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    Clinical Trial Results:
    A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous Non–Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent

    Summary
    EudraCT number
    		 2014-001436-10
    Trial protocol
    		 IT   DK   ES   NL   PT  
    Global end of trial date
    21 Jun 2016

    Results information
    Results version number
    		 v3(current)
    This version publication date
    09 Nov 2017
    First version publication date
    10 Aug 2017
    Other versions
    		 v1 , v2
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    Additional information received for safety data to be added.

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 18424-266
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02119650
    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, Incyte Corporation Call Centre, +44 (0)330 100 3677, globalmedinfo@incyte.com
    Scientific contact
    Incyte Corporation, Incyte Corporation Call Centre, +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
    Final
    Date of interim/final analysis
    21 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    •Part 1: To evaluate the safety and tolerability of ruxolitinib in combination with pemetrexed/cisplatin and select a dose for further evaluation •Part 2: To evaluate and compare the OS of subjects with nonsquamous NSCLC that is Stage IIIB, Stage IV, or recurrent when treated with ruxolitinib or placebo in combination with pemetrexed/cisplatin and subsequently pemetrexed maintenance
    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
    11 Feb 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
    Netherlands: 2
    Country: Number of subjects enrolled
    Portugal: 4
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    Denmark: 6
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    United States: 31
    Worldwide total number of subjects
    76
    EEA total number of subjects
    45
    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)
    49
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 42 study centers (25 in the United States, 4 in Spain, 3 in France, 3 in Portugal, 2 in Denmark, 2 in Germany, 2 in Italy, 1 in the Netherlands).

    Pre-assignment
    Screening details
    		 Randomized, Double-Blind Portion: Anticipated duration of treatment for an individual subject was approximately 8 months: up to 28 days for screening and baseline.

    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
    		 Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin
    Arm description
    		 Ruxolitinib was self-administered as a 15 mg twice daily (BID) oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
    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
    5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID)).

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Alimta®
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m^2 administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75 mg/m^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion.

    Arm title
    		 Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Arm description
    		 Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
    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
    5 mg matching placebo tablets to be administered by mouth.

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Alimta®
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m^2 administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75 mg/m^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion.

    Number of subjects in period 1
    		Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Started
    39
    37
    Completed
    14
    11
    Not completed
    25
    26
         Multiple reasons for termination
    2
    1
         Physician decision
    -
    2
         Disease progression
    11
    14
         Adverse event, non-fatal
    3
    4
         Subject decision
    2
    3
         Death
    5
    1
         Noncompliance with study treatment
    1
    1
         Study terminated by the sponsor
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin
    Reporting group description
    		 Ruxolitinib was self-administered as a 15 mg twice daily (BID) oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).

    Reporting group title
    Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Reporting group description
    		 Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).

    Reporting group values
    		 Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin Total
    Number of subjects
    		 39 37 76
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 26 23 49
        From 65-84 years
    		 13 14 27
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.6 ( 8.85 ) 62 ( 8.55 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 14 29
        Male
    		 24 23 47
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 27.67 ( 6.402 ) 27.65 ( 7.26 ) -

    End points

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    End points reporting groups
    Reporting group title
    Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin
    Reporting group description
    		 Ruxolitinib was self-administered as a 15 mg twice daily (BID) oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).

    Reporting group title
    Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Reporting group description
    		 Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis were censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.
    End point type
    Primary
    End point timeframe
    Randomization until death due to any cause; up to 16 months or data cutoff 11FEB2016.
    End point values
    		 Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Number of subjects analysed
    39 [1]
    37 [2]
    Units: months
        median (confidence interval 80%)
    7.5 (5.7 to 999.99)
    5.9 (4 to 999.99)
    Notes
    [1] - (ITT) population. 999.99= Not evaluable due to insufficient number of participants with events.
    [2] - (ITT) population. 999.99= Not evaluable due to insufficient number of participants with events.
    Statistical analysis title
    		 Overall Survival
    Comparison groups
    Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin v Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7562 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.877
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.509
         upper limit
    		 1.51
    Notes
    [3] - The 2-sided p-value was calculated based on the log-rank test and stratified by modified Glasgow Prognostic Score (mGPS).

    Secondary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS)
    End point description
    PFS is defined as the time 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, unequivocal progression of non-target lesions or increase in disease burden for subjects with only nonmeasurable disease.
    End point type
    Secondary
    End point timeframe
    Randomization to disease progression, or death due to any cause if sooner; up to 16 months or to the data cutoff 11FEB2016.
    End point values
    		 Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Number of subjects analysed
    39 [4]
    37 [5]
    Units: months
        number (not applicable)
    0
    0
    Notes
    [4] - PFS was not conducted due to early termination and insufficient number of participants with events.
    [5] - PFS was not conducted due to early termination and insufficient number of participants with events.
    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 RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (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; 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 16 months or to the data cutoff 11FEB2016.
    End point values
    		 Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Number of subjects analysed
    39 [6]
    37 [7]
    Units: participants
    number (not applicable)
        Overall Response
    12
    13
        Complete Response
    0
    0
        Partial Response
    12
    13
        Stable Disease
    4
    5
        Progressive Disease
    6
    4
        Unable to Evaluate
    2
    3
        Not Assessed
    15
    12
    Notes
    [6] - The intent-to-treat (ITT) population consisted of participants that were randomized in the study.
    [7] - The intent-to-treat (ITT) population consisted of participants that were randomized in the study.
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    For objective responders, the duration of response is defined as the difference of the end of response and the start of response. The start of a response was the first visit where the subject achieves PR or better based on RECIST v1.1 criteria. The end of response was the first visit after PD based on RECIST v1.1 criteria.
    End point type
    Secondary
    End point timeframe
    From the start of response to the end of response; up to 16 months or to the data cutoff 11FEB2016.
    End point values
    		 Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Number of subjects analysed
    12 [8]
    13 [9]
    Units: weeks
        median (confidence interval 80%)
    20.14 (18 to 30.71)
    12.14 (6 to 24)
    Notes
    [8] - The intent-to-treat (ITT) population consisted of participants that were randomized in the study.
    [9] - The intent-to-treat (ITT) population consisted of participants that were randomized in the study.
    No statistical analyses for this end point

    Secondary: Participants With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Participants With Treatment-emergent Adverse Events (TEAEs)
    End point description
    A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
    End point type
    Secondary
    End point timeframe
    Baseline through approximately 30 days post treatment discontinuation; up to 16 months or to the data cutoff 11FEB2016.
    End point values
    		 Double-Blind Treatment: Ruxolitinib plus Pemetrexed/Cisplatin Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Number of subjects analysed
    39 [10]
    37 [11]
    Units: participants
    number (not applicable)
        Participants who had any TEAEs
    39
    36
        Participants who had treatment-related TEAEs
    16
    28
        Participants with any serious TEAE
    19
    16
        Participants who had Grade 3 or higher TEAEs
    25
    22
        Participants with a fatal TEAE
    4
    4
        TEAEs related to reference therapy
    30
    35
        Participants who were hospitalized due to TEAEs
    16
    15
        Participants who discontinued drug due to TEAEs
    2
    4
        Participants who interrupted drug due to TEAEs
    11
    15
        Discontinued reference therapy due to TEAEs
    4
    7
        Interrupted reference therapy due to TEAEs
    8
    7
        Participants given concomitant meds due to TEAEs
    36
    32
        Procedure/nondrug therapy due to TEAEs
    17
    12
    Notes
    [10] - Safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
    [11] - Safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
    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 approximately 30 days post treatment discontinuation; up to 16 months or to the data cutoff 11FEB2016.
    Adverse event reporting additional description
    The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin
    Reporting group description
    		 Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).

    Reporting group title
    Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Reporting group description
    		 Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).

    Serious adverse events
    		 Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 39 (48.72%)
    16 / 37 (43.24%)
         number of deaths (all causes)
    4
    4
         number of deaths resulting from adverse events
    4
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (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 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pleuritic pain
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary toxicity
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         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 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Chemical peritonitis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve disorder
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (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
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis acute
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis acute
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (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
    Pneumonia
         subjects affected / exposed
    3 / 39 (7.69%)
    3 / 37 (8.11%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Septic shock
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (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
    1 / 39 (2.56%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to thrive
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 39 (94.87%)
    36 / 37 (97.30%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 37 (5.41%)
         occurrences all number
    3
    3
    Fatigue
         subjects affected / exposed
    13 / 39 (33.33%)
    14 / 37 (37.84%)
         occurrences all number
    15
    14
    Oedema peripheral
         subjects affected / exposed
    8 / 39 (20.51%)
    5 / 37 (13.51%)
         occurrences all number
    8
    5
    Pyrexia
         subjects affected / exposed
    7 / 39 (17.95%)
    4 / 37 (10.81%)
         occurrences all number
    7
    5
    Asthenia
         subjects affected / exposed
    7 / 39 (17.95%)
    12 / 37 (32.43%)
         occurrences all number
    9
    17
    Malaise
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Cough
         subjects affected / exposed
    6 / 39 (15.38%)
    9 / 37 (24.32%)
         occurrences all number
    6
    11
    Dyspnoea
         subjects affected / exposed
    7 / 39 (17.95%)
    9 / 37 (24.32%)
         occurrences all number
    8
    16
    Dyspnoea exertional
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 37 (2.70%)
         occurrences all number
    3
    1
    Nasal congestion
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Epistaxis
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Haemoptysis
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    0
    3
    Productive cough
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Wheezing
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Depression
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    2
    2
    Insomnia
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 37 (8.11%)
         occurrences all number
    2
    3
    Investigations
    Blood calcium decreased
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Blood creatinine increased
         subjects affected / exposed
    4 / 39 (10.26%)
    2 / 37 (5.41%)
         occurrences all number
    5
    2
    Weight decreased
         subjects affected / exposed
    4 / 39 (10.26%)
    3 / 37 (8.11%)
         occurrences all number
    4
    3
    C-reactive protein increased
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    1
    3
    Platelet count decreased
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    1
    3
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 39 (5.13%)
    6 / 37 (16.22%)
         occurrences all number
    2
    7
    Dysgeusia
         subjects affected / exposed
    2 / 39 (5.13%)
    6 / 37 (16.22%)
         occurrences all number
    3
    6
    Headache
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 37 (5.41%)
         occurrences all number
    5
    2
    Neuropathy peripheral
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 37 (0.00%)
         occurrences all number
    4
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    3
    4
    Syncope
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    4
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    15 / 39 (38.46%)
    12 / 37 (32.43%)
         occurrences all number
    23
    15
    Neutropenia
         subjects affected / exposed
    8 / 39 (20.51%)
    4 / 37 (10.81%)
         occurrences all number
    15
    6
    Thrombocytopenia
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 37 (0.00%)
         occurrences all number
    5
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 37 (10.81%)
         occurrences all number
    1
    4
    Ototoxicity
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 37 (10.81%)
         occurrences all number
    1
    5
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    2
    2
    Constipation
         subjects affected / exposed
    13 / 39 (33.33%)
    13 / 37 (35.14%)
         occurrences all number
    14
    15
    Diarrhoea
         subjects affected / exposed
    9 / 39 (23.08%)
    10 / 37 (27.03%)
         occurrences all number
    9
    12
    Dyspepsia
         subjects affected / exposed
    0 / 39 (0.00%)
    4 / 37 (10.81%)
         occurrences all number
    0
    5
    Dysphagia
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 37 (5.41%)
         occurrences all number
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    20 / 39 (51.28%)
    32 / 37 (86.49%)
         occurrences all number
    25
    48
    Stomatitis
         subjects affected / exposed
    10 / 39 (25.64%)
    7 / 37 (18.92%)
         occurrences all number
    12
    11
    Vomiting
         subjects affected / exposed
    7 / 39 (17.95%)
    12 / 37 (32.43%)
         occurrences all number
    11
    18
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Rash
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 37 (10.81%)
         occurrences all number
    1
    4
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Back pain
         subjects affected / exposed
    4 / 39 (10.26%)
    4 / 37 (10.81%)
         occurrences all number
    5
    4
    Muscular weakness
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    2
    2
    Musculoskeletal pain
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Myalgia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Neck pain
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    0
    3
    Pain in extremity
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Candida infection
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Pneumonia
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Rhinitis
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 37 (2.70%)
         occurrences all number
    3
    1
    Bronchitis
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 37 (8.11%)
         occurrences all number
    1
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 39 (12.82%)
    14 / 37 (37.84%)
         occurrences all number
    7
    14
    Dehydration
         subjects affected / exposed
    4 / 39 (10.26%)
    2 / 37 (5.41%)
         occurrences all number
    5
    2
    Hypokalaemia
         subjects affected / exposed
    3 / 39 (7.69%)
    7 / 37 (18.92%)
         occurrences all number
    3
    7
    Hyponatraemia
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 37 (8.11%)
         occurrences all number
    3
    3
    Hyperglycaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    3
    Hyperkalaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Hypomagnesaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    6 / 37 (16.22%)
         occurrences all number
    3
    10
    Hypophosphataemia
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jan 2014
    The primary purpose of the amendment was to clarify the designation of study visits: Cycles where both pemetrexed and cisplatin were given were designated TCycles. Cycles where maintenance pemetrexed was given were designated MCycles. Ruxolitinib or placebo were given during both TCycles and MCycles
    01 Jul 2014
    The primary purpose of the amendment was to revise requirements regarding prior treatments and to clarify language referring to pleural/pericardial effusion. The clinically important changes included: • Revision of the requirement for wash-out for prior treatments of central nervous system metastases • Removal of language referring to pleural/pericardial effusion as a descriptor for Stage IIIB NCSLC.
    10 Sep 2014
    The primary purpose of the amendment was to add or clarify several items. The clinically important changes included: • Addition of an additional exclusion criteria of prior JAK inhibitor use • Addition of a risks summary for granulocyte colony-stimulating factor (GCSF) • Addition of additional information on the DMC • Update to information regarding contraceptive use • Addition of a listing of inducers of CYP 3A4.
    02 Feb 2015
    The primary purpose of the amendment was to add or clarify several items. The clinically important changes included: • Addition of a brief summary of Part 1 and to designate the dose for Part 2 as 15 mg BID ruxolitinib/matching placebo, without prophylactic GCSF in a randomized, double-blind comparison • Removal of language describing prophylactic GCSF use and the possibility for open label study for clarity • Addition of a prescreening C-reactive protein measurement and an optional tissue biopsy for consenting subjects • Update to contraceptive language • Addition of options for administration of vitamin B12 • Addition of options for use of dexamethasone as both an anti-inflammatory and anti emetic prophylaxis.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    11 Feb 2016
    The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation.
    -

    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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