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    Clinical Trial Results:
    GAND-emesis: A multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of palonosetron and dexamethasone plus the neurokinin1-receptor antagonist, fosaprepitant dimeglumine or placebo in patients receiving radiotherapy and concomitant weekly cisplatin.

    Summary
    EudraCT number
    		 2009-014691-21
    Trial protocol
    		 DK   DE  
    Global end of trial date
    24 Apr 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GAND-emesis
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01074697
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J. B. Winsløws vej 2, entrance 140, basement, Odense C, Denmark, 5000
    Public contact
    Ida Coordt Elle, Odense University Hospital, 45 29335922, ida.coordt.elle@rsyd.dk
    Scientific contact
    Christina Ruhlmann, Odense University Hospital, 45 22314446, christina.ruhlmann@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
    27 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to compare an antiemetic regimen consisting of fosaprepitant dimeglumine (Ivemend®), palonosetron (Aloxi®), and dexamethasone (active arm) and a regimen consisting of palonosetron, dexamethasone, and placebo (control arm) with respect to efficacy; the proportion of subjects with no vomiting, i.e. sustained no emesis rate - during five weeks of fractionated (5 days a week) radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
    Protection of trial subjects
    Only PS 0-2 included. Patients were excluded if they had other current malignant diagnoses apart from non-melanoma skin cancers, total neutrophils less than 1·5 × 10⁹ cells per L, platelets less than 100 × 10⁹ cells per L, bilirubin greater than 1·5 times the upper limit of normal (ULN), and aspartate aminotransferase or alanine aminotransferase greater than 2·5 times the ULN.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2010
    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
    Norway: 8
    Country: Number of subjects enrolled
    Denmark: 205
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Australia: 5
    Worldwide total number of subjects
    234
    EEA total number of subjects
    229
    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)
    196
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between June 15, 2010, and March 8, 2015, 246 patients from four countries consented to the study and were randomly assigned. Of these, 234 patients were eligible, having received study medication (118 received fosaprepitant, 116 received placebo).

    Pre-assignment
    Screening details
    		 Eligible patients were 18 years or older, had histologically confirmed cervical cancer, were scheduled to receive fractionated radiotherapy (1.8–2.0 Gy per fraction, five fractions per week to the pelvis) and concomitant weekly cisplatin 40 mg/m² for at least 5 weeks.

    Period 1
    Period 1 title
    Trial period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fosaprepitant
    Arm description
    		 Patients were randomly assigned to receive single doses of fosaprepitant 150 mg intravenously in combination with palonosetron 0·25 mg intravenously and dexamethasone 16 mg orally before cisplatin administration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fosaprepitant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150mg i.v.

    Investigational medicinal product name
    Palonosetron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25mg i.v.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    16 mg

    Arm title
    		 Placebo
    Arm description
    		 Patients were randomly assigned to receive single doses placebo (saline) in combination with palonosetron 0·25 mg intravenously and dexamethasone 16 mg orally before cisplatin administration.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo/saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    NA

    Investigational medicinal product name
    Palonosetron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25mg i.v.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    16 mg

    Number of subjects in period 1
    		Fosaprepitant Placebo
    Started
    118
    116
    Completed
    118
    116

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fosaprepitant
    Reporting group description
    		 Patients were randomly assigned to receive single doses of fosaprepitant 150 mg intravenously in combination with palonosetron 0·25 mg intravenously and dexamethasone 16 mg orally before cisplatin administration.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients were randomly assigned to receive single doses placebo (saline) in combination with palonosetron 0·25 mg intravenously and dexamethasone 16 mg orally before cisplatin administration.

    Reporting group values
    		 Fosaprepitant Placebo Total
    Number of subjects
    		 118 116 234
    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)
    		 99 97 196
        From 65-84 years
    		 19 19 38
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 118 116 234
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Fosaprepitant patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients allocated to Fosaprepitant

    Subject analysis set title
    Placebo patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients allocated to placebo

    Subject analysis sets values
    		 Fosaprepitant patients Placebo patients
    Number of subjects
    118
    116
    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)
    99
    97
        From 65-84 years
    19
    19
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    118
    116
        Male
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Fosaprepitant
    Reporting group description
    		 Patients were randomly assigned to receive single doses of fosaprepitant 150 mg intravenously in combination with palonosetron 0·25 mg intravenously and dexamethasone 16 mg orally before cisplatin administration.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients were randomly assigned to receive single doses placebo (saline) in combination with palonosetron 0·25 mg intravenously and dexamethasone 16 mg orally before cisplatin administration.

    Subject analysis set title
    Fosaprepitant patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients allocated to Fosaprepitant

    Subject analysis set title
    Placebo patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients allocated to placebo

    Primary: Proportion of patients with sustained no emesis

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    End point title
    		 Proportion of patients with sustained no emesis
    End point description
    The proportion of patients with sustained no emesis at 5 weeks (competing risk analysis).
    End point type
    Primary
    End point timeframe
    5 weeks
    End point values
    		 Fosaprepitant Placebo
    Number of subjects analysed
    118
    116
    Units: patients
        number (confidence interval 95%)
    65.7 (42.2 to 89.2)
    48.7 (25.2 to 72.2)
    Statistical analysis title
    		 Fine and Gray’s proportional subhazards model
    Statistical analysis description
    The cumulative incidence of emesis was analysed using Fine and Gray’s proportional subhazards model (competing risk regression).Competing risk (other than patients with emesis, patients completing all five cycles without emesis, or censored events not due to emesis and not competing) was categorised as discontinuation for reasons of study treatment or for any reason.
    Comparison groups
    Placebo v Fosaprepitant
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 two-sided Pearson χ² test with continuit
    Parameter type
    		 cumulative incidence
    Point estimate
    60
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 50
         upper limit
    		 70
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    5 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Fosaprepitant
    Reporting group description
    		 Patients were randomly assigned to receive single doses of fosaprepitant 150 mg intravenously in combination with palonosetron 0·25 mg intravenously and dexamethasone 16 mg orally before cisplatin administration.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients were randomly assigned to receive single doses placebo (saline) in combination with palonosetron 0·25 mg intravenously and dexamethasone 16 mg orally before cisplatin administration.

    Serious adverse events
    		 Fosaprepitant Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 116 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 116 (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
    		 Fosaprepitant Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    118 / 118 (100.00%)
    116 / 116 (100.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 118 (2.54%)
    0 / 116 (0.00%)
         occurrences all number
    3
    0
    Fever
         subjects affected / exposed
    5 / 118 (4.24%)
    4 / 116 (3.45%)
         occurrences all number
    5
    4
    Neutrophil count decreased
         subjects affected / exposed
    6 / 118 (5.08%)
    4 / 116 (3.45%)
         occurrences all number
    6
    4
    Vascular disorders
    Thromboembolic events
         subjects affected / exposed
    0 / 118 (0.00%)
    2 / 116 (1.72%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    57 / 118 (48.31%)
    51 / 116 (43.97%)
         occurrences all number
    57
    51
    Nervous system symptoms
         subjects affected / exposed
    15 / 118 (12.71%)
    19 / 116 (16.38%)
         occurrences all number
    15
    19
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    102 / 118 (86.44%)
    104 / 116 (89.66%)
         occurrences all number
    102
    104
    Headache
         subjects affected / exposed
    55 / 118 (46.61%)
    49 / 116 (42.24%)
         occurrences all number
    55
    49
    Pain
         subjects affected / exposed
    6 / 118 (5.08%)
    4 / 116 (3.45%)
         occurrences all number
    6
    4
    Ear and labyrinth disorders
    Hearing impaired
         subjects affected / exposed
    12 / 118 (10.17%)
    14 / 116 (12.07%)
         occurrences all number
    12
    14
    Tinnitus
         subjects affected / exposed
    24 / 118 (20.34%)
    16 / 116 (13.79%)
         occurrences all number
    24
    16
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    14 / 118 (11.86%)
    18 / 116 (15.52%)
         occurrences all number
    14
    18
    Appetite disorder
         subjects affected / exposed
    56 / 118 (47.46%)
    59 / 116 (50.86%)
         occurrences all number
    56
    59
    Constipation
         subjects affected / exposed
    51 / 118 (43.22%)
    66 / 116 (56.90%)
         occurrences all number
    51
    66
    Diarrhoea
         subjects affected / exposed
    77 / 118 (65.25%)
    72 / 116 (62.07%)
         occurrences all number
    77
    72
    Gastrointestinal tract symptoms
         subjects affected / exposed
    7 / 118 (5.93%)
    12 / 116 (10.34%)
         occurrences all number
    7
    12
    Metabolic alterations
         subjects affected / exposed
    11 / 118 (9.32%)
    5 / 116 (4.31%)
         occurrences all number
    11
    5
    Infections and infestations
    Infections
         subjects affected / exposed
    13 / 118 (11.02%)
    9 / 116 (7.76%)
         occurrences all number
    13
    9

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26952945
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