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    Summary
    EudraCT Number:2016-000782-22
    Sponsor's Protocol Code Number:SAHA-Pilot-2016
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-12-07
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-000782-22
    A.3Full title of the trial
    A pilot study of peroral Vorinostat (Zolinza) in patients with refractory histone deacetylase-positive uterine sarcoma.
    Vorinostat (Zolinza) zur Behandlung von Patientinnen mit einem fortgeschrittenen, therapieresistenten, Histon-Deacetylase-positiven uterinen Sarkom - eine Pilotstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study about the effects of the drug Vorinostat (Zolinza) in patients with a previously treated, recurring special form of uterine cancer (sarcoma).
    Vorinostat (Zolinza) zur Behandlung von Patientinnen mit einer bereits vorbehandelten, wiedergekehrten speziellen Form von Gebärmutterkrebs (Sarkom).
    A.3.2Name or abbreviated title of the trial where available
    SAHA-Pilot-2016
    SAHA-Pilot-2016
    A.4.1Sponsor's protocol code numberSAHA-Pilot-2016
    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 SponsorMedical University of Graz
    B.1.3.4CountryAustria
    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 supportMedical University of Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz, Department of Obstetrics and Gynecology
    B.5.2Functional name of contact pointTrial Center
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 14
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number00433163804402
    B.5.6E-mailmartina.dieber@medunigraz.at
    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.2.1.1.2Name of the Marketing Authorisation holderMerck & Co., Inc. (MSD)
    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
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 149647-78-9
    D.3.9.3Other descriptive nameVORINOSTAT, SAHA
    D.3.9.4EV Substance CodeSUB23356
    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 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
    Uterine sarcoma
    Uterussarkom
    E.1.1.1Medical condition in easily understood language
    A special form of uterine cancer
    Eine spezielle Form von Gebärmutterkrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main purpose is to test the efficacy of the hydroxamic acid-based HDAC inhibitor Vorinostat as monotherapy in patients with histone deacetylase-positive, progressive, metastatic uterine sarcomas after prior anti-proliferative therapy.
    Das Hauptziel ist eine Evaluierung der Wirksamkeit des HDAC-Inhibitors Vorinostat bei der Therapie von Patientinnen mit antiproliferativ vorbehandeltem, rezidiviertem Uterussarkom.
    E.2.2Secondary objectives of the trial
    Evaluation of safety and toxicity
    Evaluierung der Sicherheit und Toxizität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of metastatic uterine sarcoma
    - High HDAC-positivity of the tumor determined by IHC
    - Prior systemic antineoplastic therapy for metastatic disease
    -Patient not amenable for curative therapy
    - Women, age >= 18 years
    - Life expectancy > 3 months
    - Measurable (> 1cm) or non-measurable (but radiologically evaluable) disease per RECIST version 1.1 on computed tomography (CT) scan or MRT scan?
    - Karnofsky performance status of 60-100
    - Written informed consent
    - Subject is able to swallow and retain oral medication and does not have uncontrolled emesis
    - Adequate bone marrow reserve, liver and kidney function
    - Adequate hematologic, renal and hepatic function
    - No fertility preserved
    • Histologisch nachgewiesenes Uterussarkom
    • Immunhistolgisch bestätigtes Vorhandensein von HDAC im Tumor
    • Bereits erfolgte antineoplastische Therapie
    • Patientin spricht nicht auf eine kurative Therapie an
    •Alter über 18 Jahre
    •Voraussichtliche Überlebensdauer von über drei Monaten
    •Messbare Läsionen (>1cm), bzw. durch radiologische Verfahren evaluierbares Krankheitsgeschehen
    •Karnofsky Status 60-100
    • informierte Einwilligungserklärung
    • Patientin ist in der Lage, die Studienmedikation zu schlucken; kein unkontrolliertes Erbrechen
    • Adäquate Knochenmark-, Leber- und Nierenfunktion
    • Adäquate hämatologische Funktionen
    • Infertilität
    E.4Principal exclusion criteria
    - Lack of or low expression of HDAC of the tumor determined by IHC
    - Significant cardiac disease
    - Other invasive malignant tumor diagnosed within the last 5 years (e.g. metastases from breast cancer in the last 3 years)
    - Significant bowel obstruction
    - Severe uncontrolled active infection
    - Known HIV-positivity
    - Symptomatic brain metastasis or leptomeningeal disease
    - Pre-existing liver disease, severe hepatic impairment (Bilirubin no greater than 1.5 times upper limit of normal (ULN) and/or AST/ALT greater than 2.5 times ULN
    - Known history of allergic reaction to vorinostat or similar medications
    - Received systemic therapy or an investigational agent within 21 days prior to study inclusion
    - Uncontrolled hypertension (sustained systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg despite optimal medical Management)
    - Major surgery within 3 weeks of enrollment when diagnosed at an early stage.
    - Symptomatic congestive heart failure
    - Unstable angina pectoris or cardiac arrhythmia
    - Myocardial infarction within last 6 months
    - Known active hepatitis B or hepatitis C
    - Psychiatric illness/social situations that would limit compliance with study requirements

    • Unzureichendes Vorhandensein von HDAC im Tumor
    • Signifikante Herzerkrankung
    • ein weiterer invasiver maligner Tumor innerhalb der letzten fünf bzw. drei Jahre (bei Metastasen von Brustkrebs)
    • Vorliegen signifikanter Darmobstruktionnen
    • Schwerwiegende nicht-kontrollierbare Infektion
    • HIV-Infektion
    • Symptomatische Hirnmetastasen, Erkrankung der Leptomeningen
    • Signifikante Lebererkrankung bzw. Leberfunktionsstörungen
    • bekannte Unverträglichkeiten gegen Vorinostat oder ähnliche Arzneimittel
    • Patientin hat eine systemische Therapie oder eine Behandlung mit dem zu untersuchenden Arzneimittel innerhalb der letzten 21 Tage vor Einschluss in die Studie erhalten.
    • Unkontrollierbare Hypertonie
    • Schwerwiegende Operation innerhalb von drei Wochen vor Einschluss in die Studie
    • Symptomatische Herzinsuffizienz
    • Instabile Angina pectoris oder Herzrhythmusstörungen
    • Myokardinfarkt während der letzten 6 Monate vor Einschluss
    • Aktive Hepatitis B oder C
    • Psychiatrische Erkrankung bzw. andere Situationen, die die Compliance der Patientin beeinträchtigen könnten.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) at 3, 6 and 9 months
    Progressionsfreies Überleben nach 3, 6 und 9 Monaten
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three, six and nine months
    Drei, sechs und neun Monate
    E.5.2Secondary end point(s)
    Safety and toxicity
    Sicherheit und Toxizität
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three, six, nine months
    Drei, sechs und neun Monate
    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 Yes
    E.8.1.7.1Other trial design description
    Pilotstudie
    Pilot study
    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 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 No
    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
    LVLS
    Letzte Studienvisite des letzten Patienten
    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 months3
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state8
    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)
    Since there is no generally applicable therapeutic standard for this patient collective, all patients will be treated individually after their participation in the trial has ended.
    Da für das betroffene Patientinnenkollektiv kein allgemein gültiger Therapiestandard existiert, werden die Patientinnen nach Beendigung der Studie individuell weiterbehandelt.
    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 Decision2017-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-02-04
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