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    Summary
    EudraCT Number:2007-005306-49
    Sponsor's Protocol Code Number:MK-0683-092
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-29
    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 ConcernedSweden - MPA
    A.2EudraCT number2007-005306-49
    A.3Full title of the trial
    A Phase II Study of Vorinostat in Patients with Polycythaemia Vera and Essential Thrombocythaemia
    A.4.1Sponsor's protocol code numberMK-0683-092
    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 SponsorDepartment of Haematology, Herlev Hospital, University of Copenhagen
    B.1.3.4CountryDenmark
    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 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 Zolinza
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZolinza (Vorinostat)
    D.3.2Product code MK-0683
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVorinostat
    D.3.9.1CAS number 14647-78-9
    D.3.9.2Current sponsor codeMK-0683
    D.3.9.3Other descriptive nameN-hydroxy-N'-phenyloctane diamide, suberoylanilide hydroxamic acid (SAHA)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    patients with polycythaemia vera and essential thrombocythaemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036057
    E.1.2Term Polycythaemia vera
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10015493
    E.1.2Term Essential thrombocythaemia
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (1) To evaluate efficacy of vorinostat in the treatment of patients with polycythaemia vera (PV) and essential thrombocythaemia (ET)
    (2) To evaluate if vorinostat as monotherapy of patients with PV and ET is followed by a decline in clonal myeloproliferation as assessed by conventional disease activity parameters (a decrease in the need of phlebotomy ( PV), leukocyte and platelet count)
    E.2.2Secondary objectives of the trial
    (1) To study changes in bone marrow morphology before and after treatment with vorinostat.
    (2) To investigate whether treatment with vorinostat influences the JAK2 mutation status as assessed by quantitative PCR.
    (3) To perform integrated gene expression (global and focused) profiling, epigenome profiling and proteome studies (serum-based) before and during treatment with vorinostat in order to describe in detail the various (heterogeneous) response patterns at the molecular level.
    (4) To study immune cells and function (dendritic cells, regulatory T-cells, NK-cells and specific T-cell responses) before and during treatment with vorinostat.
    (5) To study in vivo granulocyte, platelet and endothelial activation before and during treatment with vorinostat.
    (6) To evaluate the safety of vorinostat in the treatment of patients with polycythaemia vera (PV) and essential thrombocythaemia (ET).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PV:
    11. Male or female patient > 18 years of age and
    2. A confirmed diagnosis of PV (see appendix 1) and
    3. Biochemical evidence of active disease as defined by
    a) A need for phlebotomy within the last 3 months
    b) a leukocyte count > 10 x 109/L in the absence of infection or inflammation
    (normal CRP) and/or (PV/ET)
    c) a platelet count > 450 x 109/L in the absence of infection or inflammation
    (normal CRP) (PV/ET).

    ET:
    1. Male or female patient > 18 years of age and
    2. A confirmed diagnosis of high risk ET (see appendix 1) and
    3. Biochemical evidence of active disease as defined by
    a) a platelet count > 450 x 109/L in the absence of infection or inflammation
    (normal CRP).

    PV + ET:
    1. Newly diagnosed or previously treated patients in chronic phase or
    2. Advanced phase PV or ET as defined by blasts of > 1 x 109/L in the peripheral blood and/or white cell count > 30 x 109/L or
    3. Resistant or refractory PV or ET as defined by a haemoglobin < 10.5gm/dl with a platelet count > 600 x 109/L on current therapy or
    4. Cycling platelet counts on therapy or
    5. Intolerant to other therapies defined by patients with PV or ET who have side effects on current therapies preventing continuation (leg ulcers on hydroxycarbamide, unacceptable fatigue etc on interferon).
    E.4Principal exclusion criteria
    1. A platelet count > 1500 x 109/L (a need for cytoreduction in platelet count)
    2. Patients of childbearing potential without a negative pregnancy test prior to initiation of study drug.
    3. Women who are breast feeding
    4. Males and females not using contraceptives if sexually active.
    It is recommended that 2 reliable forms of contraception be used simultaneously unless abstinence is the chosen method of contraception. Non-pregnant, non-breast-feeding women may be enrolled if they are considered highly unlikely to conceive. Highly unlikely to conceive is defined as (a) surgically sterilized, or (b) postmenopausal, or (c) not heterosexually active for the duration of the study, or (d) heterosexually active and willing to use 2 birth control methods. The 2 birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy, used throughout the study starting with Visit 1. A woman who is ≥45 years of age and has not had menses for greater than 2 years will be considered postmenopausal.
    5. ECOG Performance Status Score ≥ 3
    6. Serum creatinine more than 2 x’s the ULN
    7. Total serum bilirubin more than 1.5 x’s the ULN
    8. Serum AST/ALT more than 3 x’s the ULN
    9. Interferon alpha within 1 week of day 1
    10. Hydroxycarbamide within 1 week of day 1
    11. Anagrelide within 1 week of day 1
    12. Valproic acid (as an anticonvulsant) within 28 days of day 1
    13. Any other investigational drug within 28 days of day 1
    14. Active HIV, HBV or HCV infection.
    15. Any serious concomitant disease or circumstances that could limit compliance with the study, including but not limited to the following: CTCAE grade 3-4 cardiac general & arrhythmia, or psychiatric or social conditions that may interfere with patient compliance.
    16. Any prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or other localized malignancy that has undergone potentially curative therapy with no evidence of that disease for five years, and who is deemed to be at low risk for recurrence by his/her treating physician.
    17. Patient has a known allergy or hypersensitivity to vorinostat capsules.
    E.5 End points
    E.5.1Primary end point(s)
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2008-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-15
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