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    The EU Clinical Trials Register currently displays   35335   clinical trials with a EudraCT protocol, of which   5785   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-002561-21
    Sponsor's Protocol Code Number:IFCT-1604
    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:2018-02-02
    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 number2017-002561-21
    A.3Full title of the trial
    Randomised Open Label Adaptive Phase III trial of addition of Belinostat to chemotherapy in patients with locally advanced potentially resectable Thymic Epithelial Tumors (TET)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of addition of belinostat to chemotherapy before surgery in patients with Thymic Epithelial Tumors (TET)
    A.3.2Name or abbreviated title of the trial where available
    BELCAP
    A.4.1Sponsor's protocol code numberIFCT-1604
    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 SponsorIFCT
    B.1.3.4CountryFrance
    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 supportOnxeo
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIFCT
    B.5.2Functional name of contact pointContact
    B.5.3 Address:
    B.5.3.1Street Address10 rue de la Grange-Batelière
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75009
    B.5.3.4CountryFrance
    B.5.6E-mailcontact@ifct.fr
    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 Beleodaq (in the USA)
    D.2.1.1.2Name of the Marketing Authorisation holderSpectrum Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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/3/13/1151
    D.3 Description of the IMP
    D.3.1Product nameBelinostat
    D.3.4Pharmaceutical form Powder 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 INNbelinostat
    D.3.9.1CAS number 414864-00-9
    D.3.9.3Other descriptive namePXD101
    D.3.9.4EV Substance CodeSUB121262
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Locally advanced potentially resectable Thymic Epithelial Tumors
    E.1.1.1Medical condition in easily understood language
    Locally advanced Thymus Tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061031
    E.1.2Term Thymoma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10026533
    E.1.2Term Malignant neoplasm of thymus
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of the induction treatment (after surgery and before any radiotherapy treatment) of adding belinostat to standard chemotherapy
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of the induction treatment (after surgery and before any radiotherapy treatment)
    To evaluate the risk of relapse (local and/or regional relapse and/or distant metastasis) during the follow up period
    To evaluate the long term overall survival
    To evaluate overall tolerance
    To evaluate quality of life
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic study : following pharmacokinetic parameters will be recorded both for belinostat and belinostat glucuronide: Cmax, Tmax, AUC (last, and inf), Half-life, Clearance (only for belinostat).
    ECG and QT/QTc analysis : A 12 lead ECG will be done for central review in the patients participating in the PK study in the BEL CAP arm (15 patients planned) and, as possible, in 15 patients in the control CAP arm to assess cardiac tolerance.
    E.3Principal inclusion criteria
    1. Histologically confirmed Thymoma (WHO classification A, AB, B1, B2, B3 ) or Thymic carcinoma.
    The diagnosis of TET will be confirmed by a central expert tumour board based on the review of the tumor biopsy realized at site of the initial diagnosis; no new tumour biopsy is required for TET diagnosis.
    2. Potentially resectable stage II-IVB (TNM IASLC-ITMIG 2014)
    3. Age ≥ 18 years
    4. WHO performance index of 0, 1
    5. Adequate organ function
    6. No previous treatment for TET
    7. Signed informed consent form

    E.4Principal exclusion criteria
    1. History of cancer except cancer dating from over three years ago and considered to be cured; appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma and stage I uterine cancer.
    2. History of previous radiotherapy to the mediastinum
    3. History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to any of the study drugs or their excipients
    4. Decompensated Myasthenia Gravis
    5. Significant cardiovascular disease of congestive heart failure Class III/IV to the NYHA Functional Classification, myocardial infarction within the past 6 months, unstable angina and unstable arrhythmia, left ventricular ejection fraction (LVEF) < 50% by either cardiac ultrasound or cardiac scintigraphy
    6. Baseline prolongation of QT/QTc interval > 480ms for 7 or more days; long QT syndrome;
    7. Concomitant use of strong UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir, ketoconazole, sorafenib) and concomitant medication that may cause Torsade de Pointes (refer to appendix I for list of drugs with known risk);
    8. Pregnant or breast-feeding women; Women of childbearing age and potential who are not willing to use effective contraception during the study treatment period and until 30 days after last dose of study drug. Male patients who have female partners of childbearing age and potential who are not willing to use effective contraception during the study treatment period and until 30 days after last dose of study drug.
    E.5 End points
    E.5.1Primary end point(s)
    % R0 Complete Resection in the two arms (experimental and control arms). R0 Complete Resection is defined as a complete resection of the primary tumor with no microscopic residual tumor (margins considered as microscopically negative: ≥ 1 mm) and complete macroscopic resection of pleural implants in stage IVA disease, assessed by a blinded pathologic central review.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery (6 weeks after the last treatment)
    E.5.2Secondary end point(s)
    % R0 Complete Resection assessed by the investigator’s site, with R0 defined as for the primary endpoint
    % surgical resection of primary tumor defined as % of patients arriving to surgical resection after induction treatment
    Pathological complete response (pCR) defined as % of patients with no microscopic residual tumor in the pathologic evaluation of the surgical specimen
    Complete surgical resection by operative technique and boarding approach defined as % of R0 achieved by boarding approach (sternotomy-mediastinotomy-thoracothomy-videothoracoscopy-clamshell)
    Objective Response Rate (ORR) defined as % of patients achieving a Response (complete response + partial response) after induction treatment according to RECIST 1.1 assessed by a Chest-CT Scan
    DFS (Disease-Free Survival) defined as the time from the date of randomisation to the date of documented relapse or death of any cause. DFS will be estimated using the Kaplan-Meier method and plotted as curves by treatment group.
    % Relapse defined as % of any relapse (local-regional-distant).
    Pattern of relapse defined as % of relapse by anatomic sites and % of local versus regional versus distant relapse.
    Post-operative morbidity and mortality defined as morbidity and mortality rate.
    Other cancers defined as cancers other than TET.
    To assess the impact of treatment toxicity until surgery by using QLQ-C30 LC13 and EQ-5D questionnaires.
    To assess long term quality of life by using QLQ-C30 LC13 and EQ-5D questionnaires during the follow-up period
    E.5.2.1Timepoint(s) of evaluation of this end point
    After surgery (6 weeks after the last treatment)
    After surgery (6 weeks after the last treatment)
    After surgery (6 weeks after the last treatment)
    After surgery (6 weeks after the last treatment)
    After surgery (6 weeks after the last treatment)
    4 weeks after the last treatment and before surgery
    3 years, 5 years and 10 year
    3 years, 5 years and 10 year
    3 years, 5 years and 10 year
    3 months
    3 months
    Until the end of the 10-year follow-up period
    14 days before inclusion, before each cycle of treatment (week 1, week 4 and week 7), and at end of treatment visit (week 121) and post-surgery visit (6 weeks after surgery +/- 1 week 24).
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Adaptative
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years13
    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 years13
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    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)
    None
    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 Decision2018-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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