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    Clinical Trial Results:
    A pilot study of peroral Vorinostat (Zolinza) in patients with refractory histone deacetylase-positive uterine sarcoma.

    Summary
    EudraCT number
    		 2016-000782-22
    Trial protocol
    		 AT  
    Global end of trial date
    06 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Mar 2019
    First version publication date
    27 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SAHA-Pilot-2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Auenbruggerplatz 2, Graz, Austria, 8036
    Public contact
    Trial Center, Medical University of Graz, Department of Obstetrics and Gynecology, 0043 31638581082, edgar.petru@medunigraz.at
    Scientific contact
    Trial Center, Medical University of Graz, Department of Obstetrics and Gynecology, 0043 31638571780, martina.dieber@medunigraz.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main 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.
    Protection of trial subjects
    Close monitoring of blood chemistry and cardiac function according to the study protocol
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Only 3 patients were enrolled. Uterine sarcoma are rated among the very rare diseases. Study was prematuraly closed due to the sluggish patient recruitment and the difficult acquisition of the IMP.

    Pre-assignment
    Screening details
    		 There were no screening failures in the course of the study

    Period 1
    Period 1 title
    Start of treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zolinza (Vorinostat)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg (4 capsules á 100mg of Zolinza) orally once daily with food for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles (treatment period 1) Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients’ withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a 9 months period (treatment periods 2 and 3).

    Number of subjects in period 1
    		Treatment
    Started
    3
    Completed
    1
    Not completed
    2
         Adverse event, serious fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Start of treatment
    Reporting group description
    		 -

    Reporting group values
    		 Start of treatment Total
    Number of subjects
    		 3 3
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 3 3
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    End of period
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Assessment of tumor by CT at the end of a Treatment perid (4 cycles of medication)

    Subject analysis sets values
    		 End of period
    Number of subjects
    1
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    1
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    1
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Subject analysis set title
    End of period
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Assessment of tumor by CT at the end of a Treatment perid (4 cycles of medication)

    Primary: Progression-free survival (PFS) at 3 months

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    End point title
    		 Progression-free survival (PFS) at 3 months
    End point description
    End point type
    Primary
    End point timeframe
    3 months
    End point values
    		 Treatment End of period
    Number of subjects analysed
    1 [1]
    1 [2]
    Units: mm
        number (not applicable)
    3
    1
    Notes
    [1] - 2 patients died before reaching the first end point due to their progressive underlying disease
    [2] - Only 1 patient reached end Point 1 , but was progressive
    Statistical analysis title
    		 PFS
    Statistical analysis description
    Statistical evaluation was not possible as only 1 Patient reached end point 1. The study was prematurately closed
    Comparison groups
    Treatment v End of period
    Number of subjects included in analysis
    2
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.05 [4]
    Method
    		 descriptive
    Confidence interval
    Notes
    [3] - Statistical evaluation was not possible as only 1 Patient reached end point 1.
    [4] - This was a prematurely ended pilot study. Only 3 patients were enrolled. Only 1 patient reached the first primary end Point.(Tumor size Evaluation according to RECIST Version 1.1) No statistical Analysis can be performed

    Primary: PFS at 6 months

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    End point title
    		 PFS at 6 months [5]
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No Patient reached this end point
    End point values
    		 Treatment End of period
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: mm
        number (not applicable)
    Notes
    [6] - No Patient reached end Point 2
    [7] - No Patient reached this end point
    No statistical analyses for this end point

    Primary: PFS at 9 months

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    End point title
    		 PFS at 9 months [8]
    End point description
    End point type
    Primary
    End point timeframe
    9 months
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No Patient reached this end point
    End point values
    		 Treatment End of period
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: mm
        number (not applicable)
    Notes
    [9] - No Patient reached end Point 3
    [10] - No Patient reached end Point 3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Until study completion
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    All study patients
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: All adverse events lead to hospitalisation , therefore were reported as serious adverse events.
    Serious adverse events
    		 All study patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    Reproductive system and breast disorders
    abscess of the vaginal vault
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Death of uterine sarcoma
    Additional description: Death of the underlying disease (refractory uterine sarcoma)
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Respiratory, thoracic and mediastinal disorders
    pleural effusion
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All study patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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