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    Clinical Trial Results:
    An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated with the Investigational PI3Kδ Inhibitor, GS-9820

    Summary
    EudraCT number
    		 2015-005766-39
    Trial protocol
    		 NL  
    Global end of trial date
    28 Dec 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    31 Jan 2019
    First version publication date
    02 Jan 2019
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Updating that the study was terminated and removing Race/Ethnicity as data was not collected.

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-313-2120
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02739360
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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
    28 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to provide idelalisib to participants receiving GS-9820 in study GS-US-315-0102 at the time of study closure.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 May 2016
    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
    Netherlands: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    0
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the Netherlands. The first participant was screened on 04 May 2016. The last study visit occurred on 28 December 2017.

    Pre-assignment
    Screening details
    		 Six participants previously enrolled in Study GS-US-315-0102 were offered screening for enrollment into this study.

    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
    Arm title
    		 Idelalisib
    Arm description
    		 Idelalisib administered orally twice daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Idelalisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Idelalisib 150 mg tablet administered orally twice daily.

    Number of subjects in period 1
    		Idelalisib
    Started
    3
    Completed
    0
    Not completed
    3
         Study terminated by Sponsor
    2
         Adverse Event
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Idelalisib
    Reporting group description
    		 Idelalisib administered orally twice daily.

    Reporting group values
    		 Idelalisib Total
    Number of subjects
    		 3 3
    Age categorical
    Units: Subjects
        From 65-84 years
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Idelalisib
    Reporting group description
    		 Idelalisib administered orally twice daily.

    Primary: Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths

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    End point title
    		 Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths [1]
    End point description
    The severity of Adverse Events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. An SAE was defined as an event that, at any dose, resulted in one or more of the following: 1) Death, 2) Life-threatening, 3) In-patient hospitalization or prolongation of existing hospitalization, 4) Persistent or significant disability/incapacity, 5) A congenital anomaly/birth defect, or 6) A medically important event or reaction. Safety Analysis Set included participants who took at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to Day 602 plus 30 days
    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 comparison was planned or performed.
    End point values
    		 Idelalisib
    Number of subjects analysed
    3
    Units: Participants
        ≥ Grade 3 Adverse Event
    1
        SAE
    1
        Death
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 602 plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set included participants who took at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Idelalisib
    Reporting group description
    		 Idelalisib 150 mg tablet administered orally twice daily.

    Serious adverse events
    		 Idelalisib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Hepatobiliary disorders
    Cholangitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lung disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Idelalisib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Vascular disorders
    Intermittent claudication
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Influenza like illness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Oedema peripheral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Bronchitis chronic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Psychiatric disorders
    Delirium
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Investigations
    Aspartate aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Neuralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Eye disorders
    Vision blurred
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal distension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Dry mouth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Skin ulcer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Renal impairment
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Infections and infestations
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 3 (100.00%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Mar 2016
    Updates to the safety information and guidelines for toxicity management to be consistent across idelalisib study protocols. These changes include mandated prophylaxis for PJP, CMV surveillance and increased monitoring.
    26 Aug 2016
    Dose modification updates, PJP prophylaxis update.
    04 Nov 2016
    Revised language around idelalisib administration in the event of pneumonitis.

    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
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    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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