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    Clinical Trial Results:
    An Open-Label Extension Study to Allow Continued Dosing and/or Follow-up of Patients who have had Previous Exposure to Poziotinib

    Summary
    EudraCT number
    		 2020-005213-40
    Trial protocol
    		 IT  
    Global end of trial date
    03 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Apr 2024
    First version publication date
    19 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SPI-POZ-501
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03744715
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Spectrum Pharmaceuticals, Inc.
    Sponsor organisation address
    Research and Development Office, 157 Technology Dr W, Irvine, California, United States, 92618
    Public contact
    Howard Franklin, Assertio Holdings, 00 224 419 7106, Hfranklin@assertiotx.com
    Scientific contact
    Howard Franklin, Assertio Holdings, 00 224 419 7106, Hfranklin@assertiotx.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
    03 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this extension study was to provide the clinical benefit of poziotinib to participants who were responding to treatment.
    Protection of trial subjects
    This study was conducted in accordance with good clinical practice (GCP) and with the internal standard operating procedures (SOPs) of Spectrum Pharmaceuticals, Inc. A study-specific written informed consent was signed by each subject prior to any study-related assessments or procedures that were conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 2018
    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
    Worldwide total number of subjects
    7
    EEA total number of subjects
    0
    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
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at investigative sites across the United States from 11 October 2018 to 03 March 2023.

    Pre-assignment
    Screening details
    		 A total of 7 participants were enrolled and dosed with Poziotinib.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Poziotinib 6 mg
    Arm description
    		 Participants started poziotinib 6 mg twice a day (BID) in a 21-day cycle in the current study after having received 16 mg once daily (QD) in the parent study NCT03318939.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Poziotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Poziotinib 6 mg administered orally, once daily

    Arm title
    		 Poziotinib 8 mg
    Arm description
    		 Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Poziotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Poziotinib 8 mg administered orally, once daily

    Arm title
    		 Poziotinib 12 mg
    Arm description
    		 Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Poziotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Poziotinib 12 mg administered orally, once daily

    Arm title
    		 Poziotinib 14 mg
    Arm description
    		 Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Poziotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Poziotinib 14 mg administered orally, once daily

    Arm title
    		 Poziotinib 16 mg
    Arm description
    		 Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Poziotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Poziotinib 16 mg administered orally, once daily

    Arm title
    		 Poziotinib 24 mg
    Arm description
    		 Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Poziotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Poziotinib 24 mg administered orally, once daily

    Number of subjects in period 1
    		Poziotinib 6 mg Poziotinib 8 mg Poziotinib 12 mg Poziotinib 14 mg Poziotinib 16 mg Poziotinib 24 mg
    Started
    1
    1
    1
    1
    2
    1
    Completed
    0
    0
    0
    0
    0
    0
    Not completed
    1
    1
    1
    1
    2
    1
         Initiation of another anti-malignancy therapy
    -
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    -
    1
    -
    -
         Disease progression
    -
    1
    -
    -
    1
    1
         Adverse event, non-fatal
    -
    -
    -
    -
    1
    -
         Study terminated by sponsor
    1
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Poziotinib 6 mg
    Reporting group description
    		 Participants started poziotinib 6 mg twice a day (BID) in a 21-day cycle in the current study after having received 16 mg once daily (QD) in the parent study NCT03318939.

    Reporting group title
    Poziotinib 8 mg
    Reporting group description
    		 Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.

    Reporting group title
    Poziotinib 12 mg
    Reporting group description
    		 Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.

    Reporting group title
    Poziotinib 14 mg
    Reporting group description
    		 Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.

    Reporting group title
    Poziotinib 16 mg
    Reporting group description
    		 Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.

    Reporting group title
    Poziotinib 24 mg
    Reporting group description
    		 Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.

    Reporting group values
    		 Poziotinib 6 mg Poziotinib 8 mg Poziotinib 12 mg Poziotinib 14 mg Poziotinib 16 mg Poziotinib 24 mg Total
    Number of subjects
    		 1 1 1 1 2 1 7
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 1 2 1 4
        From 65-84 years
    		 1 1 1 0 0 0 3
        85 years and over
    		 0 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 1 1 0 1 1 4
        Male
    		 1 0 0 1 1 0 3

    End points

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    End points reporting groups
    Reporting group title
    Poziotinib 6 mg
    Reporting group description
    		 Participants started poziotinib 6 mg twice a day (BID) in a 21-day cycle in the current study after having received 16 mg once daily (QD) in the parent study NCT03318939.

    Reporting group title
    Poziotinib 8 mg
    Reporting group description
    		 Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.

    Reporting group title
    Poziotinib 12 mg
    Reporting group description
    		 Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.

    Reporting group title
    Poziotinib 14 mg
    Reporting group description
    		 Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.

    Reporting group title
    Poziotinib 16 mg
    Reporting group description
    		 Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.

    Reporting group title
    Poziotinib 24 mg
    Reporting group description
    		 Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.

    Primary: Number of Participants With Adverse Events (AEs)

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    End point title
    		 Number of Participants With Adverse Events (AEs) [1]
    End point description
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Analysis population included all participants who had previous exposure to poziotinib. The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
    End point type
    Primary
    End point timeframe
    Up to 40 days after the last dose of the study drug (Up to 197 weeks)
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Poziotinib 6 mg Poziotinib 8 mg Poziotinib 12 mg Poziotinib 14 mg Poziotinib 16 mg Poziotinib 24 mg
    Number of subjects analysed
    1
    1
    1
    1
    2
    1
    Units: subjects
        Number of Participants With Adverse Events (AEs)
    1
    1
    1
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR)
    End point description
    ORR was defined as the percentage of participants with confirmed complete response (CR) and partial response (PR) as assessed by the investigator using local radiology evaluation according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
    End point type
    Secondary
    End point timeframe
    Up to 191 weeks
    End point values
    		 Poziotinib 6 mg Poziotinib 8 mg Poziotinib 12 mg Poziotinib 14 mg Poziotinib 16 mg Poziotinib 24 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    Units: percentage of subjects
        Overall Number of Participants Analyzed
    Notes
    [2] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [3] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [4] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [5] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [6] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [7] - The study was terminated early due to business decision, the data was not analyzed as planned.
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR)

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    End point title
    		 Disease Control Rate (DCR)
    End point description
    DCR is defined as percentage of participants with best response of CR, PR, and stable disease (SD) from the first dose of poziotinib to the end of study. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
    End point type
    Secondary
    End point timeframe
    Up to 191 weeks
    End point values
    		 Poziotinib 6 mg Poziotinib 8 mg Poziotinib 12 mg Poziotinib 14 mg Poziotinib 16 mg Poziotinib 24 mg
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    Units: percentage of subjects
        Overall Number of Participants Analyzed
    Notes
    [8] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [9] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [10] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [11] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [12] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [13] - The study was terminated early due to business decision, the data was not analyzed as planned.
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    Duration of response was defined as the time from the date that measurement criteria are first met for CR or PR until the first subsequent date that progressive disease or death is documented. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must have a reduction in the short axis to <10 mm. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
    End point type
    Secondary
    End point timeframe
    Up to 191 Weeks
    End point values
    		 Poziotinib 6 mg Poziotinib 8 mg Poziotinib 12 mg Poziotinib 14 mg Poziotinib 16 mg Poziotinib 24 mg
    Number of subjects analysed
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    Units: Months
        Overall Number of Participants Analyzed
    Notes
    [14] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [15] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [16] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [17] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [18] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [19] - The study was terminated early due to business decision, the data was not analyzed as planned.
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS was the duration of time from first administration of study treatment to date of first documented disease progression or death from any cause. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in the sum of diameters of target lesions, unequivocal progression in non-target lesions, and/or appearance of new lesions. As the study was terminated early due to a business decision, with lack of enrollment, the data for this outcome measure was not collected or analyzed as planned.
    End point type
    Secondary
    End point timeframe
    Up to 191 Weeks
    End point values
    		 Poziotinib 6 mg Poziotinib 8 mg Poziotinib 12 mg Poziotinib 14 mg Poziotinib 16 mg Poziotinib 24 mg
    Number of subjects analysed
    0 [20]
    0 [21]
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    Units: Months
        Overall Number of Participants Analyzed
    Notes
    [20] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [21] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [22] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [23] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [24] - The study was terminated early due to business decision, the data was not analyzed as planned.
    [25] - The study was terminated early due to business decision, the data was not analyzed as planned.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 40 days after the last dose of the study drug (Up to 197 weeks)
    Adverse event reporting additional description
    The Safety Analysis Population included all the enrolled participants who received at least one dose of poziotinib.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Poziotinib 6 mg
    Reporting group description
    		 Participants started poziotinib 6 mg twice a day (BID) in a 21-day cycle in the current study after having received 16 mg once daily (QD) in the parent study NCT03318939.

    Reporting group title
    Poziotinib 8 mg
    Reporting group description
    		 Participants started poziotinib 8 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.

    Reporting group title
    Poziotinib 12 mg
    Reporting group description
    		 Participants started poziotinib 12 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT03318939.

    Reporting group title
    Poziotinib 14 mg
    Reporting group description
    		 Participants started poziotinib 14 mg QD in a 21-day cycle in the current study after having received 16 mg QD in the parent study NCT03318939.

    Reporting group title
    Poziotinib 16 mg
    Reporting group description
    		 Participants started poziotinib at 16 mg QD in a 21-day cycle in the current study after having received 12 mg QD in the parent study NCT03804515.

    Reporting group title
    Poziotinib 24 mg
    Reporting group description
    		 Participants started poziotinib at 24 mg QD in a 21-day cycle in the current study after having received same dose in the parent study NCT02659514.

    Serious adverse events
    		 Poziotinib 6 mg Poziotinib 8 mg Poziotinib 12 mg Poziotinib 14 mg Poziotinib 16 mg Poziotinib 24 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Poziotinib 6 mg Poziotinib 8 mg Poziotinib 12 mg Poziotinib 14 mg Poziotinib 16 mg Poziotinib 24 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    2 / 2 (100.00%)
    1 / 1 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Chills
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 2 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Confusional state
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Investigations
    Amylase Increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    0
    2
    0
    Lipase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Skin abrasion
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Lethargy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Syncope
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    16
    5
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 2 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Nausea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    Stomatitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 2 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    7
    0
    Dry skin
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 2 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    4
    0
    0
    4
    0
    Skin atrophy
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Hematuria
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Proteinuria
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    2
    6
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    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
    27 Nov 2019
    1. This study has been open to all participants who have had previous exposure to poziotinib, including participants in Investigator-Initiated Studies (IIS) as long as the participant is receiving clinical benefit, as judged by the Investigator or treating physician. 2. In order to conduct analyses with data from these participants, specific assessments and their timing have been added: • Addition of a summary of assessments and procedures table. • Assessments must be at least every 2 cycles of treatment • Added detailed explanations for assessments and procedures in Section 5, Study Procedures 3. The participant's last dose before entering the study was changed from “cannot be more than 20 days” to “cannot be more than 28 days”. 4. The study title changed to "An Open-Label Extension Study to Allow Continued Dosing and/or Follow-up of Patients who have had Previous Exposure to Poziotinib" from "An Open-Label Extension Study to Allow Continued Treatment of Patients who have Participated in a Spectrum-Sponsored Poziotinib Study". 5. The primary objective changed to "To continue to monitor patients who appear to derive clinical benefit from poziotinib" from "To continue to provide clinical benefit to patients who have participated in Spectrum-sponsored studies with poziotinib". 6. Removal of inclusion criteria "Patient did not meet any treatment discontinuation criteria other than completing maximum treatment time of the original Spectrum-sponsored Study". 7. Removal of exclusion criteria "Patient is receiving any other treatment modalities with curative intent for his or her malignancy, including investigational products other than poziotinib. Therapies to palliate local symptoms will be allowed (e.g. radiation for focal bone metastasis). 8. Addition of exclusion criteria "Patient’s last dose of poziotinib was more than 28 days prior to Day 1 of the study".
    27 Nov 2019
    9. Removed the reference to SPI-POZ-102 and stated that participants can be treated at their last dose or at 16 mg/day in Section 6.1.3: Poziotinib Administration. 10. Added the standard dose modification instructions that are used in other poziotinib studies in Section 6.4: Poziotinib Dose Delays and Modifications. Dose reductions below 8 mg are not recommended in the study. 11. The evaluation of participants and the collecting of data was formalized in Section 5.1: Screening.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    03 Mar 2023
    Study was terminated due to business reasons, not related to safety.
    -

    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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