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    Clinical Trial Results:
    A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 2 Study)

    Summary
    EudraCT number
    		 2014-000294-39
    Trial protocol
    		 SE   AT   DK   PT   NL   FR   IE  
    Global end of trial date
    14 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Nov 2017
    First version publication date
    02 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 18424-363
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02119663
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cut-Off, Wilmington, DE, United States, 19803
    Public contact
    Incyte Corporation Call Centre, Incyte Corporation, +44 (0)330 100 3677, globalmedinfo@incyte.com
    Scientific contact
    Incyte Corporation Call Centre, Incyte Corporation, +44 (0)330 100 3677, globalmedinfo@incyte.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
    Interim
    Date of interim/final analysis
    13 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate and compare the overall survival (OS) of subjects with advanced or metastatic adenocarcinoma of the pancreas when treated with ruxolitinib in combination with Capecitabine versus Capecitabine alone.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles of Good Clinical Practice, according to the International Conference on Harmonisation Guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2014
    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
    Mexico: 2
    Country: Number of subjects enrolled
    Chile: 5
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    United States: 50
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Ireland: 1
    Worldwide total number of subjects
    86
    EEA total number of subjects
    19
    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)
    28
    From 65 to 84 years
    56
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 51 study centers (24 in the United States [US], 4 in Austria, 4 in Israel, 3 in the Netherlands, 3 in Portugal, 2 in Argentina, 2 in Chile, 2 in Denmark, 2 in France, 2 in Mexico, 2 in Switzerland, and 1 in Ireland).

    Pre-assignment
    Screening details
    		 Subjects with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were screened for up to 28 days to determine eligibility before randomization to one of the treatment groups.

    Period 1
    Period 1 title
    Overall Trial (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
    		 Ruxolitinib plus Capecitabine
    Arm description
    		 Ruxolitinib 15 mg in combination with a starting dose of Capecitabine 2000 mg/m^2 administered orally twice daily (BID).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ruxolitinib
    Investigational medicinal product code
    Other name
    Jakafi ®, Jakavi ®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ruxolitinib 5 mg tablets administered at a dose of 15 mg twice daily (BID).

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capecitabine self-administered orally, BID, approximately 12 hours apart, for the first 14 days of each 21-day study cycle. Doses of Capecitabine administered as the appropriate number of 150 mg or 500 mg tablets.

    Arm title
    		 Placebo Plus Capecitabine
    Arm description
    		 Placebo tablets in combination with a starting dose of Capecitabine 2000 mg/m^2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets to be administered by mouth twice daily (BID).

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg or 500 mg tablets to be administered by mouth twice daily (BID).

    Number of subjects in period 1
    		Ruxolitinib plus Capecitabine Placebo Plus Capecitabine
    Started
    43
    43
    Completed
    3
    2
    Not completed
    40
    41
         Adverse event, serious fatal
    3
    2
         Physician decision
    1
    2
         Disease progression
    26
    27
         Other unspecified
    2
    -
         Adverse event, non-fatal
    5
    5
         Subject decision
    -
    1
         Study Terminated by the Sponsor
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ruxolitinib plus Capecitabine
    Reporting group description
    		 Ruxolitinib 15 mg in combination with a starting dose of Capecitabine 2000 mg/m^2 administered orally twice daily (BID).

    Reporting group title
    Placebo Plus Capecitabine
    Reporting group description
    		 Placebo tablets in combination with a starting dose of Capecitabine 2000 mg/m^2.

    Reporting group values
    		 Ruxolitinib plus Capecitabine Placebo Plus Capecitabine Total
    Number of subjects
    		 43 43 86
    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)
    		 16 12 28
        From 65-84 years
    		 26 30 56
        85 years and over
    		 1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.4 ( 10.63 ) 68.8 ( 8.43 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 21 39
        Male
    		 25 22 47

    End points

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    End points reporting groups
    Reporting group title
    Ruxolitinib plus Capecitabine
    Reporting group description
    		 Ruxolitinib 15 mg in combination with a starting dose of Capecitabine 2000 mg/m^2 administered orally twice daily (BID).

    Reporting group title
    Placebo Plus Capecitabine
    Reporting group description
    		 Placebo tablets in combination with a starting dose of Capecitabine 2000 mg/m^2.

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival is reported here based on the number of days from randomization to death or until the data cut-off.
    End point type
    Primary
    End point timeframe
    Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016.
    End point values
    		 Ruxolitinib plus Capecitabine Placebo Plus Capecitabine
    Number of subjects analysed
    43 [1]
    43 [2]
    Units: Days
        median (confidence interval 95%)
    108.0 (62.0 to 124.0)
    149.0 (84.0 to 256.0)
    Notes
    [1] - The intent-to-treat (ITT) population consisted of all participants randomized to the study.
    [2] - The intent-to-treat (ITT) population consisted of all participants randomized to the study.
    Statistical analysis title
    		 Overall Survival (OS)
    Comparison groups
    Ruxolitinib plus Capecitabine v Placebo Plus Capecitabine
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.584
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.886
         upper limit
    		 2.83

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS is defined as the number of days from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of non-target lesions.
    End point type
    Secondary
    End point timeframe
    Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
    End point values
    		 Ruxolitinib plus Capecitabine Placebo Plus Capecitabine
    Number of subjects analysed
    43 [3]
    43 [4]
    Units: Days
        median (confidence interval 95%)
    48 (37 to 83)
    61 (41 to 86)
    Notes
    [3] - ITT population
    [4] - ITT population
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    Objective response rate determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumours RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by RECIST at any post baseline visit. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions and no appearance of new lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
    End point values
    		 Ruxolitinib plus Capecitabine Placebo Plus Capecitabine
    Number of subjects analysed
    43 [5]
    43 [6]
    Units: Percentage of participants
    number (not applicable)
        Objective response
    4.7
    2.3
        Complete response
    2.3
    0
        Partial response
    2.3
    2.3
    Notes
    [5] - ITT population
    [6] - ITT population
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions and no appearance of new lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
    End point type
    Secondary
    End point timeframe
    Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
    End point values
    		 Ruxolitinib plus Capecitabine Placebo Plus Capecitabine
    Number of subjects analysed
    43 [7]
    43 [8]
    Units: Days
        median (confidence interval 95%)
    999.99 (999.99 to 999.99)
    999.99 (999.99 to 999.99)
    Notes
    [7] - DOR was not evaluable in the treatment group due to the insufficient number of subjects with events.
    [8] - DOR was not evaluable in the treatment group due to the insufficient number of subjects with events.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study medication through the double-blind period through 30 days post-study termination up to 6-months or to the data cutoff 13APR2016.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Ruxolitinib plus Capecitabine
    Reporting group description
    		 Ruxolitinib 15 mg in combination with a starting dose of Capecitabine 2000 mg/m^2 administered orally twice daily (BID).

    Reporting group title
    Placebo Plus Capecitabine
    Reporting group description
    		 Placebo tablets in combination with a starting dose of Capecitabine 2000 mg/m^2.

    Serious adverse events
    		 Ruxolitinib plus Capecitabine Placebo Plus Capecitabine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 42 (71.43%)
    21 / 43 (48.84%)
         number of deaths (all causes)
    31
    31
         number of deaths resulting from adverse events
    8
    2
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 42 (2.38%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Sudden cardiac death
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Early satiety
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (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
    Dyspnoea
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (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
    Fall
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    4 / 42 (9.52%)
    3 / 43 (6.98%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 42 (2.38%)
    4 / 43 (9.30%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal obstruction
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric stenosis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (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
    Sepsis
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 43 (6.98%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         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
    		 Ruxolitinib plus Capecitabine Placebo Plus Capecitabine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 42 (90.48%)
    41 / 43 (95.35%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    Hypotension
         subjects affected / exposed
    0 / 42 (0.00%)
    5 / 43 (11.63%)
         occurrences all number
    0
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 42 (23.81%)
    15 / 43 (34.88%)
         occurrences all number
    11
    15
    Oedema peripheral
         subjects affected / exposed
    7 / 42 (16.67%)
    8 / 43 (18.60%)
         occurrences all number
    8
    8
    Asthenia
         subjects affected / exposed
    7 / 42 (16.67%)
    4 / 43 (9.30%)
         occurrences all number
    7
    5
    Chills
         subjects affected / exposed
    4 / 42 (9.52%)
    2 / 43 (4.65%)
         occurrences all number
    4
    2
    Chest pain
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    Malaise
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Pain
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Oedema
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 43 (4.65%)
         occurrences all number
    3
    3
    Pyrexia
         subjects affected / exposed
    8 / 42 (19.05%)
    6 / 43 (13.95%)
         occurrences all number
    9
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 42 (2.38%)
    4 / 43 (9.30%)
         occurrences all number
    1
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 43 (2.33%)
         occurrences all number
    5
    1
    Depression
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Insomnia
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 43 (6.98%)
         occurrences all number
    3
    3
    Weight decreased
         subjects affected / exposed
    3 / 42 (7.14%)
    4 / 43 (9.30%)
         occurrences all number
    3
    4
    Blood creatinine increased
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    4
    Platelet count decreased
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 42 (0.00%)
    4 / 43 (9.30%)
         occurrences all number
    0
    6
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 42 (14.29%)
    4 / 43 (9.30%)
         occurrences all number
    7
    4
    Headache
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 43 (6.98%)
         occurrences all number
    2
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    17 / 42 (40.48%)
    10 / 43 (23.26%)
         occurrences all number
    18
    14
    Leukocytosis
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Leukopenia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Neutropenia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    13 / 42 (30.95%)
    4 / 43 (9.30%)
         occurrences all number
    15
    4
    Nausea
         subjects affected / exposed
    10 / 42 (23.81%)
    10 / 43 (23.26%)
         occurrences all number
    10
    12
    Vomiting
         subjects affected / exposed
    12 / 42 (28.57%)
    10 / 43 (23.26%)
         occurrences all number
    15
    10
    Diarrhoea
         subjects affected / exposed
    12 / 42 (28.57%)
    11 / 43 (25.58%)
         occurrences all number
    17
    17
    Abdominal distension
         subjects affected / exposed
    12 / 42 (28.57%)
    4 / 43 (9.30%)
         occurrences all number
    13
    4
    Constipation
         subjects affected / exposed
    9 / 42 (21.43%)
    12 / 43 (27.91%)
         occurrences all number
    10
    12
    Ascites
         subjects affected / exposed
    5 / 42 (11.90%)
    5 / 43 (11.63%)
         occurrences all number
    5
    5
    Stomatitis
         subjects affected / exposed
    6 / 42 (14.29%)
    4 / 43 (9.30%)
         occurrences all number
    6
    4
    Abdominal pain upper
         subjects affected / exposed
    6 / 42 (14.29%)
    4 / 43 (9.30%)
         occurrences all number
    7
    4
    Flatulence
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    11 / 42 (26.19%)
    11 / 43 (25.58%)
         occurrences all number
    14
    13
    Skin hyperpigmentation
         subjects affected / exposed
    4 / 42 (9.52%)
    0 / 43 (0.00%)
         occurrences all number
    6
    0
    Dry skin
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 42 (7.14%)
    7 / 43 (16.28%)
         occurrences all number
    3
    7
    Muscular weakness
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    3
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    11 / 42 (26.19%)
    12 / 43 (27.91%)
         occurrences all number
    11
    15
    Hypokalaemia
         subjects affected / exposed
    8 / 42 (19.05%)
    9 / 43 (20.93%)
         occurrences all number
    8
    11
    Dehydration
         subjects affected / exposed
    4 / 42 (9.52%)
    3 / 43 (6.98%)
         occurrences all number
    5
    3
    Hyponatraemia
         subjects affected / exposed
    5 / 42 (11.90%)
    2 / 43 (4.65%)
         occurrences all number
    5
    2
    Hyperglycaemia
         subjects affected / exposed
    3 / 42 (7.14%)
    6 / 43 (13.95%)
         occurrences all number
    3
    7
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 42 (2.38%)
    5 / 43 (11.63%)
         occurrences all number
    1
    5
    Hypophosphataemia
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Sep 2014
    The primary purpose of the amendment was to clarify eligibility criteria and the capecitabine treatment regimen to require that only 500 mg Capecitabine tablets be dispensed because of intersubject dose variability concerns associated with administering 2 different tablet strengths (150 mg and 500 mg).
    25 Jan 2016
    The primary purpose of the amendment was to address the Medicines and Healthcare products Regulatory Agency (MHRA) 19 JAN 2016 Grounds for Non Acceptance.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Feb 2016
    The study was terminated prior to the final analysis at the recommendation of the Data Monitoring Committee based on the review of efficacy in the 18424-362 (JANUS 1).
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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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