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    Clinical Trial Results:
    A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non–Small Cell Lung Cancer and Stage IV Microsatellite-Stable Colorectal Cancer

    Summary
    EudraCT number
    		 2016-004289-25
    Trial protocol
    		 GB   ES  
    Global end of trial date
    02 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Mar 2021
    First version publication date
    18 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 24360-206
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cut-Off, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation Call Centre, +800 00027423, globalmedinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation Call Centre, +800 00027423, 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
    02 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the safety, tolerability, and efficacy of Azacitidine in combination with Pembrolizumab and Epacadostat in subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non–Small Cell Lung Cancer and Stage IV Microsatellite-Stable Colorectal Cancer.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Feb 2017
    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
    United States: 63
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Spain: 1
    Worldwide total number of subjects
    70
    EEA total number of subjects
    1
    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)
    51
    From 65 to 84 years
    19
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 8 study sites in United States, 2 sites in UK and 1 site in Spain.

    Pre-assignment
    Screening details
    		 A total of 70 participants were enrolled in the study. Study enrollment was permanently discontinued on 15-Feb-2019 as a strategic decision. No patients were enrolled in Treatment Group B and Treatment Group C.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Group A :100mg of INCB24360
    Arm description
    		 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
    Arm type
    		 Experimental

    Investigational medicinal product name
    azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Infusion
    Routes of administration
    Subcutaneous use, Intravenous use
    Dosage and administration details
    Intravenous Injection

    Investigational medicinal product name
    Epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Orally twice daily

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous Injection

    Arm title
    		 Treatment Group A :300mg of INCB24360
    Arm description
    		 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Infusion
    Routes of administration
    Subcutaneous use, Intravenous use
    Dosage and administration details
    Intravenous Injection

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous Injection

    Investigational medicinal product name
    Epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Orally twice daily

    Number of subjects in period 1
    		Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360
    Started
    62
    8
    Completed
    0
    0
    Not completed
    62
    8
         Adverse event, serious fatal
    33
    3
         Consent withdrawn by subject
    11
    3
         Progressive Disease
    9
    1
         Study Terminated by Sponsor
    2
    -
         Lost to follow-up
    3
    1
         Other Unspecified
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Group A :100mg of INCB24360
    Reporting group description
    		 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.

    Reporting group title
    Treatment Group A :300mg of INCB24360
    Reporting group description
    		 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.

    Reporting group values
    		 Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360 Total
    Number of subjects
    		 62 8 70
    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)
    		 45 6 51
        From 65-84 years
    		 17 2 19
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.0 ± 11.92 53.0 ± 11.31 -
    Sex: Female, Male
    Units:
        Female
    		 19 4 23
        Male
    		 43 4 47
    Race/Ethnicity, Customized
    Units: Subjects
        White/Caucasian
    		 56 5 61
        Black/African-American
    		 3 0 3
        Asian
    		 2 0 2
        American-Indian/Alaska Native
    		 0 0 0
        Native Hawaiian/Pacific Islander
    		 0 0 0
        Other
    		 1 3 4
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 4 2 6
        Not Hispanic or Latino
    		 54 6 60
        Unknown
    		 4 0 4

    End points

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    End points reporting groups
    Reporting group title
    Treatment Group A :100mg of INCB24360
    Reporting group description
    		 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.

    Reporting group title
    Treatment Group A :300mg of INCB24360
    Reporting group description
    		 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.

    Subject analysis set title
    Treatment Group A :100 or 300mg of INCB24360
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment Group A :100mg of INCB24360 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg or 300mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.

    Primary: Part 1 and 2 : Frequency, duration, and severity of adverse events

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    End point title
    		 Part 1 and 2 : Frequency, duration, and severity of adverse events [1]
    End point description
    A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. 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
    Primary
    End point timeframe
    Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point
    End point values
    		 Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360
    Number of subjects analysed
    62
    8
    Units: participants
    62
    8
    No statistical analyses for this end point

    Primary: Part 1 and 2: Objective response rate based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

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    End point title
    		 Part 1 and 2: Objective response rate based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [2]
    End point description
    ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A participant was considered as an objective responder if the participant had a best overall response of CR or PR.
    End point type
    Primary
    End point timeframe
    Every 9 weeks for the duration of study participation; estimated minimum of 6 months.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point
    End point values
    		 Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360
    Number of subjects analysed
    62
    8
    Units: participants
    3
    1
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of responders determined by immunohistochemistry

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    End point title
    		 Parts 1 and 2: Percentage of responders determined by immunohistochemistry
    End point description
    Responder is defined as an increase in the number of tumor-infiltrating lymphocytes or the ratio of CD8+ lymphocytes to T regulatory cells infiltrating tumor post-treatment versus pretreatment with pembrolizumab and epacadostat in combination with azacitidine.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 5/6 or week 8/9
    End point values
    		 Treatment Group A :100 or 300mg of INCB24360
    Number of subjects analysed
    19
    Units: participants
        Intratumoral CD8+ T cells
    14
        CD8+:FoxP3+ ratios
    10
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Progression-free survival based on RECIST v1.1.

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    End point title
    		 Parts 1 and 2: Progression-free survival based on RECIST v1.1.
    End point description
    Defined as the time from date of first dose of study drug until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
    End point type
    Secondary
    End point timeframe
    Every 9 weeks for the duration of study participation; estimated minimum of 6 months.
    End point values
    		 Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360
    Number of subjects analysed
    62
    8
    Units: Months
        median (confidence interval 95%)
    2.07 (1.97 to 2.17)
    2.64 (1.31 to 6.11)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Duration of response based on RECIST v1.1

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    End point title
    		 Parts 1 and 2: Duration of response based on RECIST v1.1
    End point description
    Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
    End point type
    Secondary
    End point timeframe
    Every 9 weeks for the duration of study participation; estimated minimum of 6 months.
    End point values
    		 Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360
    Number of subjects analysed
    3
    1 [3]
    Units: Months
        median (confidence interval 95%)
    2.63 (2.20 to 21.85)
    1.22 (-99.99 to 99.99)
    Notes
    [3] - Upper and lower limits are not estimablle
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study start up to clinical data cut-off date of 15 Feb 2019 (approximately 21 months)
    Adverse event reporting additional description
    The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups Band C.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 19.1
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Treatment Group A :300mg of INCB24360
    Reporting group description
    		 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.

    Reporting group title
    Treatment Group A :100mg of INCB24360
    Reporting group description
    		 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.

    Serious adverse events
    		 Treatment Group A :300mg of INCB24360 Treatment Group A :100mg of INCB24360
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 8 (37.50%)
    28 / 62 (45.16%)
         number of deaths (all causes)
    4
    41
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant Neoplasm Progression
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal Cancer Metastatic
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphangiosis Carcinomatosa
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Disease Progression
         subjects affected / exposed
    0 / 8 (0.00%)
    8 / 62 (12.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 7
    Asthenia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac Chest Pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head Injury
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinua tachycardia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain Injury
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain Oedema
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dizziness
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysmetria
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peroneal Nerve Palsy
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of Consciousness
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 62 (4.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 62 (6.45%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 62 (3.23%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary Retention
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 62 (4.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         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
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (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
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         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
    0 / 8 (0.00%)
    1 / 62 (1.61%)
         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
    		 Treatment Group A :300mg of INCB24360 Treatment Group A :100mg of INCB24360
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    59 / 62 (95.16%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 62 (3.23%)
         occurrences all number
    2
    2
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 62 (6.45%)
         occurrences all number
    1
    4
    Fatigue
         subjects affected / exposed
    6 / 8 (75.00%)
    28 / 62 (45.16%)
         occurrences all number
    7
    28
    Injection site erythema
         subjects affected / exposed
    0 / 8 (0.00%)
    5 / 62 (8.06%)
         occurrences all number
    0
    5
    Injection site pain
         subjects affected / exposed
    0 / 8 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    0
    4
    Injection site reaction
         subjects affected / exposed
    0 / 8 (0.00%)
    13 / 62 (20.97%)
         occurrences all number
    0
    13
    Local swelling
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 8 (0.00%)
    6 / 62 (9.68%)
         occurrences all number
    0
    7
    Oedema peripheral
         subjects affected / exposed
    1 / 8 (12.50%)
    6 / 62 (9.68%)
         occurrences all number
    1
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 8 (25.00%)
    9 / 62 (14.52%)
         occurrences all number
    2
    9
    Dyspnoea
         subjects affected / exposed
    1 / 8 (12.50%)
    8 / 62 (12.90%)
         occurrences all number
    1
    8
    Dyspnoea exertional
         subjects affected / exposed
    0 / 8 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    0
    4
    Productive cough
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 62 (3.23%)
         occurrences all number
    2
    2
    Wheezing
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 8 (12.50%)
    5 / 62 (8.06%)
         occurrences all number
    1
    5
    Anxiety
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 62 (4.84%)
         occurrences all number
    1
    3
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 8 (25.00%)
    4 / 62 (6.45%)
         occurrences all number
    2
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 8 (37.50%)
    5 / 62 (8.06%)
         occurrences all number
    3
    7
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 8 (25.00%)
    7 / 62 (11.29%)
         occurrences all number
    2
    7
    Blood creatinine increased
         subjects affected / exposed
    0 / 8 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    0
    4
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    White blood cell count decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 62 (4.84%)
         occurrences all number
    1
    3
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Sinus Tachycardia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 8 (50.00%)
    4 / 62 (6.45%)
         occurrences all number
    4
    4
    Neuropathy peripheral
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    Peroneal nerve palsy
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 8 (25.00%)
    11 / 62 (17.74%)
         occurrences all number
    2
    15
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 62 (3.23%)
         occurrences all number
    2
    2
    Abdominal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    12 / 62 (19.35%)
         occurrences all number
    1
    15
    Constipation
         subjects affected / exposed
    3 / 8 (37.50%)
    16 / 62 (25.81%)
         occurrences all number
    3
    18
    Abdominal pain lower
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 62 (4.84%)
         occurrences all number
    1
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 62 (6.45%)
         occurrences all number
    1
    4
    Nausea
         subjects affected / exposed
    3 / 8 (37.50%)
    34 / 62 (54.84%)
         occurrences all number
    3
    38
    Vomiting
         subjects affected / exposed
    2 / 8 (25.00%)
    21 / 62 (33.87%)
         occurrences all number
    3
    26
    Diarrhoea
         subjects affected / exposed
    3 / 8 (37.50%)
    12 / 62 (19.35%)
         occurrences all number
    3
    14
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Dermatitis acneiform
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 8 (12.50%)
    6 / 62 (9.68%)
         occurrences all number
    1
    6
    Rash
         subjects affected / exposed
    2 / 8 (25.00%)
    9 / 62 (14.52%)
         occurrences all number
    2
    10
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Pneumaturia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Terminal dribbling
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    7 / 62 (11.29%)
         occurrences all number
    1
    7
    Back pain
         subjects affected / exposed
    2 / 8 (25.00%)
    6 / 62 (9.68%)
         occurrences all number
    2
    7
    Flank pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    Musculoskeletal pain
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    2 / 8 (25.00%)
    4 / 62 (6.45%)
         occurrences all number
    2
    4
    Neck pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Mastoiditis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 62 (4.84%)
         occurrences all number
    1
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 8 (62.50%)
    12 / 62 (19.35%)
         occurrences all number
    5
    12
    Hypercalcaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    0
    4
    Hypomagnesaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    0
    4
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 62 (6.45%)
         occurrences all number
    1
    4
    Hyponatraemia
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 62 (4.84%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2016
    The primary purpose of this amendment is to address FDA's October 20, 2016, clinical information request.
    02 Jun 2017
    The primary purpose of this amendment is to extend the length of azacitidine treatment and add new expansion cohorts to evaluate different sequences of treatment for the 3 study drugs.
    20 Oct 2017
    The primary purpose of this amendment is to add 2 additional treatment groups, which include regimens with INCB057643 and INCB059872.
    30 Aug 2018
    specify that scans to confirm disease progression should be conducted at least 4 weeks and no later than 8 weeks from the initial scans showing PD

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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