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    Summary
    EudraCT Number:2008-005843-40
    Sponsor's Protocol Code Number:PXD101-CLN-19
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-005843-40
    A.3Full title of the trial
    Estudio multicéntrico y abierto con Belinostat en pacientes con linfoma de células T periféricas (PTCL) reincidente o refractario.

    A Multicenter, Open-Label Trial of Belinostat in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
    A.3.2Name or abbreviated title of the trial where available
    Belinostat PTCL
    A.4.1Sponsor's protocol code numberPXD101-CLN-19
    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 SponsorTopotarget A/S
    B.1.3.4CountryDenmark
    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 No
    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 namePXD101
    D.3.2Product code PXD101
    D.3.4Pharmaceutical form 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 INNBelinostat
    D.3.9.1CAS number 414864-00-9
    D.3.9.2Current sponsor codePXD101
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.3.11.13.1Other medicinal product typeChemotherapy product
    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
    Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma

    Linfoma periférico de células T recurrente o resistente.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLT
    E.1.2Classification code 10034622
    E.1.2Term Peripheral T-cell lymphomas NEC
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the objective response rate in patients with peripheral T cell lymphoma who are treated with belinostat monotherapy.
    E.2.2Secondary objectives of the trial
    - safety of belinostat monotherapy
    - time to response
    - duration of response
    - time to progression (TTP)
    - progression-free survival (PFS)
    - one-year progression-free rate
    - one-year survival rate
    - overall survival (OS)
    Additional objectives are to assess:
    - population pharmacokinetics
    - patient and tumor characteristics that might distinguish responding from non-responding patients and factors associated with potential acquired drug resistance
    - patient baseline characteristics, including laboratory values, that might distinguish
    patients with differing safety profiles (correlative studies)
    - medical care utilization during treatment with belinostat monotherapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A histologically confirmed diagnosis of PTCL based on pathology review at the local institution, using the most recent edition of the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues as guidance leading to the diagnosis
    2. Pathology material must be available at the site for each patient before enrolment so that it can be sent to the Sponsor (or designee) for central pathology review.
    3. Patients must have relapsed or refractory disease after at least one prior systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.
    4. Patients must have at least one site of disease measurable in two dimensions by computed tomography (CT).
    5. Age ? 18 years.
    6. Laboratory status as follows:
    a. Absolute neutrophil count ? 1.0 x 109/L, platelets ? 50 x 109/L.
    b. Total bilirubin ?1.5 x upper normal limit, or ? 3 x upper normal limit if documented hepatic involvement with lymphoma, or ? 5 x upper normal limit if history of Gilbert?s Disease.
    c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ? 2.5 x upper normal limit (? 5 x upper normal limit if documented hepatic involvement with lymphoma).
    d. Serum potassium within normal range.
    e. Calculated creatinine clearance ? 45 mL/min/1.73 m2 based on Cockcroft and Gault?s method (Cockcroft 1976).
    f. PT or INR, and APTT ? 1.5 x upper limit of normal unless patient is receiving anticoagulants. If patient is on anticoagulation therapy, levels should be within therapeutic range.
    7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
    8. Estimated life expectancy greater than 3 months.
    9. Negative pregnancy test for women of childbearing potential.
    10. Signed informed consent form approved by the local Ethics Committee or Institutional Review Board.
    E.4Principal exclusion criteria
    1. Any use of anticancer therapies within 2 weeks prior to initiation of study treatment; in addition, patients should have recovered from prior treatment-related toxicities and meet laboratory and ECOG criteria for inclusion.
    2. Any use of investigational therapies within 3 weeks prior to initiation of study treatment.
    3. Major surgery within 2 weeks of study drug administration.
    4. Relapse within 100 days of autologous or allogeneic bone marrow transplant.
    5. Prior HDAC inhibitor therapy.
    6. Patients with a diagnosis of:
    ? Precursor T-cell lymphoma or leukemia
    ? Adult T-cell lymphoma/leukemia (ATLL)
    ? T-cell prolymphocytic leukemia
    ? T-cell large granular lymphocytic leukemia
    ? Primary cutaneous type anaplastic large cell lymphoma
    ? Mycosis fungoides/Sezary syndrome
    7. Co-existing active infection or any medical condition likely to interfere with trial procedures.
    8. Significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease), myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy (use of frequency adjusting medication for atrial fibrillation is allowed, if stable medication for at least last month prior to randomization and medication not listed as causing Torsade de Points, see Section 16.2, Appendix B), or evidence of acute ischemia on ECG.
    9. Baseline prolongation of QT/QTc interval, i.e., demonstration of a QTc interval > 450 msec; Long QT Syndrome; the required use of concomitant medication that may cause Torsade de Pointes (see Section 16.2 Appendix B for list of such medications).
    10. Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
    11. Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease free for greater than or equal to 2 years (except carcinoma in situ of breast, prostate cancer, or superficial bladder cancer).
    12. Symptomatic or untreated central nervous system (CNS) metastases. Patients with previously treated CNS metastases which are asymptomatic at baseline are permitted.
    13. Pregnant or breast-feeding women.
    14. Women of childbearing age and potential who are not willing to use effective contraception during the study and until 30 days after last dose of study drug. Male patients or male patients who have female partners of childbearing age and potential who are not willing to use effective contraception during the study and until 30 days after last dose of study drug. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
    15. Known infection with HIV, hepatitis B or hepatitis C.
    16. Patients that are not affiliated with social security (study centers in France only)
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is objective response rate (ORR), defined as complete response (CR) or partial response (PR) based on independent radiology review.
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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) 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Patients will be treated with belinostat 1000 mg/m2 30 minute iv infusion on days 1-5 every 3 weeks until there is disease progression or unmanageable treatment-related toxicities or patient wishes to stop treatment.
    All patients to be followed until progressive disease and furthermore patients are followed up til 2 years for survival.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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 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 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-06-02. Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 120
    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 Decision2009-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-27
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