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    Clinical Trial Results:
    A randomized phase II trial of standard carboplatin-based chemotherapy with or without panitumumab in platinum-sensitive recurrent ovarian cancer

    Summary
    EudraCT number
    		 2010-018849-59
    Trial protocol
    		 DE  
    Global end of trial date
    28 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Sep 2021
    First version publication date
    01 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GMIHO-008/2009_AG56
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    CRO, ClinAssess GmbH, 49 2171363360, info@clinassess.de
    Scientific contact
    CRO, ClinAssess GmbH, 49 2171363360, info@clinassess.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
    23 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of panitumumab plus either the carboplatin/PLD or the carboplatin/gemcitabine combination chemotherapy in k-ras wildtype ovarian cancer patients with platinum-sensitive recurrence, compared to the historical data for the same chemotherapies, which are verified by a randomised control group without the antibody.
    Protection of trial subjects
    The conduct of this study was in compliance with the Good Clinical Practice Guidelines and under the guiding principles detailed in the Declaration of Helsinki. The study was also be carried out in keeping with applicable local law(s) and regulation(s).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2012
    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: 96
    Worldwide total number of subjects
    96
    EEA total number of subjects
    96
    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)
    62
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The clinical trial was conducted at 22 sites in Germany. From March 15, 2012 a total of 102 were randomized in one of two arms (experimental arm A and standard arm B) and two chemotherapy backbone cohorts.

    Pre-assignment
    Screening details
    		 In total, 102 patients were randomised whereof 6 patients were not treated due to withdrawal of consent or other reason. Thus, 96 Patients were treated in 13 study sites. The enrolment period was from April 17, 2012 until May 19, 2015.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 A1: Gem/Carb + Pan
    Arm description
    		 Patients are scheduled to receive a maximum of six cycles, if they do not experience prior progression of disease. In case of no progression, but CR, PR or SD in the experimental arm, patients may receive maintenance therapy with Panitumumab for up to six months. Only patients of arm A are eligible for maintenance therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Gemzar®
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m² on day 1 and 8 of each three-week cycle until progressive disease or for a max. of 6 cycles

    Investigational medicinal product name
    Carboplatin AUC 4
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin AUC 4 (according to the formula by Calvert) on day 1 of each three-week cycle until progressive disease or for a max. of 6 cycles

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Vectibix®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    9 mg/kg/KG on day 1 of each three-week cycle until progressive disease or for a max. of 6 cycles

    Arm title
    		 A2: PLD/Carb + Pan
    Arm description
    		 Patients are scheduled to receive a maximum of six cycles, if they do not experience prior progression of disease. In case of no progression, but CR, PR or SD in the experimental arm, patients may receive maintenance therapy with Panitumumab for up to six months. Only patients of arm A are eligible for maintenance therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pegylated liposomal doxorubicin
    Investigational medicinal product code
    Other name
    Caelyx®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/m² on day 1 of each four-week cycle until progressive disease or for a max. of 6 cycles

    Investigational medicinal product name
    Carboplatin AUC 5
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin AUC 5 (according to the formula by Calvert) on day 1 of each four-week cycle until progressive disease or for a max. of 6 cycles

    Investigational medicinal product name
    Panitumumab
    Investigational medicinal product code
    Other name
    Vectibix®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg/KG on day 1 and day 15 of each four-week cycle until progressive disease or for a max. of 6 cycles

    Arm title
    		 B1: Gem/Carb
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Gemzar®
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m² on day 1 and day 8 of each three-week cycle until progressive disease or for a max. of 6 cycles

    Investigational medicinal product name
    Carboplatin AUC 4
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin AUC 4 (according to the formula by Calvert) on day 1 of each three-week cycle until progressive disease or for a max. of 6 cycles

    Arm title
    		 B2: PLD/Carb
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pegylated liposomal doxorubicin
    Investigational medicinal product code
    Other name
    Caelyx®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/m² on day 1 of each four-week cycle until progressive disease or for a max. of 6 cycles

    Investigational medicinal product name
    Carboplatin AUC 5
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin AUC 5 (according to the formula by Calvert) on day 1 of each four-week cycle until progressive disease or for a max. of 6 cycles

    Number of subjects in period 1
    		A1: Gem/Carb + Pan A2: PLD/Carb + Pan B1: Gem/Carb B2: PLD/Carb
    Started
    23
    26
    19
    28
    Completed
    6
    6
    9
    14
    Not completed
    17
    20
    10
    14
         Adverse event, serious fatal
    1
    1
    2
    -
         Consent withdrawn by subject
    -
    1
    1
    -
         Adverse event, non-fatal
    4
    6
    -
    2
         Not known
    1
    1
    1
    2
         Patient refuses further treatment
    4
    5
    1
    5
         Lost to follow-up
    -
    -
    1
    1
         Lack of efficacy
    7
    6
    4
    3
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 96 96
    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)
    		 62 62
        From 65-84 years
    		 34 34
        85 years and over
    		 0 0
    Age continuous
    Units: days
        median (full range (min-max))
    		 59.7 (31 to 77) -
    Gender categorical
    Units: Subjects
        Female
    		 96 96
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    A1: Gem/Carb + Pan
    Reporting group description
    		 Patients are scheduled to receive a maximum of six cycles, if they do not experience prior progression of disease. In case of no progression, but CR, PR or SD in the experimental arm, patients may receive maintenance therapy with Panitumumab for up to six months. Only patients of arm A are eligible for maintenance therapy.

    Reporting group title
    A2: PLD/Carb + Pan
    Reporting group description
    		 Patients are scheduled to receive a maximum of six cycles, if they do not experience prior progression of disease. In case of no progression, but CR, PR or SD in the experimental arm, patients may receive maintenance therapy with Panitumumab for up to six months. Only patients of arm A are eligible for maintenance therapy.

    Reporting group title
    B1: Gem/Carb
    Reporting group description
    		 -

    Reporting group title
    B2: PLD/Carb
    Reporting group description
    		 -

    Primary: Progression-free survival (PFS) rate after 12 months

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    End point title
    		 Progression-free survival (PFS) rate after 12 months
    End point description
    PFS is defined as the duration from the date of randomisation to the date of progressive disease (acc. to RECIST 1.1) or death, whichever occurs first.
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 A1: Gem/Carb + Pan A2: PLD/Carb + Pan B1: Gem/Carb B2: PLD/Carb
    Number of subjects analysed
    23
    26
    19
    28
    Units: percent
        number (confidence interval 95%)
    26.1 (10.2 to 48.4)
    30.8 (14.3 to 51.8)
    31.6 (12.6 to 56.6)
    28.6 (13.2 to 48.7)
    Statistical analysis title
    		 Full Analysis
    Comparison groups
    A1: Gem/Carb + Pan v A2: PLD/Carb + Pan v B2: PLD/Carb v B1: Gem/Carb
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.9999
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Overall response rate

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    End point title
    		 Overall response rate
    End point description
    Overall response is defined as best response from start of cycle one unitl the end of last cycle with background chemotherapy and/ or Panitumumab plus 28 days. Patients experiencing CR or PR are considered to be responders. Overall response was assessed during combination chemotherapy in cycle 3 and cycle 6 as well as at the end of combination chemotherapy. In case of maintenance therapy, overall response was scheduled after every 12 weeks. During follow-up response was assessed every third month.
    End point type
    Secondary
    End point timeframe
    cycle 3, cycle 6, end of combination chemotherapy, every 12 weeks (maintenance therapy), every third month (follow-up)
    End point values
    		 A1: Gem/Carb + Pan A2: PLD/Carb + Pan B1: Gem/Carb B2: PLD/Carb
    Number of subjects analysed
    23
    22
    19
    27
    Units: percent
        number (confidence interval 95%)
    69.6 (47.1 to 86.8)
    50.0 (28.2 to 71.8)
    36.8 (16.3 to 61.6)
    29.6 (13.8 to 50.2)
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response
    End point description
    End point type
    Secondary
    End point timeframe
    time of disease progression or death
    End point values
    		 A1: Gem/Carb + Pan A2: PLD/Carb + Pan B1: Gem/Carb B2: PLD/Carb
    Number of subjects analysed
    9
    5
    4
    3
    Units: percent
        number (not applicable)
    81.8
    100.0
    80.0
    50.0
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    End point type
    Secondary
    End point timeframe
    date of progressive disease or death
    End point values
    		 A1: Gem/Carb + Pan A2: PLD/Carb + Pan B1: Gem/Carb B2: PLD/Carb
    Number of subjects analysed
    19
    20
    14
    17
    Units: month
        median (confidence interval 95%)
    8.9 (7.9 to 12.4)
    10.5 (8.5 to 12.2)
    10.6 (7.1 to 13.1)
    10.9 (8.5 to 15.4)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    date of death
    End point values
    		 A1: Gem/Carb + Pan A2: PLD/Carb + Pan B1: Gem/Carb B2: PLD/Carb
    Number of subjects analysed
    8
    12
    4
    5
    Units: percent
        number (not applicable)
    34.8
    46.2
    21.1
    17.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from first intake of study medication until 28 days after last intake of any study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Most frequent events
    Reporting group description
    		 -

    Serious adverse events
    		 Most frequent events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    47 / 96 (48.96%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    47 / 96 (48.96%)
         occurrences causally related to treatment / all
    6 / 13
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    47 / 96 (48.96%)
         occurrences causally related to treatment / all
    11 / 18
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    47 / 96 (48.96%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Most frequent events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    95 / 96 (98.96%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    46 / 96 (47.92%)
         occurrences all number
    186
    Leukopenia
         subjects affected / exposed
    47 / 96 (48.96%)
         occurrences all number
    197
    Neutropenia
         subjects affected / exposed
    49 / 96 (51.04%)
         occurrences all number
    204
    Thrombocytopenia
         subjects affected / exposed
    52 / 96 (54.17%)
         occurrences all number
    221
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    57 / 96 (59.38%)
         occurrences all number
    107
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    33 / 96 (34.38%)
         occurrences all number
    48
    Diarrhoea
         subjects affected / exposed
    35 / 96 (36.46%)
         occurrences all number
    59
    Nausea
         subjects affected / exposed
    65 / 96 (67.71%)
         occurrences all number
    102
    Vomiting
         subjects affected / exposed
    33 / 96 (34.38%)
         occurrences all number
    49
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    30 / 96 (31.25%)
         occurrences all number
    52
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    32 / 96 (33.33%)
         occurrences all number
    35
    Dry skin
         subjects affected / exposed
    31 / 96 (32.29%)
         occurrences all number
    52

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Apr 2012
    Amendment1: Addition of an alternative chemotherapy backbone constisting of Gemcitabin and Carboplatin as possible replacement for the PLD/Carboplatin chemotherapy with the option to switch back (for new patients) to the PLD/Carboplatin-regime, if PLD becomes available during the course of the trial.
    17 Oct 2012
    Amendment 2: CRO change
    16 Jul 2013
    Amendment 3: IB update Panitumumba (version 12.0); amended Protocol (Version 3.0) - modification of chemotherapy dose levels and deletion of translational research program
    24 Nov 2014
    Amendment 4: amended Protocol (version 4.0) - reduction of the number of patients and adjustment if the sample size, extension of study duration

    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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