies for which there has been no evidence of activity for more than 5 years;
    o.) Other serious illness or medical condition;
    p.) Subjects with a history of a mental illness or condition which may interfere with the subjects’ ability to understand the requirements of the study;
    q.) Subjects who received an investigational new drug within 4 weeks of the first administration of Symadex (C-1311);
    r.) Any other known condition which in the investigator’s opinion would not make the subject a good candidate for the trial;
    s.) Known HIV positive or active hepatitis B or C.
    E.5 End points
    E.5.1Primary end point(s)
    Primary: Overall response rate (ORR) (complete response (CR) + partial response (PR)) using RECIST criteria.

    Secondary:Time to progression (TTP), duration of response.
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 Yes
    E.8.1.7.1Other trial design description
    The trial is of 2-stage design with P0 values and P1 values of 15% & 30% respectively.
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 Information not present in EudraCT
    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 the trial refers to the completion of the active phase of the study and the follow up for survival. When greater than 50% of the evaluable subjects have died, survival data for the remaining subjects will be censored as of the date the subject was last known to be alive.
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 Information not present in EudraCT
    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 2005-11-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 55
    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 Decision2006-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-09-12
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