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    Clinical Trial Results:
    A Single Center, Randomized, Phase II Study of the combination of Cisplatin and Gemcitabine with or without Tocilizumab, an IL-6R inhibitor, as first-line treatment in patients with locally advanced or metastatic biliary tract cancer.

    Summary
    EudraCT number
    		 2018-004826-27
    Trial protocol
    		 DK  
    Global end of trial date
    11 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jun 2025
    First version publication date
    08 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GI1863
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Oncology, Herlev & Gentofte Hospital
    Sponsor organisation address
    Borgmester Ib Juuls Vej 1, Herlev, Denmark, 2730
    Public contact
    PI Alice Markussen, Department of Oncology, Herlev & Gentofte Hospital , +45 38686769, alice.markussen.01@regionh.dk
    Scientific contact
    PI Alice Markussen, Department of Oncology, Herlev & Gentofte Hospital , +45 38686769, alice.markussen.01@regionh.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 May 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the efficacy of gemcitabine/cisplatin plus tocilizumab and gemcitabine/cisplatin, primary: To compare survival rate at 12 months of cisplatin-gemcitabine + tocilizumab versus cisplatin-gemcitabine in patients with locally advanced or metastatic BTC
    Protection of trial subjects
    Patients that signed informed consent and fulfilling eligibility criteria were included. Continued monitoring of standard safety parameters during treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Sep 2019
    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: 77
    Worldwide total number of subjects
    77
    EEA total number of subjects
    77
    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)
    35
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was open for recruitment of patients from September 2019 to June 2024. All patients are recruited at a single site: Copenhagen University Hospital - Herlev and Gentofte in Denmark. Trial is prematurely ended due change in treatment guidelines in Denmark for the target population in the trial.

    Pre-assignment
    Screening details
    		 Eligible patients were ≥ 18 years with locally advanced or metastatic biliary tract cancer, inoperable due to extension of the disease and no previous cancer treatment. ECOG PS 0-1, with measurable disease and adequate organ and hematologic function.

    Period 1
    Period 1 title
    Protocol treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Prior to randomised portion of the trial, a safety cohort of 6 participants recieved experimental treatment (unrandomised). Thereafter 71 participants were randomly assigned to experimental and standard treatment, stratification by Serum CRP level (< 10 mg/L versus ≥ 10 mg/L) and stage of disease (locally advanced vs metastatic).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Safety cohort
    Arm description
    		 Gemcitabine and cisplatin in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m2 given i.v. on days 1 and 8 of every 21-day cycle.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will recieve a maximum of 8 cycles with Cisplatin. Each cycle consists of 25 mg/m² i.v. on day 1 and day 8 and is repeated every 21 days.

    Investigational medicinal product name
    Tocilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg given i.v. on day 1, repeated every 21 days

    Arm title
    		 Arm A - Cis/Gem/Toc
    Arm description
    		 Cisplatin and gemcitabine in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m2 given i.v. on days 1 and 8 of every 21-day cycle.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will recieve a maximum of 8 cycles with Cisplatin. Each cycle consists of 25 mg/m² i.v. on day 1 and day 8 and is repeated every 21 days.

    Investigational medicinal product name
    Tocilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/kg given i.v. on day 1, repeated every 21 days

    Arm title
    		 Arm B - Cis/Gem
    Arm description
    		 Cisplatin and gemcitabine. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m2 given i.v. on days 1 and 8 of every 21-day cycle.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients will recieve a maximum of 8 cycles with Cisplatin. Each cycle consists of 25 mg/m² i.v. on day 1 and day 8 and is repeated every 21 days.

    Number of subjects in period 1
    		Safety cohort Arm A - Cis/Gem/Toc Arm B - Cis/Gem
    Started
    6
    35
    36
    Completed
    2
    23
    24
    Not completed
    4
    12
    12
         Adverse event, serious fatal
    -
    -
    1
         Physician decision
    -
    -
    2
         Adverse event, non-fatal
    1
    4
    -
         Surgery for disease under study
    2
    2
    1
         Discontinuation of the trial
    -
    3
    3
         Death of participant
    -
    1
    -
         Patients wish to discontinue treatment
    1
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Safety cohort
    Reporting group description
    		 Gemcitabine and cisplatin in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Arm A - Cis/Gem/Toc
    Reporting group description
    		 Cisplatin and gemcitabine in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Arm B - Cis/Gem
    Reporting group description
    		 Cisplatin and gemcitabine. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group values
    		 Safety cohort Arm A - Cis/Gem/Toc Arm B - Cis/Gem Total
    Number of subjects
    		 6 35 36 77
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3 19 13 35
        From 65-84 years
    		 3 16 23 42
    Age continuous
    Units: years
        median (full range (min-max))
    		 64 (40 to 75) 64 (44 to 80) 68.5 (40 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 3 23 16 42
        Male
    		 3 12 20 35
    Disease stage
    Units: Subjects
        Locally advanced disease
    		 1 10 11 22
        Metastatic disease
    		 5 25 25 55
    CRP level
    Units: Subjects
        CRP < 10mg/l
    		 1 13 15 29
        CRP ≥ 10 mg/l
    		 5 22 21 48

    End points

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    End points reporting groups
    Reporting group title
    Safety cohort
    Reporting group description
    		 Gemcitabine and cisplatin in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Arm A - Cis/Gem/Toc
    Reporting group description
    		 Cisplatin and gemcitabine in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Arm B - Cis/Gem
    Reporting group description
    		 Cisplatin and gemcitabine. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Primary: Overall survival rate at 12 months

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    End point title
    		 Overall survival rate at 12 months [1]
    End point description
    estimates of OS rate as per Kaplan-Meier. Due to premature discontinuation of trial, patients alive at that time were censored at 11/jul/2024 (=EOT+ 30days Safety FU)
    End point type
    Primary
    End point timeframe
    12 months from randomisation
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Safety cohort of 6 patients is not included in the efficacy endpoint, which was analysed for patients in the randomised part of the trial only.
    End point values
    		 Arm A - Cis/Gem/Toc Arm B - Cis/Gem
    Number of subjects analysed
    35
    36
    Units: percent
        number (confidence interval 95%)
    51.6 (32.8 to 67.6)
    51.6 (33.6 to 66.9)
    Statistical analysis title
    		 Log rank test
    Comparison groups
    Arm A - Cis/Gem/Toc v Arm B - Cis/Gem
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.632 [3]
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - Due to premature discontinuation of trial only 71 out of planned 160 patients recruited/included in the analysis
    [3] - Due to premature discontinuation of trial only 71 out of planned 160 patients recruited/included in the analysis

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Time from treatment start to 30 days after last treatment
    Adverse event reporting additional description
    All serious AE are reported. Non serious adverse event are reported if events were assessed with causal relationship to study treatment only.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Safety cohort
    Reporting group description
    		 Gemcitabine and cisplatin in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Arm A - Cis/Gem/Toc
    Reporting group description
    		 Cisplatin and gemcitabine in combination with tocilizumab. Treatment continued until disease progression, unacceptable toxicity, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Reporting group title
    Arm B - Cis/Gem
    Reporting group description
    		 Cisplatin and gemcitabine. Treatment continued until disease progression, unacceptable toxicity, pregnancy, patient’s withdrawal of the informed consent at his/hers own request or investigator’s discretion

    Serious adverse events
    		 Safety cohort Arm A - Cis/Gem/Toc Arm B - Cis/Gem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 6 (83.33%)
    8 / 35 (22.86%)
    18 / 36 (50.00%)
         number of deaths (all causes)
    4
    28
    26
         number of deaths resulting from adverse events
    0
    0
    1
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 35 (2.86%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 35 (5.71%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Stent displacement
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Stroke
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 35 (2.86%)
    5 / 36 (13.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leg pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shoulder pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 35 (2.86%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perforated ulcer
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 35 (2.86%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 35 (2.86%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biloma
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 35 (2.86%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 35 (2.86%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Abscess
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary tract infection
    Additional description: includes terms cholangitis, cholecystitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    5 / 36 (13.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Covid 19 infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection with unknown focus
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Flu
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 35 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety cohort Arm A - Cis/Gem/Toc Arm B - Cis/Gem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    35 / 35 (100.00%)
    36 / 36 (100.00%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    2 / 6 (33.33%)
    19 / 35 (54.29%)
    12 / 36 (33.33%)
         occurrences all number
    2
    43
    13
    Platelet count decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    17 / 35 (48.57%)
    10 / 36 (27.78%)
         occurrences all number
    5
    36
    12
    Vascular disorders
    Thrombophlebits
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 35 (8.57%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3
    2
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    3 / 6 (50.00%)
    11 / 35 (31.43%)
    12 / 36 (33.33%)
         occurrences all number
    4
    18
    16
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 35 (8.57%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3
    2
    Dizziness
         subjects affected / exposed
    3 / 6 (50.00%)
    2 / 35 (5.71%)
    0 / 36 (0.00%)
         occurrences all number
    3
    2
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 6 (16.67%)
    17 / 35 (48.57%)
    22 / 36 (61.11%)
         occurrences all number
    1
    47
    29
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 6 (66.67%)
    17 / 35 (48.57%)
    22 / 36 (61.11%)
         occurrences all number
    8
    27
    31
    Edema limbs
         subjects affected / exposed
    2 / 6 (33.33%)
    17 / 35 (48.57%)
    8 / 36 (22.22%)
         occurrences all number
    5
    27
    10
    Flu like symptoms
         subjects affected / exposed
    1 / 6 (16.67%)
    6 / 35 (17.14%)
    4 / 36 (11.11%)
         occurrences all number
    2
    7
    5
    Fever
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 35 (2.86%)
    4 / 36 (11.11%)
         occurrences all number
    0
    1
    4
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 6 (33.33%)
    15 / 35 (42.86%)
    8 / 36 (22.22%)
         occurrences all number
    4
    20
    9
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 6 (83.33%)
    22 / 35 (62.86%)
    15 / 36 (41.67%)
         occurrences all number
    7
    58
    23
    Constipation
         subjects affected / exposed
    2 / 6 (33.33%)
    18 / 35 (51.43%)
    11 / 36 (30.56%)
         occurrences all number
    2
    26
    11
    Mucositis oral
         subjects affected / exposed
    2 / 6 (33.33%)
    11 / 35 (31.43%)
    7 / 36 (19.44%)
         occurrences all number
    2
    21
    9
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 35 (8.57%)
    2 / 36 (5.56%)
         occurrences all number
    1
    3
    2
    Diarrhea
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 35 (5.71%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 35 (11.43%)
    7 / 36 (19.44%)
         occurrences all number
    0
    5
    9
    Epistaxis
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 35 (5.71%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 6 (50.00%)
    19 / 35 (54.29%)
    8 / 36 (22.22%)
         occurrences all number
    3
    19
    8
    Musculoskeletal and connective tissue disorders
    Athralgia
         subjects affected / exposed
    1 / 6 (16.67%)
    8 / 35 (22.86%)
    9 / 36 (25.00%)
         occurrences all number
    3
    13
    12
    Myalgia
         subjects affected / exposed
    3 / 6 (50.00%)
    4 / 35 (11.43%)
    6 / 36 (16.67%)
         occurrences all number
    3
    5
    7
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    5 / 6 (83.33%)
    10 / 35 (28.57%)
    6 / 36 (16.67%)
         occurrences all number
    7
    19
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Nov 2020
    - Exclusion criterium concerning patients needing a negative blood-based tuberculosis (TB) screening test to be included, was updated to “Evidence of active tuberculosis (TB), or suspected latent TB based on medical history (e.g. history of untreated TB or TB exposure) without a subsequent negative TB test" Furthermore, changes have been made concerning estimated recruitment rate, recruitment period and discontinuation of prophylactic G-CSF treatment upon termination of cisplatin treatment.

    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.
    Premature discontnuation of the trial with only 71 out of planned 160 patients randomised.
    For support, Contact us.
    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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