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    Summary
    EudraCT Number:2005-000949-11
    Sponsor's Protocol Code Number:014
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-12-30
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2005-000949-11
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral
    Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral
    Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    Phase III
    A.4.1Sponsor's protocol code number014
    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 SponsorMerck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Regional Bussines Support Center GmbH
    B.5.2Functional name of contact pointMSD Regional Bussines Support Cente
    B.5.3 Address:
    B.5.3.1Street AddressRichard-Reitzner-Alle 1
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code85540
    B.5.3.4CountryGermany
    B.5.4Telephone number89 4566 55220
    B.5.5Fax number89 4566 55222
    B.5.6E-mailottfried_zierenberg@msd.de
    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 MK-0683
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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.3.9.2Current sponsor codeMK-0683
    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) 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 Yes
    D.3.11.13.1Other medicinal product typecytotoxic oncology medication
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Malignant Pleural Mesothelioma previously treated with systemic chemotherapy.
    E.1.1.1Medical condition in easily understood language
    Advanced Malignant Pleural Mesothelioma previously treated with systemic chemotherapy.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10035605
    E.1.2Term Pleural mesothelioma malignant advanced
    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 compare the overall survival associated with vorinostat plus best supportive care versus that associated with placebo plus best supportive care for the treatment of patients with advanced malignant pleural mesothelioma who have failed at least one prior chemotherapy regimen, and to determine the overall safety and toxicity of vorinostat in this population.
    E.2.2Secondary objectives of the trial
    E.2.2 Secondary objectives:
    To compare between vorinostat plus best supportive care versus placebo plus best supportive care for the treatment of patients with advanced malignant mesothelioma who have failed at least one prior chemotherapy regimen with respect to:
    a. Progression-free-survival
    b. Overall objective response rate
    c. Dyspnea score of lung cancer symptom scale modified for mesothelioma (LCSS-Meso) at Week 12; and
    d. Percent change from baseline in forced vital capacity (FVC) at Week 12.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a.Patient must have a histologically and/or cytologically confirmed diagnosis of epithelial, sarcomatoid, or mixed histology malignant pleural mesothelioma and: In countries where pemetrexed is an approved mesothelioma treatment, the patient's mesothelioma has progressed or relapsed following treatment with at least one prior chemotherapy regimen with pemetrexed and either cisplatin or carboplatin. OR I
    n countries where pemetrexed is not approved for mesothelioma, the patient's mesothelioma has progressed or relapsed following treatment with at least one prior chemotherapy regimen. OR In the opinion of the investigator, pemetrexed is not the preferred therapy for the patient, and the patient's mesothelioma has progressed or relapsed following treatment with at least one prior chemotherapy regimen.
    NOTE: If patient was not previously treated with pemetrexed, please document reason in the patients study record, i.e.: not approved, contraindicated for patient, reimbursement not available, or other reason to be specified.
    b.Patient must have received no more than 2 prior systemic therapy regimens.
    c.Patient must have an area of pleural rind thickness measured by meso-modified RECIST [10] that is at least 1.0 cm in line-length on a spiral computerized tomography (CT) scan.
    e.Patient has a Karnofsky performance scale status of ?70 (see Appendix 1).
    j.Patient must have completed previous chemotherapy or radiotherapy at least 4 weeks before drug administration (6 weeks for nitrosoureas or mitomycin C) and have recovered from any treatment-related toxicities (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade ?1 or recovered to pre-treatment levels).

    a. Any patient who was previously enrolled on MK-0683 P014 who did not experience progression of malignant pleural mesothelioma while
    receiving treatment with vorinostat will have the option to enroll in a
    Treatment Extension Phase of the study. This option will be available if
    the investigator believes that the patient may benefit from treatment with open label vorinostat to treat their malignant pleural mesothelioma.
    Investigators will have up to three months from the time that they are
    notified of the final study results to enroll patients into the Treatment
    Extension Phase.
    The following patients may enroll in the Treatment Extension Phase
     patients who are receiving treatment with vorinostat and have not
    experienced progression of mesothelioma
     patients who were randomized to the placebo arm and meet the
    eligibility criteria for the Treatment Extension Phase outlined in
    Section I. D. 3
     for those patients assigned to vorinostat who have discontinued study therapy for reasons other than progression of mesothelioma, it is left to the investigator's discretion as to whether the potential benefit
    outweighs potential risks associated with using vorinostat
    E.4Principal exclusion criteria
    a. Patient had prior treatment with an HDAC inhibitor (e.g., Depsipeptide, MS 275, LAQ-824, PXD-101, and valproic acid). Patients who have received such agents for other indications, e.g. epilepsy, may enroll on vorinostat trials after a 30-day washout period.
    b. Patient has an active infection for which the patient received intravenous antibiotic, antiviral, or antifungal medications within 2 weeks prior to the start of study drug.
    c. Patients with a "currently active" second malignancy other than non-melanoma skin cancers and carcinoma in situ of the cervix are not eligible. Patients are not considered to have a "currently active" second malignancy if they have completed therapy for the second malignancy and are disease free from prior malignancies for >5 years.
    d. Patient has uncontrolled brain metastases, e.g., previously treated brain metastases that is not stable in the last 6 weeks.
    e. Patient has a known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is overall survival, defined as the time from randomization to the time of death from any cause.
    The number of patients with CTCAE Grade 3/4 will be used for the primary safety analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As the data from the Treatment Extension Phase of the protocol will be only descriptive tables, no spend of alpha from the primary or secondary analyses will be required.
    E.5.2Secondary end point(s)
    Safety data in the form of adverse experiences, serious adverse experiences, concomitant medications, study medication, central laboratory assessments, and survival follow-up will be collected for safety follow-up on patients enrolled in the Treatment Extension Phase of the protocol. Descriptive tables that summarize the number and percentage of patients that experience adverse experiences as categorized in the NCI CTCAE version 3.0 will be generated for those patients enrolled in the Treatment Extension Phase of this protocol as part of routine safety monitoring.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety data in the form of adverse experiences, serious adverse experiences, concomitant medications, study medication, central laboratory assessments, and survival follow-up will be collected for safety follow-up on patients enrolled in the Treatment Extension Phase of the protocol. Descriptive tables that summarize the number and percentage of patients that experience adverse experiences as categorized in the NCI CTCAE version 3.0 will be generated for those patients enrolled in the Treatment Extension Phase of this protocol as part of routine safety monitoring.
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Brazil
    Canada
    Germany
    Israel
    Japan
    New Zealand
    Sweden
    Turkey
    United Kingdom
    United States
    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
    Last patient visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state1
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 70
    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)
    NA
    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 Decision2009-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-10-04
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