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    Clinical Trial Results:
    Double-blind, placebo-controlled multicenter phase II trial to evaluate the efficacy and safety of romiplostim for the treatment of chemotherapy-induced thrombocytopenia in subjects with relapsed ovarian cancer (2nd or further line)

    Summary
    EudraCT number
    		 2013-002564-69
    Trial protocol
    		 DE  
    Global end of trial date
    26 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2022
    First version publication date
    13 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    410/56
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03622931
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
    Sponsor organisation address
    Almstadtstraße 7, Berlin, Germany, 10119
    Public contact
    Medical Consulting, GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH, 0049 35125933100, info@gmiho.de
    Scientific contact
    Europäisches Kompetenzzentrum für Eierstockkrebs (EKZE) Studiensekretariat, Charité Campus Virchow-Klinikum Universitätsmedizin Berlin, 0049 30450564052, studiensekretariat.agovarialca@charite.de
    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
    20 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Feb 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of secondary chemotherapy-induced thrombocytopenia prophylaxis with romiplostim in ovarian cancer subjects receiving myelosuppressive chemotherapy, with respect to platelet suppression during the first romiplostim/placebo cycle.
    Protection of trial subjects
    The conduct of this study was in compliance with the Good Clinical Praactice Guidelines and under the guiding principles detailed in the Declaration of Helsinki. The study was also carried out in keeping with applicable local law(s) and regulation(s). In order to assure adequate toxicity assessment, an independent DSMB was established for analysis of safety. The board met for the first time after ten patients were included in each arm
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    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)
    13
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From March 2015 until February 2018 a total of 23 patients was screened for inclusion at 8 study sites in Germany. It was planned to include 74 patients (approx. 37 patients each in experimental and placebo arm).

    Pre-assignment
    Screening details
    		 21 patients were registered; 11 patients were randomized to experimental arm A and 10 patients to placebo arm B.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    Patients were randomized by an online procedure at a 1:1 ratio to group A (experimental arm) and group B (control arm). The treatment allocation and the respective information regarding the vial number was obtained from computer–generated randomization lists (one per stratum) with permuted blocks of randomly variable size. Each block length was 4 and the number of blocks was 12 per stratum. Randomization was stratified according to combination-chemotherapy vs. monotherapy.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Standard chemotherapy + romiplostim
    Arm type
    		 Experimental

    Investigational medicinal product name
    Romiplostim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received standard chemotherapy + romiplostim 750 μg. Romiplostim was administered on day 1, 8, 15 (+/- 1 day) of a three-weekly chemotherapy regimen, and in case of a four-weekly regime on day 1, 8, 15 with a break between day 22 – 28.

    Arm title
    		 Arm B
    Arm description
    		 Chemotherapy + placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received standard chemotherapy + matching placebo. Placebo was administered on day 1, 8, 15 (+/- 1 day) of a three-weekly chemotherapy regimen, and in case of a four-weekly regime on day 1, 8, 15 with a break between day 22 – 28.

    Number of subjects in period 1
    		Arm A Arm B
    Started
    11
    10
    Completed
    8
    10
    Not completed
    3
    0
         randomized but no IMP administration
    1
    -
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Standard chemotherapy + romiplostim

    Reporting group title
    Arm B
    Reporting group description
    		 Chemotherapy + placebo

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 11 10 21
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 6 7 13
        From 65-84 years
    		 5 3 8
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 10 21
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Standard chemotherapy + romiplostim

    Reporting group title
    Arm B
    Reporting group description
    		 Chemotherapy + placebo

    Primary: Rate of grade 3/4 thrombocytopenia (nadir value)

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    End point title
    		 Rate of grade 3/4 thrombocytopenia (nadir value)
    End point description
    End point type
    Primary
    End point timeframe
    on days 8, 11 or 12, 15 and 18 or 19
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    8
    10
    Units: percent
        number (confidence interval 95%)
    0.00 (0.00 to 39.94)
    60.00 (26.24 to 87.84)
    Statistical analysis title
    		 Efficacy analysis
    Comparison groups
    Arm B v Arm A
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.0036
    Method
    		 One-sided Cochran-Armitage Trend Test
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    on days 8, 11 or 12, 15 and 18 or 19 (days 18 or 19 are optional after cycle 1) and 30 days after last application of study treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Frequency threshold for reporting non-serious adverse events: 1%
    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: In total, 220 AEs were reported (104 in arm A and 116 in arm B). Platelet count decreased was the most frequently reported AE (arm A: n=5 [50%], arm B: n=9 [90%]). Platelet count decreased was severe or life-threatening (grade 3/4) in two of the five patients of arm A and in all nine patients of arm B. AEs were more frequently related to chemotherapy than to study treatment (romiplostim/placebo). Six patients (arm A: n=2, arm B: n=4) experienced SAEs.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Mar 2016
    Amendment No. 01 dated 16/02/2016: change of study title from "2nd and 3rd line" to "2nd and further line"; change of exclusion criteria; specification of indication, change of time point of the first meeting of Data Safety and Monitoring Board (DSMB)

    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.
    Due to slow recruitment and the results of the interim analysis, the study was prematurely discontinued on 17 JAN 2019.
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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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