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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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:2007-005209-23
    Sponsor's Protocol Code Number:CA163139
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-06
    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 ConcernedGreece - EOF
    A.2EudraCT number2007-005209-23
    A.3Full title of the trial
    Randomized Phase II of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects with Triple Negative (ER, PR, Her2 negative) Locally Advanced non-resectable and/or Metastatic Breast Cancer
    A.4.1Sponsor's protocol code numberCA163139
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 No
    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 nameIxabepilone
    D.3.2Product code BMS-247550
    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.3.8INN - Proposed INNIxabepilone
    D.3.9.1CAS number 219989-84-1
    D.3.9.2Current sponsor codeBMS-247550-01
    D.3.9.3Other descriptive nameEpothilone B analog
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 No
    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 nameIxabepilone
    D.3.2Product code BMS-247550
    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.3.8INN - Proposed INNIxabepilone
    D.3.9.1CAS number 219989-84-1
    D.3.9.2Current sponsor codeBMS-247550-01
    D.3.9.3Other descriptive nameEpothilone B analog
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    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 nameCetuximab
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNCetuximab
    D.3.9.1CAS number 205923-56-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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, FIRST LINE
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006187
    E.1.2Term 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 estimate the response rate of ixabepilone monotherapy, and the combination of
    ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (ER, PR, Her2 negative) locally advanced non-resectable and/or metastatic breast cancer.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to estimate the progression-free survival, time to response and duration of response in both arms and to determine the safety and tolerability of ixabepilone monotherapy and ixabepilone/cetuximab in this subject population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent

    2) Target Population
    a) Histologic or cytologic confirmed diagnosis of invasive adenocarcinoma
    originating in the breast with evidence of locally advanced non-resectable and/or
    metastatic disease.
    b) At least one target lesion per RECIST criteria.
    c) Previously radiated area(s) must not be the only site of disease.
    d) Subjects must have breast cancer not overexpressing or amplify Her2:
    • IHC 0 and 1+ tumors are allowed into the study unless FISH is positive.
    • IHC 2+ tumors are allowed into the study only if FISH is negative. Her2 status will be determined based on local measurements that have been done at diagnosis (based on the primary tumor), or based on re-biopsy. Measurements of the primary tumor will not be considered if a valid measurement of the metastasis is available.
    e) Subjects must have breast cancer that does not express any hormone receptors
    (ER and/or PR). Hormone receptor status will be determined based on local measurements that have been done at diagnosis (based on the primary tumor), or
    based on re-biopsy. Measurements of the primary tumor will not be considered if a valid measurement of the metastasis is available.
    f) Subjects must have had prior adjuvant or neoadjuvant anthracycline-based chemotherapy
    g) Prior endocrine therapy in (neo)adjuvant, recurrent or metastatic setting is allowed, but this must have been discontinued at least 2 weeks prior to
    randomization.
    h) Karnofsky Performance Status (PS) of 80-100 (or Eastern Cooperative Oncology Group, PS of 0-1) (See Protocol Appendix 3).
    i) Estimated life expectancy of at least 12 weeks.
    j) Recovery (except for alopecia, fatigue and grade 1 neuropathy) from recent
    therapy, including chemotherapy, immunotherapy, biological therapy or investigational product. Any such therapy must have been completed at least 3
    weeks prior to randomization.
    k) Recovery from recent surgery; at least one week must have elapsed from minor surgery (e.g. placement of venous access device or fine needle aspiration), at least
    4 weeks from major surgery.
    l) Recovery from radiation; at least one week from focal/palliative radiation therapy and 3 weeks from any therapeutic radiation.
    m) Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating center

    3) Age and Sex
    a) Women 18 years of age or older. Male subjects will be excluded from this trial. Due to the small size population of this trial the expected number of male subjects enrolled would be such that no clinically significant information would be
    collected.
    E.4Principal exclusion criteria
    1) Sex and Reproductive Status
    a) WOCBP who are unwilling or unable to use an acceptable method to avoid
    pregnancy for the entire study and for up to 12 weeks after the last dose of any study drug.
    b) Women who are pregnant or breastfeeding
    c) Women with a positive pregnancy test on enrollment or prior to investigational product administration.

    2) Target Disease Exceptions
    a) Evidence of baseline sensory or motor neuropathy > Grade 1.
    b) Any current or previous history of brain and/or leptomeningeal metastases
    including evidence of cerebral edema by computerized tomography (CT) or
    magnetic resonance.
    c) Prior radiation must not have included ≥ 30% of major bone marrow containing
    areas (pelvis, lumbar spine).
    d) Subjects who have received prior systemic therapy for metastatic disease.
    e) Tumors excluded from the study are the ones that are FISH positive or IHC 3+.

    3) Medical History and Concurrent Diseases
    a) Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy.
    b) Any concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. Subjects with a history of previous malignancies but without evidence of disease for ≥ 5 years will be allowed to enter the trial.
    c) Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart failure, myocardial infarction) within 6 months prior to study entry.
    d) Prior history of high dose chemotherapy with bone marrow transplant or
    peripheral blood stem cell transplant within the previous 2 years.
    e) Prior treatment with an epothilone (or epothilone analogue) or an EGFR inhibitor.

    4) Physical and Laboratory Test Findings
    a) Absolute Neutrophil Count (ANC) ≤ 1500/mm³,
    b) Hemoglobin ≤ 9 g/dL,
    c) Platelets < 100,000/mm³
    d) Total bilirubin > 1.0x times the upper limit of normal (ULN)
    e) AST or ALT ≥ 2.5 x ULN.

    5) Allergies and Adverse Drug Reactions
    a) Known allergy to any of the study drugs or their excipients such as, prior severe Hypersensitivity Reaction (HSR) to agents containing Cremophor®EL; or allergies to Chinese hamster ovary cell proteins or other recombinant humanized antibodies.
    i) Prior Grade 1 or 2 hypersensitivity reaction to taxane therapies allowed
    provided drug administration was possible.

    6) Prohibited Treatments and/or Therapies
    a) Subjects must not continue or institute treatment with strong inhibitors of
    CYP3A4 from 72 hours prior to the initiation of study therapy until end of
    treatment with ixabepilone (e.g., ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, or voriconazole).
    b) Other concurrent anti-tumor chemotherapy, hormonal therapy, immunotherapy regimens or radiation therapy, standard or investigational.

    7) Other Exclusion Criteria
    a) Prisoners or subjects who are involuntarily incarcerated
    b) Subjects who are compulsorily detained for treatment of either a psychiatric or
    physical (eg, infectious disease) illness
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the Objective Response (OR). A subject will have an OR if their best overall response during the study is either a Complete Response (CR) or a Partial response (PR) according to the Response Evaluation Criteria in solid Tumours (RECIST) criteria. Tumor response will be assessed for all randomized subjects and will be evaluated using the RECIST criteria. Tumor assessments will be performed every 6 weeks for the first 12 months and every three months after that until disease progression.
    Safety information will be collected for all subjects enrolled in the study. Laboratory values, adverse events and other symptoms will be graded according to the NCI CTC Version 3.0.
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ixabepilone monotherapy versus Ixabepilone + Cetuximab combination therapy
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    The study will be completed once all subjects have progressed or 15 months after the Last Patient First Visit (LPFV), whichever comes first.
    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 months7
    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 months7
    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 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    Subjects experiencing toxicities at study completion will be followed until all toxicities (except alopecia and fatigue) have resolved to baseline (or ≤ CTCAE Grade 1), stabilized, or deemed irreversible
    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 Decision2008-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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