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    Clinical Trial Results:
    A Double-blind, Placebo-controlled, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of Maintenance Therapy With PankoMab-GEX™ After Chemotherapy in Patients With Recurrent Epithelial Ovarian Carcinoma

    Summary
    EudraCT number
    		 2013-000931-28
    Trial protocol
    		 IT   DE   HU   ES   GB   PL  
    Global end of trial date
    28 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2020
    First version publication date
    16 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GEXMab25201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01899599
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Glycotope GmbH
    Sponsor organisation address
    Robert Roessle St 10, Berlin, Germany, 13125
    Public contact
    Reception desk, Glycotope GmbH, +49 3094892600, Trials@glycotope.com
    Scientific contact
    Reception desk, Glycotope GmbH, +49 3094892600, Trials@glycotope.com
    Sponsor organisation name
    Glycotope GmbH
    Sponsor organisation address
    Robert-Rössle-Str. 10, Berlin, Germany, 13125
    Public contact
    Isabelle Ahrens-Fath, PhD, Glycotope GmbH, +49 3094892600, isabelle.ahrens-fath@glycotope.com
    Scientific contact
    Isabelle Ahrens-Fath, PhD, Glycotope GmbH, +49 3094892600, isabelle.ahrens-fath@glycotope.com
    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
    08 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jul 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary study objective is: To evaluate the efficacy of maintenance therapy with single-agent PankoMab-GEX™ compared to placebo as assessed by progression free survival (PFS) following chemotherapy in patients with recurrent epithelial ovarian carcinoma.
    Protection of trial subjects
    The protocol (and any amendments) and the statement of informed consent were approved by an independent ethics committee (IEC) prior to each center’s Initiation. The study was conducted in accordance with the Declaration of Helsinki and its revisions as well as with the valid national law(s) of the participating country/ies, with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice (GCP) (E6) issued in July 1996, and with the Directive 2001/20/EC and Regulation EU No 536/2014. Each investigator conducted the study according to applicable local or regional regulatory requirements and applicable national regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jul 2013
    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
    Poland: 36
    Country: Number of subjects enrolled
    Spain: 29
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Italy: 37
    Country: Number of subjects enrolled
    Russian Federation: 35
    Country: Number of subjects enrolled
    Romania: 22
    Worldwide total number of subjects
    216
    EEA total number of subjects
    181
    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)
    131
    From 65 to 84 years
    84
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 At Pre-screening, the general eligibility of the patients for study participation was assessed by confirmation of TA-MUC 1 +, recurrent epithelial ovarian or fallopian-tube cancer, or primary peritoneal cancer with high-grade (Grade 2 or 3) serous features or a serous component.

    Pre-assignment
    Screening details
    		 Patients had to have recurrent epithelial primary ovarian, fallopian tube, or high grade primary peritoneal cancer, immune-histologically confirmed as TA-MUC1-positive (immuno-reactive score [IRS] ≥3). Patients had to have received at least 2 lines but not more than 5 lines of chemotherapy prior to the start of maintenance treatment.

    Pre-assignment period milestones
    Number of subjects started
    		 216
    Number of subjects completed
    		 216

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    Patients who met all of the eligibility criteria for the study were randomized by centralized IWRS in a 2:1-ratio to receive either PankoMab-GEX™ or placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pankomab-GEX
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pankomab-GEX
    Investigational medicinal product code
    Other name
    Gatipotuzumab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received a starting dose of 500 mg PankoMab-GEX™ on Day 1 of the study (start of Cycle 0). Thereafter, PankoMab-GEX™ (1700 mg) was administered on the first day of each 3-week treatment cycle, starting on Day 8 after randomization (start of Cycle 1). Patients continued to receive treatment with a 3-week interval (q3w) ± 3 days until disease progression (according modified RECIST V1.1 irRC; i.e. increase of CA125 alone was no criterion for disease progression) or until they exhibited any discontinuation criteria.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Route of administration: i.v. over 3 hours matching Pankomab-GEX

    Number of subjects in period 1
    		Pankomab-GEX Placebo
    Started
    151
    65
    Completed
    133
    55
    Not completed
    18
    10
         Consent withdrawn by subject
    4
    3
         Adverse event, non-fatal
    2
    3
         not specified
    12
    2
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pankomab-GEX
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Pankomab-GEX Placebo Total
    Number of subjects
    		 151 65 216
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 92 40 132
        From 65-84 years
    		 58 25 83
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 61.0 (34 to 86) 60.0 (29 to 79) -
    Gender categorical
    Based on the indication "Ovarian Cancer" only female patients participated in the study
    Units: Subjects
        Female
    		 151 65 216
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Intent-to-treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population was defined as all randomized patients - patients were analyzed as randomized. Three patients were randomized ( One patient in the placebo group and two patients in the PankoMab-GEX™ group) but were excluded from the ITT population because of the lack of signature on the consent form.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population was defined as all randomized patients having received IMP at least once

    Subject analysis sets values
    		 Intent-to-treat population Safety population
    Number of subjects
    213
    212
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    130
    129
        From 65-84 years
    82
    82
        85 years and over
    1
    1
    Age continuous
    Units: years
        median (full range (min-max))
    61.0 (29 to 86)
    61.0 (29 to 86)
    Gender categorical
    Based on the indication "Ovarian Cancer" only female patients participated in the study
    Units: Subjects
        Female
    213
    212
        Male
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Pankomab-GEX
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Intent-to-treat population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population was defined as all randomized patients - patients were analyzed as randomized. Three patients were randomized ( One patient in the placebo group and two patients in the PankoMab-GEX™ group) but were excluded from the ITT population because of the lack of signature on the consent form.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population was defined as all randomized patients having received IMP at least once

    Primary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    PFS, as assessed by the site investigator and defined as the time interval from the date of randomization to the first date of documented disease progression using modified irRC based on RECIST, or death due to any cause.
    End point type
    Primary
    End point timeframe
    Time interval from the date of randomization to the first date of documented disease progression using modified irRC based on RECIST version 1.1 , or death due to any cause
    End point values
    		 Pankomab-GEX Placebo
    Number of subjects analysed
    149
    64
    Units: weeks
        median (confidence interval 95%)
    15.286 (14.286 to 20.143)
    15.000 (13.143 to 20.486)
    Statistical analysis title
    		 Cox Proportional Hazards Model
    Comparison groups
    Pankomab-GEX v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8003
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.959
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.69
         upper limit
    		 -

    Secondary: Progression Free Survival (central assssment)

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    End point title
    		 Progression Free Survival (central assssment)
    End point description
    PFS, as assessed by Independent central review and defined as the time interval from the date of randomization to the first date of documented disease progression using modified irRC based on RECIST, or death due to any cause.
    End point type
    Secondary
    End point timeframe
    Time interval from the date of randomization to the first date of documented disease progression using modified irRC based on RECIST version 1.1 , or death due to any cause
    End point values
    		 Pankomab-GEX Placebo
    Number of subjects analysed
    149
    64
    Units: weeks
        median (confidence interval 95%)
    14.14 (8.71 to 14.43)
    14.14 (8.57 to 15.29)
    Statistical analysis title
    		 Cox proportional Hazards Model
    Comparison groups
    Pankomab-GEX v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7972
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.047
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.739
         upper limit
    		 1.482

    Secondary: Progression Free Survival (GCIC criteria)

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    End point title
    		 Progression Free Survival (GCIC criteria)
    End point description
    PFS as assessed according to Gynecologic Cancer Intergroup (GCIG) criteria
    End point type
    Secondary
    End point timeframe
    Time interval from the date of randomization to the first date of documented disease progression or death due to any cause
    End point values
    		 Pankomab-GEX Placebo
    Number of subjects analysed
    149
    64
    Units: weeks
        median (confidence interval 95%)
    29.00 (23.71 to 47.14)
    22.29 (16.43 to 51.14)
    Statistical analysis title
    		 Cox Proportional Hazards Model
    Comparison groups
    Pankomab-GEX v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1368
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.704
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.443
         upper limit
    		 1.118

    Secondary: Objective Response Rate

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    End point title
    		 Objective Response Rate
    End point description
    The ORR was defined as the combined rate of best response of CR or PR as assessed by investigator
    End point type
    Secondary
    End point timeframe
    From randomization until end of treatment
    End point values
    		 Pankomab-GEX Placebo
    Number of subjects analysed
    149
    64
    Units: Percent
        number (confidence interval 95%)
    3.36 (1.10 to 7.66)
    6.25 (1.73 to 15.24)
    Statistical analysis title
    		 Fisher exact test
    Comparison groups
    Placebo v Pankomab-GEX
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4573
    Method
    		 Fisher exact
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.45
         upper limit
    		 11.71

    Secondary: Clinical Benefit Rate

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    End point title
    		 Clinical Benefit Rate
    End point description
    The CBR was defined as Best Overall Response of CR, PR, and SD
    End point type
    Secondary
    End point timeframe
    From randomization until end of treatment
    End point values
    		 Pankomab-GEX Placebo
    Number of subjects analysed
    149
    64
    Units: Percent
        number (confidence interval 95%)
    60.40 (52.07 to 68.31)
    57.81 (44.82 to 70.06)
    Statistical analysis title
    		 Cochran-Mantel-Haenszel
    Comparison groups
    Pankomab-GEX v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7872
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization until end of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Pankomab-GEX
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Pankomab-GEX Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 149 (9.40%)
    8 / 63 (12.70%)
         number of deaths (all causes)
    0
    3
         number of deaths resulting from adverse events
    0
    2
    Investigations
    Blood creatine increased
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Seroma
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure acute
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periardial effusion
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 149 (0.67%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infections and infestations
    Device related infection
         subjects affected / exposed
    2 / 149 (1.34%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 149 (1.34%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 149 (0.67%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 149 (0.67%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pankomab-GEX Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    130 / 149 (87.25%)
    51 / 63 (80.95%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 149 (6.04%)
    3 / 63 (4.76%)
         occurrences all number
    10
    3
    Flushing
         subjects affected / exposed
    9 / 149 (6.04%)
    1 / 63 (1.59%)
         occurrences all number
    9
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    23 / 149 (15.44%)
    9 / 63 (14.29%)
         occurrences all number
    36
    9
    Dizziness
         subjects affected / exposed
    12 / 149 (8.05%)
    2 / 63 (3.17%)
         occurrences all number
    14
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    25 / 149 (16.78%)
    6 / 63 (9.52%)
         occurrences all number
    55
    6
    Asthenia
         subjects affected / exposed
    19 / 149 (12.75%)
    8 / 63 (12.70%)
         occurrences all number
    23
    9
    Fatigue
         subjects affected / exposed
    21 / 149 (14.09%)
    5 / 63 (7.94%)
         occurrences all number
    24
    6
    Chills
         subjects affected / exposed
    8 / 149 (5.37%)
    4 / 63 (6.35%)
         occurrences all number
    13
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    27 / 149 (18.12%)
    13 / 63 (20.63%)
         occurrences all number
    36
    17
    Nausea
         subjects affected / exposed
    25 / 149 (16.78%)
    10 / 63 (15.87%)
         occurrences all number
    46
    12
    Vomiting
         subjects affected / exposed
    18 / 149 (12.08%)
    8 / 63 (12.70%)
         occurrences all number
    24
    17
    Diarrhoea
         subjects affected / exposed
    17 / 149 (11.41%)
    6 / 63 (9.52%)
         occurrences all number
    23
    8
    Abdominal pain upper
         subjects affected / exposed
    10 / 149 (6.71%)
    5 / 63 (7.94%)
         occurrences all number
    7
    3
    Constipation
         subjects affected / exposed
    11 / 149 (7.38%)
    3 / 63 (4.76%)
         occurrences all number
    15
    3
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    19 / 149 (12.75%)
    3 / 63 (4.76%)
         occurrences all number
    24
    3
    Cough
         subjects affected / exposed
    12 / 149 (8.05%)
    5 / 63 (7.94%)
         occurrences all number
    15
    5
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    21 / 149 (14.09%)
    4 / 63 (6.35%)
         occurrences all number
    28
    4
    Erythema
         subjects affected / exposed
    15 / 149 (10.07%)
    5 / 63 (7.94%)
         occurrences all number
    20
    7
    Rash
         subjects affected / exposed
    10 / 149 (6.71%)
    2 / 63 (3.17%)
         occurrences all number
    14
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    8 / 149 (5.37%)
    4 / 63 (6.35%)
         occurrences all number
    9
    5
    Insomnia
         subjects affected / exposed
    8 / 149 (5.37%)
    3 / 63 (4.76%)
         occurrences all number
    9
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    15 / 149 (10.07%)
    4 / 63 (6.35%)
         occurrences all number
    16
    20
    Arthralgia
         subjects affected / exposed
    11 / 149 (7.38%)
    5 / 63 (7.94%)
         occurrences all number
    14
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    12 / 149 (8.05%)
    6 / 63 (9.52%)
         occurrences all number
    14
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2016
    # Addition of disease assessment according to RECIST 1.1 criteria # Introduction of the definition of study termination # Changes in study design: An open label portion was added to the study after the primary analysis in order to collect more robust data for overall survival and safety endpoints.

    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
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