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    Summary
    EudraCT Number:2010-022968-13
    Sponsor's Protocol Code Number:ET-B-031-10
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-022968-13
    A.3Full title of the trial
    Multicenter, Open-Label, Phase II Study of Trabectedin (Yondelis®) in Patients with Hormonal Receptors Positive, HER2 Negative, Advanced Breast Carcinoma, Overexpressing or Underexpressing Xeroderma Pigmentosum G Gene (XPG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the medicinal product Trabectedin in Patients with Advanced
    Breast Carcinoma.
    A.4.1Sponsor's protocol code numberET-B-031-10
    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 SponsorPharma Mar, S.A. Sociedad Unipersonal
    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 supportPharma Mar, S.A. Sociedad Unipersonal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaMar S.A. Sociedad Unipersonal
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAvda de los Reyes, 1. Polígono Industrial "La Mina"
    B.5.3.2Town/ cityColmenar Viejo
    B.5.3.3Post code28770
    B.5.3.4CountrySpain
    B.5.4Telephone number0034 91 8466000
    B.5.5Fax number0034 91 8466001
    B.5.6E-mailclinicaltrials@pharmamar.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 Yondelis 0.25 mg powder for concentrate for solution for infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar, S.A. Sociedad Unipersonal
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/01/039
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for 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 INNtrabectedine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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) 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 Yondelis 1 mg powder for concentrate for solution for infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderPharma Mar, S.A. Sociedad Unipersonal
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/01/039
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for 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 INNtrabectedine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Advanced Breast Carcinoma
    E.1.1.1Medical condition in easily understood language
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10006204
    E.1.2Term Breast carcinoma
    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
    To evaluate the efficacy in terms of progression-free survival rate at 4 months (PFS4) of trabectedin in patients with advanced or MBC, hormonal receptors positive, HER2 negative, positive or negative for XPG overexpression, who have already received at least two lines of chemotherapy for advanced disease (including anthracyclines and taxanes).
    E.2.2Secondary objectives of the trial
    To compare progression-free survival (PFS), objective response rate (ORR) and duration of response (DR), as defined by the Response Evaluation Criteria in Solid Tumors (RECIST, v.1.1) in patients positive or negative for XPG overexpression.
    To compare overall survival in patients positive or negative for XPG overexpression.
    Safety profile.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years.
    2. Voluntary written informed consent, obtained from the patient before the beginning of any specific study procedures.
    3. Histologically proven diagnosis of advanced or MBC.
    4. Patients must be HER2 negative and hormone receptors (estrogen receptor and/or progesterone receptor) positive.
    5. Failure to at least two but no more than five chemotherapy lines in the advanced setting.
    6. Previous treatment with anthracyclines or taxanes.
    7. XPG RNA expression determined from patient's tumor specimen (paraffinembedded tissue).
    8. Measurable disease as defined by the RECIST v.1.1. If the only tumor lesion is situated in a previously irradiated area, or in an area subjected to other locoregional therapy, progression in the lesion must be demonstrated.
    9. Patients with bone metastases currently receiving bisphosphonates for palliation will be eligible if other sites of measurable disease are present.
    10. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (see Appendix 1).
    11. Adequate bone marrow, liver and kidney function:
    a. Hemoglobin ≥ 9g/dl.
    b. Neutrophil count ≥ 1.5×109/l.
    c. Platelet count ≥ 100×109/l
    d. Serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance ≥ 30 ml/min.
    e. Albumin ≥2.5g/dl.
    f. Total serum bilirubin ≤ upper limit of normal (ULN), except in case of Gilbert's syndrome.
    g. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN.
    h. Total alkaline phosphatase (AP) ≤2.5×ULN; if the value is >2.5×ULN, evaluate the hepatic AP isoenzyme and/or gamma-glutamyltransferase (GGT) and/or 5'nucleotidase, which values must be within the ULN (this indicates that the elevation of AP was of bone origin).
    i. Creatine phosphokinase (CPK) ≤2.5×ULN.
    12. Life expectancy ≥3 months.
    13. Complete recovery to grade ≤ 1 from any toxicity due to previous therapy (except for alopecia and grade 2 neuropathy).
    14. Women of child-bearing potential must have a negative pregnancy test prior to the treatment initiation and use a medically approved method of contraception during treatment with the trial medication and for three months after the last
    administration of the study drug. Fertile men must use a medically approved method of contraception during the treatment with the trial medication and for five months after the last administration of the study drug.
    E.4Principal exclusion criteria
    Patients fulfilling any of the following criteria will not be included into
    the trial:
    1. Prior exposure to trabectedin.
    2.Treatment with chemotherapy or with biological agents in the two
    weeks prior to the first dose of the clinical trial drug (six weeks for
    nitrosoureas or mitomycin C) provided that patients have recovered to
    grade ≤ 1 from any toxicity due to prior therapy (except alopecia and
    grade 2 neuropathy)(see inclusion criterion 13).
    3. Participation in another clinical trial, or concomitant treatment with
    any investigational drug, in the four weeks prior to enrollment in the
    clinical trial.
    4. Concomitant administration of any other antineoplastic therapy.
    5. Contraindications to corticosteroid use.
    6. History of another neoplastic disease (except for basal cell carcinoma of the skin or properly treated carcinoma in situ of the uterine cervix) unless in remission for five years or longer.
    7. Presence of cerebral and/or leptomeningeal metastasis, even if they
    are being treated.
    8. Other serious and/or relevant diseases or clinical situations that, in
    opinion of the Investigator, are incompatible with the protocol (any of the following):
    a. History of cardiac disease, such as myocardial infarction, in the year
    prior to enrollment in the clinical trial; symptomatic/uncontrolled angina
    pectoris; congestive heart failure or uncontrolled cardiac ischemia; any
    type of uncontrolled arrhythmia or abnormal left ventricular ejection
    fraction, or uncontrolled arterial hypertension (according to the
    standards of the World Health Organization [WHO]).
    b. History of significant psychiatric disease.
    c. Active infection requiring antibiotic, antifungal or antiviral treatment
    that, in the opinion of the Investigator, could compromise the patient's capacity to tolerate the therapy.
    d. Active liver (hepatitis B or C) or renal disease.
    e. Major surgery in the two weeks prior to entering the clinical trial, or
    any other concomitant pathology that could jeopardize the patient's safety or commitment to complete the clinical trial.
    9. Pregnant or breastfeeding women (negative pregnancy test in the
    three days prior to treatment administration required).
    10. Inability or refusal to comply with the protocol or with the clinical
    trial procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the progression-free survival rate at 16 weeks (PFS4), defined as the percentage of patients remaining alive and progression-free at Week 16 after the first treatment dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Main analysis of PFS4 will be done when 50 evaluable patients are
    recruited in each XPG stratum. Futility analyses are planned once 20 evaluable patients are enrolled in each XPG stratum. Each analysis will be performed using the O'Brien Fleming boundary, after evaluable patients have had a tumor assessment at Week 16 or PD or died due to disease progression or discontinued treatment due to unmanageable toxicity, whichever occurs first. The minimum follow-up to do this analysis will be 16 weeks after the last patient recruited has received the first trabectedin infusion.
    The patient’s survival will be assessed every three months.
    E.5.2Secondary end point(s)
    To compare progression-free survival (PFS), overall response
    rate (ORR) and duration of response (DR), as defined by the
    Response Evaluation Criteria in Solid Tumors (RECIST, v.1.1)
    in patients positive or negative for XPG overexpression.
    To compare overall survival in patients positive or negative for
    XPG overexpression.
    Safety profile.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints (if applicable) would be assessed at the same time than primary endpoint analysis.
    The planned study termination (clinical cut-off) is:
    Four months after the first infusion of the last evaluable patient
    recruited if the trial is stopped at the first stage.
    Three months after the last infusion administered if the study proceeds into the second stage.
    The patient’s survival will be assessed every three months.
    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 Yes
    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) 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 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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 No
    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 planned study termination (clinical cutoff) will be:
    -Four months after the first infusion of the last evaluable patient recruited if the trial is stopped at the first stage.
    -Three months after the last infusion administered if the study proceeds into the second stage.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.2Preterm 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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Not applicable
    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 Decision2011-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-25
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