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    Clinical Trial Results:
    Phase II, Exploratory, Multicenter, Non Randomized, Single Agent Cohort Study to Determine Best Tumor Response With Trastuzumab Emtansine in HER2 Overexpressing Solid Tumors

    Summary
    EudraCT number
    		 2015-001377-40
    Trial protocol
    		 ES   SK   NL   IT  
    Global end of trial date
    10 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2019
    First version publication date
    25 Apr 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MO29694
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02999672
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Medical Communications, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    Medical Communications, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.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
    10 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of trastuzumab emtansine.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Oct 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Spain: 9
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    12
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 315 patients were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 (UBC)
    Arm description
    		 First six participants with locally advanced (unresectable and not treatable with curative intent) or metastatic UBC initially received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab Emtansine
    Investigational medicinal product code
    Other name
    Kadcyla
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trastuzumab emtansine will be administered as Regimen A (2.4 mg/kg qw via IV infusion) or Regimen B (3.6 mg/kg q3w via IV infusion) until unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

    Arm title
    		 Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Arm description
    		 First six participants with metastatic pancreatic cancer/cholangiocarcinoma received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab Emtansine
    Investigational medicinal product code
    Other name
    Kadcyla
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trastuzumab emtansine will be administered as Regimen A (2.4 mg/kg qw via IV infusion) or Regimen B (3.6 mg/kg q3w via IV infusion) until unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

    Number of subjects in period 1
    		Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Started
    13
    7
    Completed
    0
    0
    Not completed
    13
    7
         Adverse event, non-fatal
    4
    -
         Progressive Disease
    9
    6
         Study Terminated by Sponsor
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 (UBC)
    Reporting group description
    		 First six participants with locally advanced (unresectable and not treatable with curative intent) or metastatic UBC initially received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).

    Reporting group title
    Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Reporting group description
    		 First six participants with metastatic pancreatic cancer/cholangiocarcinoma received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).

    Reporting group values
    		 Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma) Total
    Number of subjects
    		 13 7 20
    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)
    		 7 5 12
        From 65-84 years
    		 6 2 8
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 57.5 ( 14.1 ) 62.9 ( 7.2 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 1 3 4
        Male
    		 12 4 16
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 0 2
        Not Hispanic or Latino
    		 9 7 16
        Unknown or Not Reported
    		 2 0 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 12 7 19
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 (UBC)
    Reporting group description
    		 First six participants with locally advanced (unresectable and not treatable with curative intent) or metastatic UBC initially received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).

    Reporting group title
    Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Reporting group description
    		 First six participants with metastatic pancreatic cancer/cholangiocarcinoma received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).

    Primary: Best Overall Response (BOR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).

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    End point title
    		 Best Overall Response (BOR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). [1]
    End point description
    BOR is defined as the best response recorded from the first day of study treatment until disease progression/recurrence or death. Responders, as assessed every 6 weeks, were defined based on tumor assessment status as partial responder (PR) or complete responder (CR) at these time points. To be assigned a status of PR or CR (i.e.,a responder), changes in tumor measurements had to be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response were first met, i.e., patients needed to have 2 consecutive assessments of PR or CR to be a responder.
    End point type
    Primary
    End point timeframe
    Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Due to early termination of the study, all statistical analyses were based only on descriptive statistics, including confidence intervals as relevant.
    End point values
    		 Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Number of subjects analysed
    13
    7
    Units: Percentage of Treated Participants
    number (not applicable)
        CR
    0
    0
        PR
    38.5
    14.3
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS was defined as the time from beginning of treatment to the first occurrence of disease progression, as determined by the investigator (uding RECIST 1.1), or death from any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months)
    End point values
    		 Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Number of subjects analysed
    13
    7
    Units: Months
        median (confidence interval 95%)
    2.20 (1.18 to 4.30)
    2.58 (1.31 to 9.99)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was determined as the time from beginning of treatment to death from any cause. A value of "99999" represents a non-estimable number, as the study was terminated before a sufficient amount of data could be collected for accurate calculation.
    End point type
    Secondary
    End point timeframe
    Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months)
    End point values
    		 Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Number of subjects analysed
    13
    7
    Units: Months
        median (confidence interval 95%)
    7.03 (3.75 to 99999)
    99999 (1.45 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

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    End point title
    		 Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
    End point description
    Incidence, type and severity of all adverse events (AEs) and serious adverse events (SAEs), based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03).
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 18 months
    End point values
    		 Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Number of subjects analysed
    13
    7
    Units: Percentage of Participants
    number (not applicable)
        AEs
    84.6
    100
        Grade 1 AE
    7.7
    14.3
        Grade 2 AE
    23.1
    57.1
        Grade 3 AE
    30.8
    28.1
        Grade 4 AE
    0
    0
        Grade 5 AE
    23.1
    0
        AE greater than Grade 3
    53.8
    28.6
        AE related to Trastuzumab Emtansine (TE)
    84.6
    85.7
        SAEs
    46.2
    28.6
        SAE related to TE
    0
    0
        AE with fatal outcome
    23.1
    0
        AE leading to discontinuation of TE
    23.1
    0
        AE leading to modification of TE
    61.5
    57.1
        AE of special interest
    0
    0
        SAE of special interest
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria

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    End point title
    		 Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria
    End point description
    Participants from both cohorts (UBC and Pancreatic cancer/cholangiocarcinoma) were analyzed for drug-induced liver injury following Hy's Law. Hy's Law criteria for potential drug-induced liver injury includes an elevated ALT (alanine aminotransferase) or AST (aspartate aminotransferase) in combination with either elevated bilirubin or clinical jaundice.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 18 months
    End point values
    		 Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Number of subjects analysed
    13
    7
    Units: Percentage of Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Plasma/Serum Concentrations of Trastuzumab Emtansine

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    End point title
    		 Plasma/Serum Concentrations of Trastuzumab Emtansine
    End point description
    Samples for evaluation of trastuzumab emtansine, DM1, and total trastuzumab were obtained from all participants from both cohorts at specified time points. A value of "99999" represents a non-estimable number, as the study was terminated before a sufficient amount of data could be collected for accurate calculation.
    End point type
    Secondary
    End point timeframe
    Regimen A: predose (0 minutes [min]) and 15-30 min postinfusion on Days (D) 1, 8, 15 of Cycle (C) 1 and D1C4; predose on D1C2. Regimen B: predose and 15-30 min postinfusion on D1C1 and D1C4; predose on D1C2. 1 Cycle=21 days
    End point values
    		 Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Number of subjects analysed
    13
    7
    Units: ng/mL
    arithmetic mean (standard deviation)
        Predose, D1C1
    99999 ( 99999 )
    99999 ( 99999 )
        15-30 min post-infusion, D1C1
    99999 ( 99999 )
    99999 ( 99999 )
        Predose, D8C1
    99999 ( 99999 )
    99999 ( 99999 )
        15-30 min post-infusion, D1C8
    99999 ( 99999 )
    99999 ( 99999 )
        Predose, D15C1
    99999 ( 99999 )
    99999 ( 99999 )
        15-30 min post-infusion, D15C8
    99999 ( 99999 )
    99999 ( 99999 )
        Predose, D1C2
    99999 ( 99999 )
    99999 ( 99999 )
        Predose, D1C4
    99999 ( 99999 )
    99999 ( 99999 )
        15-30 min post-infusion, D1C4
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to approximately 18 months
    Adverse event reporting additional description
    An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Cohort 1 (UBC)
    Reporting group description
    		 First six participants with locally advanced (unresectable and not treatable with curative intent) or metastatic UBC initially received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).

    Reporting group title
    Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Reporting group description
    		 First six participants with metastatic pancreatic cancer/cholangiocarcinoma received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w).

    Serious adverse events
    		 Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 13 (46.15%)
    2 / 7 (28.57%)
         number of deaths (all causes)
    7
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (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
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pulmonary sepsis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (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 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device-related sepsis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 (UBC) Cohort 2 (Pancreatic cancer/cholangiocarcinoma)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 13 (84.62%)
    7 / 7 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 13 (30.77%)
    2 / 7 (28.57%)
         occurrences all number
    5
    5
    Influenza like Illness
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 7 (14.29%)
         occurrences all number
    1
    2
    Pyrexia
         subjects affected / exposed
    5 / 13 (38.46%)
    3 / 7 (42.86%)
         occurrences all number
    6
    6
    Chills
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    Malaise
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 7 (28.57%)
         occurrences all number
    1
    4
    Dyspnoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Dysphonia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Affective disorder
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 7 (14.29%)
         occurrences all number
    3
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Platelet count decreased
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 7 (28.57%)
         occurrences all number
    2
    3
    Transaminases increased
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Infusion related reaction
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Ventricular dysfunction
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Meralgia paraesthetica
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Dysgeusia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    3
    Paraesthesia
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 7 (42.86%)
         occurrences all number
    0
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 7 (14.29%)
         occurrences all number
    3
    1
    Lymphopenia
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Thrombocytopenia
         subjects affected / exposed
    3 / 13 (23.08%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Leukocytosis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Neutrophilia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Photophobia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Intestinal obstruction
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 7 (14.29%)
         occurrences all number
    2
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    4 / 7 (57.14%)
         occurrences all number
    0
    5
    Abdominal pain, upper
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Gastric ulcer
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 7 (42.86%)
         occurrences all number
    0
    4
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Dermatitis acneiform
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Cystitis noninfective
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    3 / 13 (23.08%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    Pollakiuria
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Renal failure
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Back pain
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    Bone pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 13 (7.69%)
    3 / 7 (42.86%)
         occurrences all number
    1
    4
    Diabetes mellitus
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2017
    Changes to outcome measures and eligibility criteria

    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.
    The results represent the data up to primary completion date (10 April 2018). However, due to the early termination, the study was unable to fully address its primary and secondary objectives.
    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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