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    Summary
    EudraCT Number:2009-011041-12
    Sponsor's Protocol Code Number:ET-A-018-09
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-06-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-011041-12
    A.3Full title of the trial
    Étude multicentrique de phase Ib-II en escalade de dose de la trabectédine (Yondelis®) en association avec l’oxaliplatine chez des patientes atteintes d’un cancer de l’ovaire avancé prétraité.
    A.4.1Sponsor's protocol code numberET-A-018-09
    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 0.25 mg and 1.0 mg
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/03/171
    D.3 Description of the IMP
    D.3.1Product nameYondelis
    D.3.2Product code ET-743
    D.3.4Pharmaceutical form Powder for concentrate 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
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05 mg/ml
    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.2.5The 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 nameOxaliplatin
    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 INNOxaliplatin
    D.3.9.1CAS number 63121-00-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mg/ml
    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
    Pretreated Advanced Ovarian Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian 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
    Phase Ib

    Phase Ib stage: To determine the recommended dose (RD) of the combination of trabectedin and oxaliplatin in patients with advanced ovarian cancer.

    Phase II

    Phase II stage: To determine the antitumor activity of the combination of trabectedin and oxaliplatin, administered at the RD established in the phase Ib stage, in patients with advanced ovarian cancer.
    E.2.2Secondary objectives of the trial
    Phase Ib only

    To determine the efficacy of the combination of trabectedin and oxaliplatin.

    Phase Ib/II

    To determine the safety profile of this trabectedin-oxaliplatin regimen in this population.

    To determine the pharmacokinetic (PK) profile for each drug when administered in combination.

    To determine the pharmacogenomic (PGx) profile of tumor samples from the patients participating in this trial. Hypothesis-generating exploratory PGx analyses will be conducted to correlate the molecular parameters found in the tumor samples of the patients with the clinical results achieved with the trabectedin-oxaliplatin regimen.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENOMIC STUDIES USING TUMOR TISSUE OF PATIENTS INCLUDED IN THE CLINICAL STUDY ET-A-0018-09

    1. Determine the gene and protein expression profiles of tumor tissue of the patients included in the clinical study ET-A-018-09.
    2. Determine the genotype of the SNP Asp1104His of XPG and other SNPs related to the mechanism of action (MOA) of trabectedin.
    3. Correlate the gene and protein expression profiles and the SNP genotype with the clinical outcome of the patients treated with the combination trabectedin + oxaliplatin and the evolution of the disease.
    E.3Principal inclusion criteria
    1. Age ≥ 18 years.
    2. Eastern Cooperative Oncology group (ECOG) performance status (PS) ≤ 2.
    3. Patients with histologically proven relapsed ovarian carcinoma.
    4. Prior treatment with at least one line of platinum compounds and taxanes, with no more than two prior lines of platinum-based therapy, and no more than three prior lines of chemotherapy.
    5. Recovered from toxicity associated with prior treatments to National Cancer Institute Common Terminology Criteria version 3.0 (NCI-CTCAE) grade 0/1 (except for alopecia).
    6. Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (for phase II only).
    7. Acceptable hematological and biochemical function, including: absolute neutrophil count (ANC) ≥ 1.5 x 109/l, platelet count > 100 x 109/l, creatinine < the upper limit of normal (ULN), total bilirubin ≤ ULN, transaminases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)] ≤ 2.5 x ULN. Total alkaline phosphatase (AP) ≤ 2.5 x ULN; if the value is > 2.5 x ULN, evaluate the hepatic AP isoenzyme and/or gamma-glutamyltransferase (GGT) and/or 5’ nucleotidase, whose values must be within the ULN.
    8. 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 the trial and for four months after the last administration of study drug.
    9. Voluntarily signed and dated written informed consent prior to any specific study procedures.
    E.4Principal exclusion criteria
    1. Pregnant or lactating women.
    2. Prior exposure to trabectedin or oxaliplatin.
    3. Known allergy to any component of trabectedin, oxaliplatin or dexamethasone.
    4. Contraindications for the use of corticosteroids.
    5. Clinical symptoms of brain metastasis.
    6. History of another neoplastic disease (except basal cell carcinoma or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years (for phase II only).
    7. Symptomatic sensitive neuropathy grade > 1 as per NCI-CTCAE, version 3.0.
    8. Less than three weeks between treatment with radiotherapy, hormone therapy, biological therapy, investigational product or chemotherapy (six weeks for nitrosoureas or mitomycin-C) and inclusion.
    9. Other serious and/or relevant diseases that, in opinion of the Investigator, are incompatible with the protocol (including 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, or arrhythmia, abnormal left ventricular ejection fraction, or uncontrolled arterial hypertension.
    b. Active infection.
    c. Active or chronic liver or renal disease.
    d. Major surgery in the two weeks prior to entering the clinical trial.
    10. Patients unable to comply with the study protocol owing to psychological, social or geographical reasons.
    11. Participation in another clinical trial or concomitant treatment with any investigational product within 21 days prior to inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib stage: The determination of the RD will be evaluated in patients who are treated and followed for at least one cycle of the combination, or who experience a DLT during the first cycle. The MTD will be the level at which ≥ 2/3 or ≥ 2/6 evaluable patients have a DLT in Cycle 1. The RD will be the dose level immediately below the MTD. A minimum of ten evaluable patients will be treated at the RD.

    Phase II stage: Overall response rate (ORR), defined as the percentage of patients with confirmed objective response (OR), either complete (CR) or partial (PR) response according to the RECIST criteria.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    dose finding of combination (first administration to humans of combination)
    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 No
    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 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 concerned2
    E.8.5The trial involves multiple Member States No
    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
    Six months after the last treatment visit of the last evaluable patient included in the study or 12 months after the last patient is included, whichever occurs 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 months4
    E.8.9.1In the Member State concerned 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 state64
    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 Decision2009-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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