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    Summary
    EudraCT Number:2007-005306-49
    Sponsor's Protocol Code Number:092-0
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-005306-49
    A.3Full title of the trial
    A Phase II Study Of Vorinostat (MK-0683) In Patients With Polycythaemia Vera And Essential Thrombocythaemia
    A.3.2Name or abbreviated title of the trial where available
    Vorinostat (MK0683)
    A.4.1Sponsor's protocol code number092-0
    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 SponsorHerlev Hospital
    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 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 nameVorinostat
    D.3.2Product code MK0683
    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.3.9.1CAS number 149647-78-9
    D.3.9.2Current sponsor codeMK-0683
    D.3.9.3Other descriptive namevorinostat
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100mg
    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
    The myeloproliferative disorders (MPDs) polycythaemia vera (PV) and essential thrombocythaemia (ET) are chronic haematological malignancies associated with increased risk of thrombosis, haemorrhage and leukaemic transformation. Recently an acquired mutation in JAK 2 has been described in >95% of patients with PV and 50% with ET.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this trial is to evaluate the safety and efficacy of Vorinostat in patients with advanced, refractory of resistant Polycythaemia Vera and Essential Thrombocythaemia and in those intolerant to other therapies.

    The main objectives are:

    1. To evaluate the safety and efficacy of a maximum of 6 months therapy with vorinostat in the treatment of patients with advanced, refractory or resistant polycythaemia vera (PV) and essential thrombocythaemia (ET) or in those intolerant of other therapies.
    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 parameteres (a decrease in the need of phlebotomy, leucocyte and platelet count).
    3. To investigate whether treatment with vorinostat influences the JAK2 mutation status as assessed by quantitative PCR.
    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
    Inclusion Criteria for PV
    1. 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).
    8.1b. Inclusion Criteria for 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).
    8.1c. Inclusion Criteria for both PV and 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)
    Complete Response: Pts <= 400 x 10 9/L and no disease-related symptoms and normal spleen size on imaging nad WBC count <= 10 x 10 9/L

    Partial Response: No CR and pts below 600 x 10 9/L or a decrease in patients > 50% of base line value
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 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 concerned5
    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 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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 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 2010-11-02. 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 state20
    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 Decision2009-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-14
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