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    Summary
    EudraCT Number:2006-003554-15
    Sponsor's Protocol Code Number:18031977
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-28
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-003554-15
    A.3Full title of the trial
    The histone deacetylase inhibitor (HDAC) valproic acid as second line treatment for hormone refractory metastatic prostate cancer. A phase II. study.
    A.3.2Name or abbreviated title of the trial where available
    HDAC-VA
    A.4.1Sponsor's protocol code number18031977
    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 SponsorNational Cancer Institute
    B.1.3.4CountrySlovakia
    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 Everiden
    D.2.1.1.2Name of the Marketing Authorisation holderZentiva
    D.2.1.2Country which granted the Marketing AuthorisationSlovakia
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 Information not present in EudraCT
    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
    hormone refractory metastatic prostate cancer
    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
    To determine the efficacy (as measured by tumor response) of valproic acid given orally to patients with hormone refractory metastatic prostate cancer after first line chemotherapy.
    E.2.2Secondary objectives of the trial
    To describe the time to progression and toxic effects of valproic acid in patients with hormone refractory metastatic prostate cancer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. signed written informed consent
    2. men aged 18 years or older
    3. histologically proven metastatic hormone refractory prostatic adenocarcinoma, with progression after standard 1st line chemotherapy (only docetaxel+prednisone). The progression is defined: progression according RECIST criteria or evidence of PSA progression. Minimum evidence of progression is a 25% increase over a reference value of PSA (20ng/mL), provided that the increase is > 5 ng/mL. The first increase in PSA should occur at a minimum of one week from the reference value. This increase should then be confirmed by a second increase in PSA at least 1 week later (Bubley, 1999).
    4. patients with measurable or non-measurable disease as defined in the RECIST criteria: At least one site of disease must be unidimensionally measurable as follows:
    X-ray, physical exam > 20 mm } N.B. Most hospitals have spiral CT scanning
    Spiral CT scan > 10 mm } equipment – check with your radiology department.
    Non-spiral CT scan > 20 mm }
    All radiology studies must be performed within 28 days prior to registration
    5. ECOG PS 0 – 1 at study entry
    6. at least 4 weeks must have elapsed since the last surgery, radiotherapy and/or chemotherapy before study entry
    7. complete recovery from prior surgery, and/or reduction of all adverse events to grade 1 from previous systemic therapy or radiotherapy
    8. no concurent treatment with experimental drugs was allowed.
    9. no concurrent chemotherapy. Corticosteroids and bisphophonates are permitted if they were admistered more than 2 months before study entry in the same dose and route of application.
    10. patients with surgical castration or patients without surgical castration must have a serum testosterone level less than 50ng/ml before study entry and to continue on LHRH agonist therapy
    11. adequate renal function defined as creatinine clearance > 60ml/min
    12. adequate liver function defined by normal total bilirubin level and ALT, AST < 2,0 ULN
    13. adequate hematologic function defined by ANC > 1500/mm3, platelet count > 100 000/mm3 and hemoglobin level > 9g/dl.
    14. normal blood coagulation tests: INR, fibrinogen, PTT, bleeding time
    15. serum albumin level > 34g/l
    16. life expectancy more than 3 months
    17. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
    E.4Principal exclusion criteria
    1. inability to absorb medication e.g. malabsorption syndrome
    2. hepatic porphyria
    3. acute or chronic hepatitis (positivity HbsAg, antiHCV and/or LFT`s see also inclusion criteria)
    4. hypersensitivity to valproic acid
    5. personal or familial history of severe drug induced hepatitis
    6. grade 3-4 infection without neutropenia
    7. known CNS metastasis
    8. Any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years.
    9. Serious concomitant systemic disorders or diseases incompatible with the study (at the discretion of investigator )
    10. systemic lupus erythematosis
    E.5 End points
    E.5.1Primary end point(s)
    Response rate (according to Bubleys criteria)
    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 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 No
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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 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
    6 months after the last administration of valproic acid (Everiden) in the trial
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 No
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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 Decision2006-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-02-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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