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    Summary
    EudraCT Number:2014-002446-47
    Sponsor's Protocol Code Number:1320-BTG
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-13
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-002446-47
    A.3Full title of the trial
    Trabectedin for recurrent grade II or III meningioma: a randomized phase II study of the EORTC Brain Tumor Group.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trabectedin for recurrent grade II or III meningioma: a randomized phase II study of the EORTC Brain Tumor Group.
    A.4.1Sponsor's protocol code number1320-BTG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02234050
    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 SponsorEuropean Organization for Research and Treatment of Cancer (EORTC)
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEORTC
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportPharma Mar, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organization for Research and Treatment of Cancer (EORTC)
    B.5.2Functional name of contact pointClinical operations department
    B.5.3 Address:
    B.5.3.1Street AddressAvenue E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number003227741015/
    B.5.5Fax number003227741030/
    B.5.6E-mailregulatory@eortc.be
    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 1 mg powder for concentrate for solution for infusion
    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.3.4Pharmaceutical 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 INNTRABECTEDIN
    D.3.9.1CAS number 114899-77-3
    D.3.9.4EV Substance CodeSUB20756
    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
    Recurrent high-grade meningioma
    E.1.1.1Medical condition in easily understood language
    Recurrent high-grade meningioma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10027191
    E.1.2Term Meningioma
    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
    The aim of this randomized phase II study is to collect data on activity, safety and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.
    E.2.2Secondary objectives of the trial
    The aim of this randomized phase II study is to collect data on activity, safety and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma and to investigate whether trabectedin demonstrates sufficient antitumor activity against recurrent grade II or III to justify further investigation in phase III or as adjuvant therapy for newly diagnosed disease after resection and radiotherapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ♦Age 18 or older.
    ♦Histological diagnosis of WHO grade II (chordoid meningioma, clear
    cell meningioma, atypical meningioma) or WHO grade III (papillary
    meningioma, rhabdoid meningioma, anaplastic/malignant meningioma)
    according to WHO 2007 classification.
    ♦Radiologically documented progression of any existing tumor (growth
    > 25% in the last year) or appearance of new lesions (including intraand
    extracranial manifestations).
    ♦Measurable disease (10 x10 mm) on cranial MRI or CT
    thorax/abdomen no more than 2 weeks prior to randomization
    ♦WHO performance status 0-2
    ♦Adequate liver, renal and hematological function within 2 weeks prior
    to randomization, defined as:
    ♦Neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL or hemoglobin ≥
    5.6 mmol/L, platelets ≥ 100 x 109/L
    ♦Total Bilirubin ≤ ULN, SGPT/ALT and SGOT/AST ≤ 2.5 x ULN
    ♦Alkaline phosphatase ≤ 2.5 x ULN; if alkaline phosphatase > 2.5 ULN,
    hepatic isoenzymes 5-nucleotidase or gamma glutyamyltransferase
    (GGT) must be within the normal range
    ♦Albumin ≥ 30 g/L
    ♦Serum creatinine ≤ 1.5 x ULN
    ♦Creatinine clearance > 30 ml/min as calculated by Cockcroft and
    Gault formula (see Appendix E)
    ♦Creatine phosphokinase (CPK) ≤ 2.5 x ULN
    ♦Normal cardiac function (LVEF assessed by MUGA or ECHO within
    normal range of the institution), normal 12 lead ECG (without clinically
    significant abnormalities). The following unstable cardiac conditions are
    not allowed:
    ♦Congestive heart failure
    ♦Angina pectoris
    ♦Myocardial infarction within 1 year before
    registration/randomization
    ♦Uncontrolled arterial hypertension defined as blood pressure ≥
    150/100 mm Hg despite optimal medical therapy
    ♦Arrhythmias clinically significant
    ♦Life expectancy of at least 9 weeks
    Women of child bearing potential (WOCBP) must have a negative serum
    (or urine) pregnancy test within 72 hours prior randomization (and
    again within 72 hours prior to to the first dose of study treatment).
    Patients of childbearing / reproductive potential should use adequate
    birth control measures, as defined below, during the study treatment
    period and for at least 3 months after the last study treatment. Men who
    are fertile must use effective contraception during treatment with
    trabectedin and for 5 months thereafter. Methods that can achieve a
    failure rate of less than 1% per year when used consistently and
    correctly are considered as highly effective birth control methods. Such
    methods include:
    ♦ combined (estrogen and progestogen containing) hormonal
    contraception associated with inhibition of ovulation:
    ♦ oral
    ♦ intravaginal
    ♦ transdermal
    ♦ progestogen-only hormonal contraception associated with inhibition
    of ovulation:
    ♦ oral
    ♦ injectable
    ♦ implantable
    ♦ intrauterine device (IUD)
    ♦ intrauterine hormone-releasing system ( IUS)
    ♦ bilateral tubal occlusion
    ♦ vasectomised partner
    ♦ sexual abstinence
    ♦ Acceptable birth control methods that result in a failure rate of more
    than 1% per year include:
    ♦ progestogen-only oral hormonal contraception, where inhibition of
    ovulation is not the primary mode of action
    ♦ male or female condom with or without spermicide
    ♦ cap, diaphragm or sponge with spermicide
    ♦Female subjects who are breast feeding should discontinue nursing
    prior to the first dose of study treatment and until 3 months after the
    last study treatment.
    ♦Absence of any psychological, familial, sociological or geographical
    condition potentially hampering compliance with the study protocol and
    follow-up schedule; those conditions should be discussed with the
    patient before registration in the trial
    ♦Before patient randomization, written informed consent must be given
    according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    ♦More option for local therapy (resection or radiotherapy) after maximal
    feasible surgery and radiotherapy.
    ♦Prior systemic anti-neoplastic therapy for meningioma (patient may
    have received prior radionuclide therapy).
    ♦History of any other invasive malignancy within the last 5 years
    (except adequately treated non-melanoma skin cancer, clinicaly
    localized and very low risk prostate cancer, and adequately treated
    cervical intraepithelial neoplasia).
    ♦Serious illness or medical conditions, specifically: active infectious
    process; chronic active liver disease, including chronic hepatitis B, C or
    cirrhosis.
    ♦ Concomitant use of any other investigational agent, phenytoin, or
    vaccination to yellow fever.
    ♦ Known hypersensitivity or contraindication to trabectedin or any of
    the ingredients of the trabectedin solution for infusion
    ♦ Known MRI or CT, including contrast media, contraindications.
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression Free Survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. PFS will be measured from the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first. Patients without evidence of progression will be censored at the last follow-up visit date. If a patient received a second anti-tumoral therapy without prior documentation of disease progression, the patient will be censored at the date of starting new anti-tumoral therapy.
    E.5.2Secondary end point(s)
    1. Progression Free Survival at 6 months (PFS-6), median PFS (mPFS)
    2. Best overall response (BOR). Objective response (CR/PR), rate and median duration. Complete response (CR), rate and median duration.
    3. Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)
    4. Safety (CTCAE v.4.0)
    5. Health-related Quality of life (HRQol)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.PFS-6 will be measured from the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first.
    2.BOR will be measured from date of randomization until disease progression.CR/PR will be measured similar to PFS but starting from the time measurement criteria for CR/PR are first met.
    3.From date of randomiwation up t the date of death (any cause).For patients still alive or lost to f/up at the time of analysis, survival will be censored at lastf/upvisitdate.
    4.From the randomization until 30 days after last protocol treatment administration; or until the start of a new antitumor therapy.
    5.At every scheduled visit, 4 weeks prior to randomization.
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health-related Quality of life (HRQol)
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    France
    Germany
    Italy
    Netherlands
    Spain
    Switzerland
    United Kingdom
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after last treatment administration to the last patient on protocol.
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol.
    3. The database has been fully cleaned and frozen for this analysis.
    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.1.1.1In 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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 81
    F.4.2.2In the whole clinical trial 86
    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)
    Treatment should be given as per the protocol until disease progression, unacceptable toxicity or patient refusal. After progression, treatment is at the discretion of the treating physician.
    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 Decision2015-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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