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    Summary
    EudraCT Number:2007-000794-31
    Sponsor's Protocol Code Number:ET-B-027-06
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-16
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-000794-31
    A.3Full title of the trial
    Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) in
    Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-),
    HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers
    A.4.1Sponsor's protocol code numberET-B-027-06
    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 SponsorPharma Mar, S.A.
    B.1.3.4CountrySpain
    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 Yes
    D.2.1.1.1Trade name YONDELIS®
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar S.A.
    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 nameYONDELIS® (Trabectedin)
    D.3.2Product code ET-743
    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 INNtrabectedin
    D.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeET-743
    D.3.9.3Other descriptive nameEcteinascidin 743
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0. to 25
    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 YONDELIS®
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar S.A.
    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 nameYONDELIS® (Trabectedin)
    D.3.2Product code ET-743
    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 INNtrabectedin
    D.3.9.1CAS number 114899-77-3
    D.3.9.2Current sponsor codeET-743
    D.3.9.3Other descriptive nameEcteinascidin 743
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1. to 0
    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
    Progressive metastatic breast cancer previously treated in the following subpopulation of patients:
    Group A: Triple negative phenotype: Estrogen Receptor, Progesterone Receptor and
    HER-2 negative status (surrogate of basal-like type)
    Group B: HER-2 overexpressing tumors.
    Group C: Familial BRCA1 or BRCA2 mutation carriers
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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 determine the objective response rate by RECIST (Complete and Partial Response [CR + PR]) with trabectedin in patients with the following metastatic
    breast cancer subtypes:
    Group A: triple negative profile (ER-,PR-,HER-2-)
    Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+)
    Group C: familial BRCA1 or BRCA2 mutation carriers
    E.2.2Secondary objectives of the trial
    To assess in each group:
    • Duration of response
    • Progression-free survival
    • Exploratory evaluation of changes in tumor volume (three dimensional
    analysis) and changes in tumoral radiological density
    • Safety profile in this patient population
    • Exploratory, hypothesis-generating pharmacogenomic analyses to correlate
    molecular parameters in patient samples with clinical outcomes (objective
    response and PFS) within and across patient strata.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient´s written informed consent before any clinical trial-specific procedure.

    2. Woman 18 years-of-age or older.
    3. Histologically proven diagnosis of progressive metastatic breast cancer either in
    documented:

    • Group A: triple negative phenotype [Estrogen Receptor, Progesterone Receptor
    and HER-2 negative status (surrogate of basal-like type)]. Patients will
    be eligible if they had received prior therapy with an anthracycline and taxanes, including adjuvant or neoadjuvant therapy, but no more than three
    prior chemotherapy regimens for metastatic disease. NOTE: re-treatment with
    the same regimen or its components after a progression-free interval of 6 months
    or longer will be considered a second regimen. This arm is closed for recruitment.

    • Group B: HER-2 overexpressing breast cancer. Patients will be eligible if they
    have progressive metastatic disease following treatment with trastuzumab-based
    regimens or other HER-2 targeted therapy containing regimens, but no more than three prior regimens that contain HER-2 directed therapy and chemotherapy for metastatic disease are allowed. NOTE: re-treatment with the same regimen or its components after a progression-free interval of 6 months or longer will be considered as second regimen.

    • Group C: Familial BRCA1 or BRCA2 mutation carriers. Patients will be eligible if
    they have developed progressive metastatic disease after at least one prior
    chemotherapy regimen in the adjuvant or metastatic setting. There is no limit to the
    maximal number of prior therapies allowed

    4. Measurable disease as defined by the radiological (CT-scan and MRI) Response
    Evaluation Criteria in Solid Tumors (RECIST) Guidelines. If the only indicator lesion
    is in a previously irradiated area, the recurrence must be biopsy proven.

    5. Patients with bone metastases currently receiving biphosphonates for palliation
    will be eligible if other sites of measurable disease are present.

    6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

    7. Hematologic variables:
    • Hemoglobin ≥9 g/dL
    • Absolute neutrophil count (ANC) ≥1,500/μL, and
    • Platelet count ≥100,000/μL.

    8. Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 30 mL/min

    9. Creatinine phosphokinase (CPK) ≤ 2.5 ULN.

    10. Hepatic function variables
    • Total bilirubin ≤ ULN.
    • Total alkaline phosphatase ≤ 2.5 ULN, or if > 2.5 ULN consider alkaline
    phosphatase liver fraction or GGT or 5’ nucleotidase must be ≤ ULN, if the
    elevation could be osseous in origin.
    • AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine
    transaminase [SGPT]) must be ≤2.5 x ULN.

    11. Albumin ≥ 25 g/l.

    12. Complete recovered from the acute toxicity of any prior treatment. The presence
    of alopecia or NCI-CTC grade 1 symptomatic peripheral neuropathy is allowed.

    13. Patients may have CNS metastases if stable (no evidence of progression) for at
    least 3 months after local therapy.
    E.4Principal exclusion criteria
    1. Prior exposure to trabectedin.

    2. Known hypersensitivity to any of the components of the trabectedin i.v.
    formulation or dexamethasone.

    3. More than three prior chemotherapy regimens for metastatic disease for group A
    and B. NOTE:re-treatment with the same regimen or its components after a
    progression-free interval of 6 months or more is considered a second regimen.

    4. Pregnant or lactating women or any women of childbearing potential who is not
    employing adequate contraception. Acceptable methods of contraception include;
    IUD, and double barrier (condom with a contraceptive sponge or contraceptive
    suppository). Use of hormonal contraception is not acceptable during this clinical
    trial.

    5. Completion of prior therapy: less than 2 weeks from radiation therapy (radiated
    lesions may not serve as measurable disease) or last dose of hormonal therapy, less
    than 3 weeks from prior chemotherapy or biological therapy (all acute toxicities must
    be adequately recovered as per inclusion criteria # 12), less than 4 weeks with any
    investigational agent.

    6. History of another neoplastic disease (except basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer.Group C patients can be enrolled with less than 5 years remission from another neoplastic disease; however, appropriate biopsy confirming current metastasic breast cancer is mandatory.

    7. Patients with known leptomeningeal disease.

    8. Other serious illnesses, such as:
    • Congestive heart failure or angina pectoris; myocardial infarction within 1 year
    before enrollment; uncontrolled arterial hypertension or arrhythmias
    • Psychiatric disorder that prevents compliance with protocol
    • Active viral hepatitis; or chronic liver disease
    • Active infection
    • Any other unstable medical conditions

    9. Patients with a life expectancy < 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed objective tumor response (CR or PR) rate (RECIST) in each group.
    Each patient will be assigned one of the following categories:
    Complete response (CR)
    Partial response (PR)
    Stable disease (SD)
    Progressive disease (PD)

    Reasons for non-evaluability will be subdivided into the following categories:
    1) ‘early toxicity’ (as reason for withdrawal without on-/end-oftreatment
    tumor assessment available)
    2) ‘never treated’ (no on-/end-of-treatment tumor assessment available)
    3) ‘other’ (e.g., no baseline tumor assessment, technical
    reasons, absence of on-/end-of-treatment tumor assessment for other reasons than ‘death’, ‘early toxicity’ or ‘never treated’, consent withdrawal before evaluation,)

    To be assigned a status of PR or CR, changes in tumor measurements must be
    confirmed by repeated assessments that should be performed no less than 4 weeks after the criteria for response are first met.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 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 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.8.4.1Number 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 EEA14
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 predefined date of study termination (clinical cut-off) is set 30 days after the last visit of the last evaluable patient.
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 149
    F.4.2.2In the whole clinical trial 321
    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 Decision2008-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-11
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