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    Clinical Trial Results:
    A Phase 2 Study of the Safety and Anti-tumor Activity of the Oral Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Patients with Initial or Refractory/Relapsed Richter's Transformation

    Summary
    EudraCT number
    		 2014-001240-38
    Trial protocol
    		 ES   DE   GB  
    Global end of trial date
    31 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2021
    First version publication date
    20 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KCP-330-010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02138786
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karyopharm Therapeutics, Inc.
    Sponsor organisation address
    85 Wells Avenue, Newton, MA, United States, 02459
    Public contact
    Clinical Trial Information Desk, Karyopharm Therapeutics, Inc., clinicaltrials@karyopharm.com
    Scientific contact
    Clinical Trial Information Desk, Karyopharm Therapeutics, Inc., clinicaltrials@karyopharm.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
    31 Aug 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the overall response rate (ORR), including partial response (PR) and complete response (CR), as well as the duration of response (DOR).
    Protection of trial subjects
    This study was monitored in accordance with the Sponsor’s procedures, which meet the ICH Harmonised Tripartite Guidelines for GCP, with applicable local regulations, and with the ethical principles outlined in the Declaration of Helsinki.
    Background therapy
    		 Palliative radiation therapy to non-target lesions was permitted.
    Evidence for comparator
    		 No comparator used
    Actual start date of recruitment
    14 Nov 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
    Poland: 3
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    26
    EEA total number of subjects
    16
    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)
    6
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 15 sites in the United States and Europe between November 2014 and July 2016.

    Pre-assignment
    Screening details
    		 A total of 27 subjects were enrolled out of which 1 subjects discontinued the study before the start of the treatment. Out of which 26 subjects started the study treatment.

    Period 1
    Period 1 title
    Baseline (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
    		 Selinexor 60 mg/m^2 (8 Doses/Cycle)
    Arm description
    		 Subjects received a dose of 60 milligrams/square meter (mg/m^2) of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-4 (8 doses/cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selinexor
    Investigational medicinal product code
    KPT-330
    Other name
    XPOVIO, NEXPOVIO
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg and 50 mg coated, immediate-release tablets taken orally.

    Arm title
    		 Selinexor 60 mg (6 doses/cycle)
    Arm description
    		 Subjects received a dose of 60 milligrams (mg) of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-3 (6 doses/cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selinexor
    Investigational medicinal product code
    KPT-330
    Other name
    XPOVIO, NEXPOVIO
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg and 50 mg coated, immediate-release tablets taken orally.

    Arm title
    		 Selinexor 60 mg (8 doses/cycle)
    Arm description
    		 Subjects received a fixed dose of 60 mg of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-4 (8 doses/cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Selinexor
    Investigational medicinal product code
    KPT-330
    Other name
    XPOVIO, NEXPOVIO
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg and 50 mg coated, immediate-release tablets taken orally.

    Number of subjects in period 1
    		Selinexor 60 mg/m^2 (8 Doses/Cycle) Selinexor 60 mg (6 doses/cycle) Selinexor 60 mg (8 doses/cycle)
    Started
    3
    15
    8
    Completed
    0
    0
    0
    Not completed
    3
    15
    8
         Consent withdrawn by subject
    1
    2
    -
         Disease progression
    1
    1
    3
         Adverse event, non-fatal
    -
    2
    1
         Patient's wish
    -
    2
    -
         Death
    1
    7
    2
         Sponsor termination of study
    -
    1
    1
         Noncompliance
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Selinexor 60 mg/m^2 (8 Doses/Cycle)
    Reporting group description
    		 Subjects received a dose of 60 milligrams/square meter (mg/m^2) of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-4 (8 doses/cycle).

    Reporting group title
    Selinexor 60 mg (6 doses/cycle)
    Reporting group description
    		 Subjects received a dose of 60 milligrams (mg) of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-3 (6 doses/cycle).

    Reporting group title
    Selinexor 60 mg (8 doses/cycle)
    Reporting group description
    		 Subjects received a fixed dose of 60 mg of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-4 (8 doses/cycle).

    Reporting group values
    		 Selinexor 60 mg/m^2 (8 Doses/Cycle) Selinexor 60 mg (6 doses/cycle) Selinexor 60 mg (8 doses/cycle) Total
    Number of subjects
    		 3 15 8 26
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    		 68 (66 to 74) 68 (41 to 77) 69 (65 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 2 3 4 9
        Male
    		 1 12 4 17
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 1 0 2
        Not Hispanic or Latino
    		 1 14 8 23
        Unknown or Not Reported
    		 1 0 0 1
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 3 15 8 26
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    ECOG score
    Performance Status as measured by Eastern Cooperative Oncology Group (ECOG) Status Scale: Score=0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction; Score=1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work); Score=2: In bed < 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
    Units: Subjects
        Score=0
    		 0 5 2 7
        Score=1
    		 3 6 4 13
        Score=2
    		 0 4 1 5
        Missing
    		 0 0 1 1
    Weight
    Units: Kilograms
        median (full range (min-max))
    		 56.5 (52.3 to 96.0) 76.5 (51.9 to 115.5) 73.05 (46.4 to 88.1) -

    End points

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    End points reporting groups
    Reporting group title
    Selinexor 60 mg/m^2 (8 Doses/Cycle)
    Reporting group description
    		 Subjects received a dose of 60 milligrams/square meter (mg/m^2) of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-4 (8 doses/cycle).

    Reporting group title
    Selinexor 60 mg (6 doses/cycle)
    Reporting group description
    		 Subjects received a dose of 60 milligrams (mg) of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-3 (6 doses/cycle).

    Reporting group title
    Selinexor 60 mg (8 doses/cycle)
    Reporting group description
    		 Subjects received a fixed dose of 60 mg of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-4 (8 doses/cycle).

    Subject analysis set title
    Selinexor
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects who received at least 1 dose of study medication and had post-baseline efficacy follow-up information.

    Primary: Percentage of Subjects With Overall Response Rate (ORR)

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    End point title
    		 Percentage of Subjects With Overall Response Rate (ORR) [1]
    End point description
    ORR was defined as the point estimate of the percentage of subjects who have complete response (CR) or partial response (PR). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. CR was defined as disappearance of all evidence of disease, and PR was defined as ≥ 50% regression of measurable disease and no new sites. Modified Intent to Treat (mITT) population, consisting of all subjects who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Subjects without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
    End point type
    Primary
    End point timeframe
    Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
    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 testing was performed for the primary end point.
    End point values
    		 Selinexor
    Number of subjects analysed
    25
    Units: Percentage of subjects
        number (confidence interval 95%)
    4 (0.1 to 20.4)
    No statistical analyses for this end point

    Primary: Number of Subjects With Complete Response (CR)

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    End point title
    		 Number of Subjects With Complete Response (CR) [2]
    End point description
    Number of Subjects who achieved CR (complete disappearance of all detectable evidence of disease). Disease response was assessed using the IWG Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. mITT population, consisting of all subjects who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Subjects without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
    End point type
    Primary
    End point timeframe
    Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
    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 testing was performed for the primary end point.
    End point values
    		 Selinexor
    Number of subjects analysed
    25
    Units: Subjects
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Partial Response (PR)

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    End point title
    		 Number of Subjects With Partial Response (PR) [3]
    End point description
    Number of subjects whose best overall response to study treatment was PR (≥ 50% regression of measurable disease and no new sites). Disease response was assessed using the IWG Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. mITT population, consisting of all subjects who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Subjects without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
    End point type
    Primary
    End point timeframe
    Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
    Notes
    [3] - 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 testing was performed for the primary end point.
    End point values
    		 Selinexor
    Number of subjects analysed
    25
    Units: Subjects
    1
    No statistical analyses for this end point

    Primary: Number of Subjects With Stable Disease (SD)

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    End point title
    		 Number of Subjects With Stable Disease (SD) [4]
    End point description
    Number of subjects whose best overall response to study treatment was SD (failure to attain criteria for CR or PR, or to meet criteria for PD). Disease response was assessed using the IWG Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. mITT population, consisting of all subjects who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Subjects without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
    End point type
    Primary
    End point timeframe
    Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
    Notes
    [4] - 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 testing was performed for the primary end point.
    End point values
    		 Selinexor
    Number of subjects analysed
    25
    Units: Subjects
    6
    No statistical analyses for this end point

    Primary: Number of Subjects With Progressive Disease (PD)

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    End point title
    		 Number of Subjects With Progressive Disease (PD) [5]
    End point description
    Number of subjects whose best overall response to study treatment was PD (any new lesion or increase by ≥ 50% of previously involved sites from nadir). Disease response was assessed using the IWG Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. mITT population, consisting of all subjects who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Subjects without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
    End point type
    Primary
    End point timeframe
    Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
    Notes
    [5] - 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 testing was performed for the primary end point.
    End point values
    		 Selinexor
    Number of subjects analysed
    25
    Units: Subjects
    7
    No statistical analyses for this end point

    Primary: Number of Subjects With Not Evaluable (NE) Response

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    End point title
    		 Number of Subjects With Not Evaluable (NE) Response [6]
    End point description
    Number of subjects who could not be assessed quantitatively for disease response for any reason. mITT population, consisting of all subjects who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Subjects without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
    End point type
    Primary
    End point timeframe
    Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
    Notes
    [6] - 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 testing was performed for the primary end point.
    End point values
    		 Selinexor
    Number of subjects analysed
    25
    Units: Subjects
    11
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Disease Control Rate (DCR)

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    End point title
    		 Percentage of Subjects With Disease Control Rate (DCR)
    End point description
    DCR was defined as the percentage of subjects who achieved CR, PR, or SD lasting for at least 8 weeks. CR was defined as disappearance of all evidence of disease. PR was defined as ≥ 50% regression of measurable disease and no new sites. SD was defined as failure to attain criteria for CR or PR, or to meet criteria for PD. Disease response was assessed using the IWG Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. mITT population, consisting of all subjects who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Subjects without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.
    End point type
    Secondary
    End point timeframe
    Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
    End point values
    		 Selinexor
    Number of subjects analysed
    25
    Units: Percentage of subjects
        number (confidence interval 95%)
    28.0 (12.1 to 49.4)
    No statistical analyses for this end point

    Secondary: Duration of Progression Free Survival (PFS)

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    End point title
    		 Duration of Progression Free Survival (PFS)
    End point description
    Number of days calculated from date of start of study therapy to date of progression based on IWG criteria, or date of death if progression did not occur. Subjects who dropped out prior to study end without evidence of disease progression were censored at the day they were last known to be alive. Subjects without documented disease progression or recurrence were censored at the date of last disease assessment. Disease response was assessed using the IWG Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. Analysis was performed by mITT population.
    End point type
    Secondary
    End point timeframe
    Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.
    End point values
    		 Selinexor
    Number of subjects analysed
    25
    Units: Days
        median (confidence interval 95%)
    38.0 (22.0 to 86.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent AEs were collected from the first day of dosing (Cycle 1 Day 1) through the 30-day follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Selinexor 60 mg/m^2 (8 Doses/Cycle)
    Reporting group description
    		 Subjects received a dose of 60 mg/m^2 of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-4 (8 doses/cycle).

    Reporting group title
    Selinexor 60 mg (6 doses/cycle)
    Reporting group description
    		 Subjects received a dose of 60 mg of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-3 (6 doses/cycle).

    Reporting group title
    Selinexor 60 mg (8 doses/cycle)
    Reporting group description
    		 Subjects received a fixed dose of 60 mg of selinexor oral tablets twice weekly (Days 1 and 3) for weeks 1-4 (8 doses/cycle).

    Serious adverse events
    		 Selinexor 60 mg/m^2 (8 Doses/Cycle) Selinexor 60 mg (6 doses/cycle) Selinexor 60 mg (8 doses/cycle)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    9 / 15 (60.00%)
    5 / 8 (62.50%)
         number of deaths (all causes)
    1
    8
    2
         number of deaths resulting from adverse events
    0
    4
    0
    Investigations
    Clostridium test
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Embolism arterial
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    2 / 8 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Staphylococcal infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food intolerance
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Selinexor 60 mg/m^2 (8 Doses/Cycle) Selinexor 60 mg (6 doses/cycle) Selinexor 60 mg (8 doses/cycle)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    15 / 15 (100.00%)
    7 / 8 (87.50%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    2
    Tumour Associated Fever
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 15 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    3
    0
    2
    Haematoma
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Embolism
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Hot Flush
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Pallor
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Phlebitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Post Procedural Contusion
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 3 (33.33%)
    6 / 15 (40.00%)
    2 / 8 (25.00%)
         occurrences all number
    1
    7
    2
    Fatigue
         subjects affected / exposed
    2 / 3 (66.67%)
    4 / 15 (26.67%)
    2 / 8 (25.00%)
         occurrences all number
    2
    5
    7
    Asthenia
         subjects affected / exposed
    1 / 3 (33.33%)
    4 / 15 (26.67%)
    2 / 8 (25.00%)
         occurrences all number
    1
    5
    2
    Oedema peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    5 / 15 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    7
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    Early Satiety
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Facial Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Oedema Genital
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Pelvic Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    3 / 8 (37.50%)
         occurrences all number
    1
    1
    3
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    1
    Haemoptysis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Pleural Effusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Pulmonary Embolism
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 15 (13.33%)
    1 / 8 (12.50%)
         occurrences all number
    1
    2
    1
    Weight decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    3 / 8 (37.50%)
         occurrences all number
    0
    0
    4
    C-reactive protein increased
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    3
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Creatinine Phophokinase Decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Blood Creatinine Phosphokinase Increased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Hypophonesis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    International Normalised Ratio Increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Protein Total Decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Post Procedural Haematoma
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Skain Abrasion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    4 / 8 (50.00%)
         occurrences all number
    0
    1
    4
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 15 (20.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    4
    0
    Dysgeusia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    3
    Aphasia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Ataxia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Horner's Syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Hypokinesia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Lethargy
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Migraine With Aura
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous System Disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Visual Field Defect
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 3 (33.33%)
    8 / 15 (53.33%)
    5 / 8 (62.50%)
         occurrences all number
    1
    16
    13
    Anaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    5 / 15 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    1
    7
    1
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 15 (20.00%)
    3 / 8 (37.50%)
         occurrences all number
    0
    5
    13
    Leukopenia
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 15 (13.33%)
    2 / 8 (25.00%)
         occurrences all number
    1
    3
    4
    Leukocytosis
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    Pancytopenia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    Febrile Neutropenia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Vertigo
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Eye Irritation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Ocular Toxicity
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Photophobia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Vision Blurred
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 3 (66.67%)
    8 / 15 (53.33%)
    3 / 8 (37.50%)
         occurrences all number
    2
    11
    3
    Diarrhoea
         subjects affected / exposed
    1 / 3 (33.33%)
    5 / 15 (33.33%)
    3 / 8 (37.50%)
         occurrences all number
    1
    7
    3
    Vomiting
         subjects affected / exposed
    1 / 3 (33.33%)
    7 / 15 (46.67%)
    1 / 8 (12.50%)
         occurrences all number
    1
    11
    1
    Constipation
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 15 (13.33%)
    2 / 8 (25.00%)
         occurrences all number
    1
    2
    2
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    Anal incontinence
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    Dry mouth
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Melaena
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Rectal Haemorrhage
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Tongue Coated
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    5
    0
    Jaundice
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    1
    0
    Erythema
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Skin Discolouration
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Skin Lesion
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Urinary incontinence
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    Haematuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Incontinence
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Renal Failure
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 3 (33.33%)
    4 / 15 (26.67%)
    0 / 8 (0.00%)
         occurrences all number
    1
    4
    0
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Hypercreatinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    0
    0
    2
    Pain in extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    Groin Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Muscular Weakness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Myopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    2 / 8 (25.00%)
         occurrences all number
    0
    1
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    1
    Oral infection
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Bacteriuria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Clostridium Difficile Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Device Related Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes Ophthalmic
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Oral Herpes
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Osteomyelitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Sepsis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 3 (66.67%)
    5 / 15 (33.33%)
    2 / 8 (25.00%)
         occurrences all number
    2
    6
    3
    Hyponatraemia
         subjects affected / exposed
    1 / 3 (33.33%)
    4 / 15 (26.67%)
    2 / 8 (25.00%)
         occurrences all number
    1
    4
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    3 / 8 (37.50%)
         occurrences all number
    1
    1
    4
    Hypocalcaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    2 / 8 (25.00%)
         occurrences all number
    1
    1
    2
    Hypercalcaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
         occurrences all number
    1
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
         occurrences all number
    1
    8
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 15 (13.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    1
    Hypercreatininaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    1
    Cachexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Dehydration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Hypermagnesaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    1
    Hypochloraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2014
    Protocol Amendment 1: - Addressed comments following Health Authority review to exclude subjects with surface antigen (HBsAg) or hepatitis B PCR positivity. - Revised selinexor risk section to remove “without bleeding” from “low platelets without bleeding”. - Washout period for prior ibrutinib was changed from ≥2 weeks to 1 day prior to initiation of selinexor. - Clarified that lymph node biopsy was required, but only if it was safe for the subject to undergo biopsy. - Added description of an acute cerebellar syndrome SAE to the risks/ SAE reporting sections.
    04 Nov 2014
    Protocol Amendment 2: - Treatment holiday was added (dosing on Weeks 1-3, with no treatment during Week 4).
    18 Dec 2014
    Protocol Amendment 3: - Reduced the starting dose of selinexor to a fixed 60 mg (~35 mg/square-meter) twice weekly (Days 1 and 3 of a 3-week cycle) for all subjects with body surface area ≥ 1.3 square-meter. - Increased selinexor dose to 80 mg at Cycle 3/Day 1 unless clinically contraindicated (eg, persistent severe thrombocytopenia or fatigue) (Note: previously, dosing could be up to 120 mg for subjects with a BSA ≥ 2.0 square-meter). - Excluded subjects with body surface areas < 1.3 square-meter due to potential for tolerance issues.
    22 Jun 2015
    Protocol Amendment 4: - Replaced the requirement for prior Richter’s therapy with requirement for prior CLL therapy. - Specified the objective evidence of disease progression required for subject inclusion. - Allowed subjects with liver involvement of their RT who had AST and ALT ≤ 5×ULN to enroll in the study. - Increased the windows for certain Screening assessments. - Moved assessments (eg, IgVH, karyotyping, quality of life, oxygen saturation) that were not required for Screening to Cycle 1/Day 1. - Provided additional monitoring for pregnancies. - Added analysis at a central laboratory to characterize tumor histology and confirm RT. - Replaced Follow-up Visit at 30 days after the Final Visit with a telephone call 30 days after the last dose of study treatment. * Subjects receiving ongoing treatment in 3-week cycles were permitted to continue with their original treatment regimen or switch to 4-week cycles. In addition, dosing was permitted to be increased after Cycle 1 to 80 mg twice weekly for those subjects who had no contraindicated toxicity. - Aligned steroid use with study KCP-330-009. - Update ophthalmic examination language and appendix. - Update safety reporting.

    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.
    The low number of formal objective responses (leading to the termination of the study following the first stage), coupled with the high number of censored observations, limited meaningful analyses and the ability to draw conclusions from the data.
    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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