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    Clinical Trial Results:
    A Randomized, Phase 2 Study of INCB039110 or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2013-004812-24
    Trial protocol
    		 IE   IT   DE   ES   HU  
    Global end of trial date
    05 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Sep 2017
    First version publication date
    28 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 39110-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02257619
    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
    05 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate the safety and tolerability of itacitinib in combination with docetaxel and to select doses for further evaluation (Part 1, safety run-in portion), and to evaluate and compare the overall survival of subjects with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel alone (Part 2, randomized portion). The secondary objectives of this study (Part 2) were to evaluate and compare the efficacy of the 2 treatment groups with respect to progression-free survival, overall tumor response, and duration of response, and to evaluate and compare disease control, safety, and tolerability of itacitinib in combination with docetaxel versus docetaxel alone. Part 2 of the study was not conducted.
    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
    24 Sep 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    Spain: 2
    Worldwide total number of subjects
    9
    EEA total number of subjects
    2
    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)
    4
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study enrolled subjects in 7 study centers: 6 in the United States and 1 in Spain.

    Pre-assignment
    Screening details
    		 Duration of treatment for an individual subject was expected to average approximately 5 months: up to 28 days for screening and baseline, followed by 3-week and up to 5 weeks for safety follow-up.

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

    Arms
    Arm title
    		 itacitinib plus docetaxel
    Arm description
    		 itacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m^2 once every 3 weeks (q3w) administered intravenously
    Arm type
    		 Experimental

    Investigational medicinal product name
    itacitinib
    Investigational medicinal product code
    Other name
    INCB039110
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.

    Investigational medicinal product name
    docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered as an intravenous infusion in the clinic at 75 mg/m^2 Q3W for Part 1 of the study.

    Number of subjects in period 1
    		itacitinib plus docetaxel
    Started
    9
    Completed
    0
    Not completed
    9
         Disease progression
    6
         Adverse event, non-fatal
    2
         Subject decision
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    itacitinib plus docetaxel
    Reporting group description
    		 itacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m^2 once every 3 weeks (q3w) administered intravenously

    Reporting group values
    		 itacitinib plus docetaxel Total
    Number of subjects
    		 9 9
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.1 ± 7.17 -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    itacitinib plus docetaxel
    Reporting group description
    		 itacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m^2 once every 3 weeks (q3w) administered intravenously

    Primary: Number of Participants With Dose Limiting Toxicities (DLTs)

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    End point title
    		 Number of Participants With Dose Limiting Toxicities (DLTs) [1]
    End point description
    Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD).
    End point type
    Primary
    End point timeframe
    Baseline through 21 days; the end of cycle 1.
    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 have been performed for this primary end point.
    End point values
    		 itacitinib plus docetaxel
    Number of subjects analysed
    9
    Units: participants
        number (not applicable)
    0
    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 05 APR 2016.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    itacitinib plus docetaxel
    Reporting group description
    		 itacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m^2 once every 3 weeks (q3w) administered intravenously

    Serious adverse events
    		 itacitinib plus docetaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 9 (22.22%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial tachycardia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 itacitinib plus docetaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    9
    Fatigue
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    5
    Oedema peripheral
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Vaginal inflammation
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    4
    Haemoptysis
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    4
    Oropharyngeal pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Sinus congestion
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Hallucination
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Irritability
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Weight decreased
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    White blood cell count decreased
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 9 (33.33%)
         occurrences all number
    11
    Febrile neutropenia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    9
    Dyspepsia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    5
    Oesophagitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Haematuria
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Renal failure acute
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Bone pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Muscular weakness
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Pneumonia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    5
    Dehydration
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Hypokalaemia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Vitamin D deficiency
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Feb 2014
    The primary purpose of the amendment was to change the itacitinib tablet sustained release (SR) formulation to be administered during the study. The clinically important changes included: • Administration of a 100 mg SR tablet instead of 200 or 300 mg tablets as stated in Section 10.1 of the original Protocol.
    04 Aug 2014
    The primary purpose of the amendment was to clarify the study design and reduce the number of planned cohorts and subjects within the study. The clinically important changes included: • Number of cohorts reduced from 3 and 4 in Regimens A and B, respectively (Part 1) to 2 cohorts per regimen. • 600 mg QD dose removed. • Subjects with a known sensitivity to any of the active substances or excipients excluded.
    29 Aug 2014
    The primary purpose of the amendment was to revise inclusion and exclusion criteria to provide flexibility for recruitment. The clinically important changes included: • Exclusion criterion of prior taxane use was removed and replaced with prior docetaxel use only. • Measurable lesions caveat regarding the field of prior radiation and 4-week timeframe between treatment and progression was removed. • Corticosteroid use added to allow subjects with known and stable central nervous system metastases eligibility for the study. • Mandatory withdrawal of subjects who must increase their corticosteroid use. • Aspartate transaminase/alanine transaminase and alkaline phosphatase criterion amended to match docetaxel prescriber’s information.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 May 2015
    The sponsor elected to terminate the study and not open enrollment to Part 2 due to slow enrollment into Part 1 and ongoing competing trials in similar subject populations. Subjects in Part 1 were allowed to continue receiving study treatment and were followed until discontinuation criteria were met.
    -

    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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