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    Clinical Trial Results:
    Veliparib (ABT888) and Topotecan (Hycamtin®) for Patients with Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer with Negative or Unknown BRCA Status

    Summary
    EudraCT number
    		 2012-001661-32
    Trial protocol
    		 DK  
    Global end of trial date
    01 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VeTo
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01690598
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vejle Hospital
    Sponsor organisation address
    Beriderbakken 4, Vejle, Denmark,
    Public contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
    Scientific contact
    Clinical Trial Unit, Vejle Hospital, kfe.onko@rsyd.dk
    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
    01 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Phase I: To determine: Maximum-tolerated dose (MTD) Dose-limiting toxicities (DLT) Recommended phase II dose Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status.
    Protection of trial subjects
    Reduction of topotecan dose to 2mg/m2
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2013
    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
    Denmark: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    15
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Phase 1 included from 1 February to 2 October 2013. Phase 2 included from 8 November 2013 to 3 October 2014.

    Pre-assignment
    Screening details
    		 Patients with platinum-resistant or partially platinum-sensitive relapse of epithelial ovarian cancer were screened on an outpatient basis.

    Pre-assignment period milestones
    Number of subjects started
    		 26
    Number of subjects completed
    		 26

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

    Arms
    Arm title
    		 Phase II
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Veliparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg x 2 daily on days 1-3, 8-10, and 15-17

    Investigational medicinal product name
    Topotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Topotecan 2 mg/m² iv over 30 minutes, days 2, 9 and 16 in 28-day cycles.

    Number of subjects in period 1
    		Phase II
    Started
    26
    Completed
    26

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase II
    Reporting group description
    		 -

    Reporting group values
    		 Phase II Total
    Number of subjects
    		 26 26
    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)
    		 15 15
        From 65-84 years
    		 11 11
        85 years and over
    		 0 0
    Gender categorical
    Danish ovarian cancer patients
    Units: Subjects
        Female
    		 26 26
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Phase II
    Reporting group description
    		 -

    Primary: Response rate

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    End point title
    		 Response rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    Every three treatment cycles
    Notes
    [1] - 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: There is only one group and thus statistical analysis is not applicable.
    End point values
    		 Phase II
    Number of subjects analysed
    26
    Units: Fraction
        number (not applicable)
    26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Every 3 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Toxicity
    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: The frequency threshold for reporting non-serious adverse events was not exceeded.
    Serious adverse events
    		 Toxicity
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 26 (46.15%)
         number of deaths (all causes)
    26
         number of deaths resulting from adverse events
    0
    Investigations
    Reduced general condition
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    3 / 26 (11.54%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 26 (11.54%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    3 / 26 (11.54%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Fever
         subjects affected / exposed
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Toxicity
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 26 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 May 2013
    The starting dose of topotecan was not tolerated well and therefore reduced to 2 mg/m2.

    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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