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    Clinical Trial Results:
    A Safety Study of Oraxol (HM30181 + oral paclitaxel) in Cancer Patients

    Summary
    EudraCT number
    		 2017-004578-33
    Trial protocol
    		 GB  
    Global end of trial date
    15 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2023
    First version publication date
    01 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KX-ORAX-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1170-6641
    Sponsors
    Sponsor organisation name
    Athenex, Inc. doing business as Kinex Pharmaceuticals, Inc.
    Sponsor organisation address
    20 Commerce Drive, Cranford, United States, NJ 07016
    Public contact
    Ashleigh Lamson, Athenex, Inc. , 1-716 427-2950, ashleighlamson@athenex.com
    Scientific contact
    Rudolf Kwan, MD, Athenex, Inc. , 1-716 427-2950, rkwan@kinexpharma.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
    15 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to determine the safety and tolerability of Oraxol.
    Protection of trial subjects
    This study was conducted in accordance with all stipulations of the protocol and in accordance with International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) guidelines, including the Declaration of Helsinki. Subjects were monitored for adverse events with any serious adverse events (SAEs) reported to the study sponsor and reviewed by the KX-ORAX-003 data safety monitoring board. Monitoring visits to each site were conducted to assess adherence to the study protocol, data accuracy and compliance with GCP and local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Taiwan: 9
    Country: Number of subjects enrolled
    New Zealand: 30
    Worldwide total number of subjects
    44
    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)
    30
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible participants were adults with cancer for whom weekly IV paclitaxel therapy was indicated (including subjects who had completed the KX-ORAX-002 trial). Subjects were recruited from 8 sites in 4 countries (UK, Taiwan, Australia and New Zealand).

    Pre-assignment
    Screening details
    		 45 participants were screened. One participant was excluded due to a screening failure (failure to meet all inclusion criteria).

    Pre-assignment period milestones
    Number of subjects started
    		 45 [1]
    Number of subjects completed
    		 44

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening Failure: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 45 patients signed the ICF however there was 1 screen failure. 44 patients were dosed according to the protocol.
    Period 1
    Period 1 title
    Oraxol (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Oraxol
    Arm description
    		 All subjects (Group A) received oral HM30181A × 3 consecutive days weekly (1 hour before paclitaxel) + oral paclitaxel capsule on 3 consecutive days weekly. Group B: (sub-group) in addition to Group A treatment also received oral paclitaxel tablets on 3 consecutive days weekly (for 1 week only at Week 5 or later) and underwent a second pharmacokinetic (PK) period to determine bioavailability.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HM30181A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral HM30181A (supplied as 15-mg HM30181AK-US tablets equivalent to 12.9 mg of encequidar free base). Administrated 15 mg daily on 3 consecutive days weekly (1 hour before paclitaxel).

    Investigational medicinal product name
    Paclitaxel (capsule)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral paclitaxel capsule 30mg. Administrated 205 mg/m2 daily on 3 consecutive days weekly.

    Investigational medicinal product name
    Paclitaxel (tablet)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Group B only: Oral paclitaxel tablet 30mg. Administrated 205 mg/m2 daily on 3 consecutive days weekly (for 1 week only at Week 5 or later)

    Number of subjects in period 1
    		Oraxol
    Started
    44
    Completed
    0
    Not completed
    44
         Physician decision
    1
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    7
         Progressive disease
    33

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oraxol
    Reporting group description
    		 Oraxol (oral paclitaxel + HM30181A): Oral HM30181A 15 mg daily × 3 consecutive days weekly (1 hour before paclitaxel) plus oral paclitaxel 205 mg/m2 daily × 3 consecutive days weekly

    Reporting group values
    		 Oraxol Total
    Number of subjects
    		 44 44
    Age categorical
    The youngest subject was 32 years, the oldest 77 years (in Group B the youngest subject was 43 years, the oldest 75 years)
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 30 30
        From 65-84 years
    		 14 14
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.9 ( 10.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 14 14
    Ethnic group
    Units: Subjects
        Asian - China
    		 1 1
        Asian - Other
    		 10 10
        Native Hawaiian or Other Pacific Islander
    		 1 1
        White
    		 32 32
    Primary Cancer Diagnosis
    Units: Subjects
        Breast
    		 25 25
        Esophageal
    		 4 4
        Gastric
    		 3 3
        Bile duct
    		 2 2
        Ovarian
    		 2 2
        Prostate
    		 2 2
        Vascular
    		 2 2
        Other
    		 4 4
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 71.7 ( 15.5 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 166.4 ( 8.2 ) -
    Body Surface Area (BSA)
    Units: m2
        arithmetic mean (standard deviation)
    		 1.8 ( 0.2 ) -
    Subject analysis sets

    Subject analysis set title
    Oraxol (Group B)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    A subgroup of participants (i.e., Group B) to determine the bioavailability of paclitaxel tablets versus paclitaxel capsules

    Subject analysis sets values
    		 Oraxol (Group B)
    Number of subjects
    10
    Age categorical
    The youngest subject was 32 years, the oldest 77 years (in Group B the youngest subject was 43 years, the oldest 75 years)
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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 65-84 years
    4
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    60.2 ( 10.7 )
    Gender categorical
    Units: Subjects
        Female
    5
        Male
    5
    Ethnic group
    Units: Subjects
        Asian - China
    0
        Asian - Other
    4
        Native Hawaiian or Other Pacific Islander
    0
        White
    6
    Primary Cancer Diagnosis
    Units: Subjects
        Breast
    5
        Esophageal
    2
        Gastric
    1
        Bile duct
    0
        Ovarian
    0
        Prostate
    0
        Vascular
    1
        Other
    1
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    72.8 ( 16.6 )
    Height
    Units: cm
        arithmetic mean (standard deviation)
    165.6 ( 5.9 )
    Body Surface Area (BSA)
    Units: m2
        arithmetic mean (standard deviation)
    1.8 ( 0.2 )

    End points

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    End points reporting groups
    Reporting group title
    Oraxol
    Reporting group description
    		 All subjects (Group A) received oral HM30181A × 3 consecutive days weekly (1 hour before paclitaxel) + oral paclitaxel capsule on 3 consecutive days weekly. Group B: (sub-group) in addition to Group A treatment also received oral paclitaxel tablets on 3 consecutive days weekly (for 1 week only at Week 5 or later) and underwent a second pharmacokinetic (PK) period to determine bioavailability.

    Subject analysis set title
    Oraxol (Group B)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    A subgroup of participants (i.e., Group B) to determine the bioavailability of paclitaxel tablets versus paclitaxel capsules

    Primary: Number of subjects with at least one treatment emergent adverse event (TEAE)

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    End point title
    		 Number of subjects with at least one treatment emergent adverse event (TEAE) [1]
    End point description
    Adverse events with an onset after dosing and those pre-existing AEs that worsen during the study. The TEAE classified as "related" are those judged “definitely related,” “probably related,” or “possibly related” to Oraxol by the investigator.
    End point type
    Primary
    End point timeframe
    From signing of informed consent form (ICF) to final study visit
    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 quantitative statistical analysis was performed for this end point.
    End point values
    		 Oraxol
    Number of subjects analysed
    44
    Units: Subjects
        TEAE - overall
    43
        TEAE - related to Oraxol
    41
    No statistical analyses for this end point

    Primary: Number of subjects with at least one serious adverse event (SAE)

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    End point title
    		 Number of subjects with at least one serious adverse event (SAE) [2]
    End point description
    Number of serious adverse events (SAEs) experienced by subjects who had received Oraxol. A SAE was defined as any untoward medical occurrence that at any dose: resulted in death, was life threatening (i.e., the participant was at immediate risk of death from the AE as it occurred), required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). Other important medical events that may not have been immediately life threatening or resulted in death or hospitalization but, when based on appropriate medical judgment, may have jeopardized the participant or may have required intervention to prevent one of the outcomes in the definition of SAE listed above, were also to be considered SAEs.
    End point type
    Primary
    End point timeframe
    Signing of informed consent form (ICF) to final study visit
    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 quantitative statistical analysis was performed for this end point.
    End point values
    		 Oraxol
    Number of subjects analysed
    44
    Units: Subjects
        Serious TEAE - all events
    14
        Serious TEAE - related to Oraxol
    7
    No statistical analyses for this end point

    Primary: Number of subjects with clinically important changes in vital signs

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    End point title
    		 Number of subjects with clinically important changes in vital signs [3]
    End point description
    Number of subjects with changes in vital signs (heart rate [HR], respiratory rate [RR], systolic and diastolic blood pressure [BP], body temperature) during study treatment where change assessed as clinically important
    End point type
    Primary
    End point timeframe
    From baseline to final study visit
    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 quantitative statistical analysis was performed for this end point.
    End point values
    		 Oraxol
    Number of subjects analysed
    44
    Units: Subjects
        Change in HR - CS
    0
        Change in BP - CS
    0
        Change in RR - CS
    0
        Change in body temperature - CS
    0
    No statistical analyses for this end point

    Primary: Number of subjects with clinically important abnormality on ECG (PR, QRS, QT and QTc intervals)

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    End point title
    		 Number of subjects with clinically important abnormality on ECG (PR, QRS, QT and QTc intervals) [4]
    End point description
    Number of subjects with a clinically significant ECG abnormality (as interpreted by the investigator) during study treatment.
    End point type
    Primary
    End point timeframe
    From baseline to final visit
    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 quantitative statistical analysis was performed for this end point.
    End point values
    		 Oraxol
    Number of subjects analysed
    44
    Units: Subject
        ECG - clinically significant abnormality
    0
    No statistical analyses for this end point

    Primary: ECOG Performance Status at Final Visit

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    End point title
    		 ECOG Performance Status at Final Visit [5]
    End point description
    Easter Cooperative Oncology Group (ECOG) Performance Status (PS) at final study visit. ECOG PS is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis (on decreasing scale from PS =0 being fully active). All patients recruited to the trial had PS of either 0 or 1 when recruited to the trial as per the study inclusion criteria.
    End point type
    Primary
    End point timeframe
    Final study visit
    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 quantitative statistical analysis was performed for this end point.
    End point values
    		 Oraxol
    Number of subjects analysed
    39
    Units: ECOG score
        ECOG PS Score 0
    10
        ECOG PS Score 1
    25
        ECOG PS Score 2
    1
        ECOG PS Score 3
    3
        ECOG PS Score 4
    0
        ECOG PS Score 5
    0
    No statistical analyses for this end point

    Primary: Number of subjects with a shift in laboratory values (Hematology) from baseline to worst toxicity grade during treatment

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    End point title
    		 Number of subjects with a shift in laboratory values (Hematology) from baseline to worst toxicity grade during treatment [6]
    End point description
    Changes in laboratory values (hematology) during study treatment as defined by maximum CTCAE toxicity grade (Grade 0 = within normal levels, Grade 1 = mild, 2 = moderate, 3 severe, 4 = life threatening; 5 = death related to AE)
    End point type
    Primary
    End point timeframe
    From baseline to final study visit
    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 quantitative statistical analysis was performed for this end point.
    End point values
    		 Oraxol
    Number of subjects analysed
    44
    Units: Subjects
        Hemoglobin decreased - grade 3
    2
        Hemoglobin decreased - grade 2
    9
        Hemoglobin decreased - grade 1
    25
        Hemoglobin decreased - grade 0
    8
        Platelet count decreased - grade 2
    1
        Platelet count decreased - grade 1
    7
        Platelet count decreased - grade 0
    36
        White blood cell decreased - grade 4
    2
        White blood cell decreased - grade 3
    5
        White blood cell decreased - grade 2
    12
        White blood cell decreased - grade 1
    13
        White blood cell decreased - grade 0
    12
        Lymphocyte count decreased - grade 4
    1
        Lymphocyte count decreased - grade 3
    9
        Lymphocyte count decreased - grade 2
    15
        Lymphocyte count decreased - grade 1
    8
        Lymphocyte count decreased - grade 0
    11
        Neutrophil count decreased - grade 4
    3
        Neutrophil count decreased - grade 3
    6
        Neutrophil count decreased - grade 2
    8
        Neutrophil count decreased - grade 1
    4
        Neutrophil count decreased - grade 0
    23
    No statistical analyses for this end point

    Primary: Number of subjects with a shift in laboratory values (Chemistry) from baseline to worst toxicity grade during treatment

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    End point title
    		 Number of subjects with a shift in laboratory values (Chemistry) from baseline to worst toxicity grade during treatment [7]
    End point description
    Changes in laboratory values (Chemistry) as defined by maximum CTCAE toxicity grade during study treatment (Grade 0 = within normal levels, Grade 1 = Mild, 2 = moderate, 3 severe, 4 = life threatening; 5 =death related to AE)
    End point type
    Primary
    End point timeframe
    From baseline to final study visit
    Notes
    [7] - 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 quantitative statistical analysis was performed for this end point.
    End point values
    		 Oraxol
    Number of subjects analysed
    44
    Units: Subjects
        Hyperkalemia-grade 2
    5
        Hyperkalemia-grade 1
    2
        Hyperkalemia-grade 0
    37
        Hypokalemia-grade 3
    1
        Hypokalemia-grade 1
    2
        Hypokalemia-grade 0
    41
        Hypernatremia-grade 1
    4
        Hypernatremia-grade 0
    40
        Hyponatremia-grade 3
    2
        Hyponatremia-grade 1
    6
        Hyponatremia-grade 0
    36
        Alanine aminotransferase increased-grade 1
    17
        Alanine aminotransferase increased-grade 0
    27
        Alkaline phosphatase increased-grade 3
    1
        Alkaline phosphatase increased-grade 2
    4
        Alkaline phosphatase increased-grade 1
    13
        Alkaline phosphatase increased-grade 0
    26
        Aspartate aminotransferase increased-grade 2
    2
        Aspartate aminotransferase increased-grade 1
    14
        Aspartate aminotransferase increased-grade 0
    26
        Gamma-glutamyl transferase (GGT) increased-grade 3
    9
        Gamma-glutamyl transferase (GGT) increased-grade 2
    2
        Gamma-glutamyl transferase (GGT) increased-grade 1
    15
        Gamma-glutamyl transferase (GGT) increased-grade 0
    18
        Blood bilirubin increased-grade 2
    1
        Blood bilirubin increased-grade 1
    1
        Blood bilirubin increased-grade 0
    42
        Creatinine increased-grade 2
    1
        Creatinine increased-grade 1
    35
        Creatinine increased-grade 0
    8
        Hypoalbuminemia-grade 3
    1
        Hypoalbuminemia-grade 2
    10
        Hypoalbuminemia-grade 1
    11
        Hypoalbuminemia-grade 0
    22
        Hypercalcemia-grade 1
    3
        Hypercalcemia-grade 0
    38
        Cholesterol high-grade 2
    1
        Cholesterol high-grade 1
    32
        Cholesterol high-grade 0
    11
        Hyperglycemia-grade 3
    2
        Hyperglycemia-grade 2
    4
        Hyperglycemia-grade 1
    14
        Hyperglycemia-grade 0
    24
        Hypoglycemia-grade 2
    2
        Hypoglycemia-grade 1
    2
        Hypoglycemia-grade 0
    40
        Hypertriglyceridemia-grade 2
    3
        Hypertriglyceridemia-grade 1
    26
        Hypertriglyceridemia-grade 0
    15
        Hyperuricemia-grade 4
    1
        Hyperuricemia-grade 1
    8
        Hyperuricemia-grade 0
    34
        Hypocalcemia-grade 2
    1
        Hypocalcemia-grade 1
    13
        Hypocalcemia-grade 0
    27
    No statistical analyses for this end point

    Secondary: To Evaluate the Plasma Pharmacokinetics of Oral Paclitaxel capsules (Cmax)

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    End point title
    		 To Evaluate the Plasma Pharmacokinetics of Oral Paclitaxel capsules (Cmax)
    End point description
    Cmax (0-24h): Maximum observed plasma concentration (Cmax) of paclitaxel -between Day 1 and Day 2 dosing Cmax (24-48h): Cmax of paclitaxel between Day 2 and Day 3 dosing Cmax (48-56 h): Cmax of paclitaxel after Day 3 dosing
    End point type
    Secondary
    End point timeframe
    Cmax (0-24h): 24 hours after administration of study drug Cmax (24-48h): 24 - 48 hours after administration of study drug Cmax (48-56 h): 48 to 56 hours following administration of study drug
    End point values
    		 Oraxol
    Number of subjects analysed
    37
    Units: nanogram(s)/millilitre
    arithmetic mean (standard deviation)
        Cmax(0-24h)
    265.8 ( 108.0 )
        Cmax(24-48h)
    228.9 ( 104.3 )
        Cmax(48-56h)
    256.9 ( 130.4 )
    No statistical analyses for this end point

    Secondary: To Evaluate the Plasma Pharmacokinetics of Oral Paclitaxel capsules (AUC0-t))

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    End point title
    		 To Evaluate the Plasma Pharmacokinetics of Oral Paclitaxel capsules (AUC0-t))
    End point description
    Area under the concentration × time curve from time 0 to the last determined concentration-time point
    End point type
    Secondary
    End point timeframe
    Predose to the last determined concentration-time point
    End point values
    		 Oraxol
    Number of subjects analysed
    37
    Units: ng•h/mL
        arithmetic mean (standard deviation)
    2963.9 ( 964.4 )
    No statistical analyses for this end point

    Secondary: To Evaluate the Plasma Pharmacokinetics of Oral Paclitaxel capsules (Tmax)

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    End point title
    		 To Evaluate the Plasma Pharmacokinetics of Oral Paclitaxel capsules (Tmax)
    End point description
    Tmax (0-24 h): Time to reach maximum plasma concentration (Tmax) of paclitaxel -between Day 1 and Day 2 dosing Tmax (24-48 h): Tmax of paclitaxel between Day 2 and Day 3 dosing Tmax (48-56 h): Tmax of paclitaxel after Day 3 dosing
    End point type
    Secondary
    End point timeframe
    Tmax (0-24 h): 24 hours after administration of study drug Tmax (24-48 h): 24 to 48 hours after administration of study drug Tmax (48-56 h): 48 to 56 hours following administration of study drug
    End point values
    		 Oraxol
    Number of subjects analysed
    37
    Units: hour
    arithmetic mean (standard deviation)
        Tmax (0-24 h)
    1.6 ( 0.9 )
        Tmax (24-48 h)
    25.6 ( 0.8 )
        Tmax (48-56 h)
    49.4 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Comparison of PK parameters of oral paclitaxel capsules at Week 4 (or later) from this study versus Week 1 in Study KX-ORAX-002 (rollover participants)

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    End point title
    		 Comparison of PK parameters of oral paclitaxel capsules at Week 4 (or later) from this study versus Week 1 in Study KX-ORAX-002 (rollover participants)
    End point description
    PK parameters of oral paclitaxel capsules at Week 4 (or later) from Study KX-ORAX-003 versus Week 1 in Study KX-ORAX-002 were compared in PK Analysis Set participants who also had PK data from the KX-ORAX-002 Study
    End point type
    Secondary
    End point timeframe
    Equivalence of paclitaxel PK parameters administered as Oraxol at Week 4 (or later) (KX-ORAX-003) and Week 1 (KX-ORAX-002)
    End point values
    		 Oraxol
    Number of subjects analysed
    16
    Units: ratio
    geometric mean (confidence interval 90%)
        Cmax
    78.7 (73.0 to 84.9)
        Ctrough24
    99.3 (83.5 to 118.1)
        Ctrough48
    96.4 (82.4 to 112.9)
        AUC0-t
    87.6 (83.0 to 92.7)
    No statistical analyses for this end point

    Secondary: Comparison of PK parameters of paclitaxel tablet and capsule formulations following oral administration

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    End point title
    		 Comparison of PK parameters of paclitaxel tablet and capsule formulations following oral administration
    End point description
    PK parameters of oral paclitaxel tablets versus oral paclitaxel capsules were compared in Group B participants
    End point type
    Secondary
    End point timeframe
    First PK Period at Week 4 (or later) for paclitaxel capsules and for the Second PK Period at Week 5 (or later) for paclitaxel tablets
    End point values
    		 Oraxol (Group B)
    Number of subjects analysed
    9
    Units: ratio
    geometric mean (confidence interval 90%)
        AUC0-t
    179.7 (135.3 to 234.5)
        Cmax
    185.8 (132.0 to 261.5)
        Ctrough24
    124.7 (107.4 to 144.7)
        Ctrough48
    164.6 (137.2 to 197.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of informed consent form (ICF) to final study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Oraxol
    Reporting group description
    		 -

    Serious adverse events
    		 Oraxol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 44 (31.82%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Radiation pneumonitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Brain oedema
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Mucosal inflammation
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
    Additional description: The SAE of pneumonia was considered by the Investigator as unlikely to be related to study treatment; however, the Sponsor considered the event to be possibly related to study treatment.
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
    Additional description: The SAE of septic shock was considered by the Investigator to be associated with disease progression, and unlikely to be related to study treatment; however, the Sponsor considered the event to be possibly related to study treatment.
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Skin infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Oraxol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 44 (97.73%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Flushing
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    7 / 44 (15.91%)
         occurrences all number
    7
    Chest pain
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Influenza like illness
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Axillary pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    14 / 44 (31.82%)
         occurrences all number
    14
    Mucosal inflammation
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Uterine prolapse
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 44 (18.18%)
         occurrences all number
    8
    Epistaxis
         subjects affected / exposed
    7 / 44 (15.91%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Dysphonia
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Oropharyngeal pain
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Nasal inflammation
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Rhinorrhoea
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Haemoptysis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Hypoxia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nasal mucosal disorder
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nasal oedema
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Pneumonitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Sputum increased
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Agitation
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Sleep disorder
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    7 / 44 (15.91%)
         occurrences all number
    7
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    White blood cell count decreased
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Weight decreased
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Breath sounds abnormal
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Anal injury
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Concussion
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Face injury
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Ligament sprain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Muscle strain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Skin injury
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Spinal fracture
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Wound
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Wound complication
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Cardiac disorders
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Headache
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Paraesthesia
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Axonal neuropathy
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Hemiparesis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Hyperaesthesia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nerve compression
    Additional description: Nerve root compression
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Numb chin syndrome
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Parosmia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Neuropathy peripheral
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    5
    Brain oedema
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    7 / 44 (15.91%)
         occurrences all number
    7
    Coagulopathy
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Lymphopenia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Diplopia
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Ocular hyperaemia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Visual impairment
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    27 / 44 (61.36%)
         occurrences all number
    27
    Nausea
         subjects affected / exposed
    23 / 44 (52.27%)
         occurrences all number
    23
    Constipation
         subjects affected / exposed
    9 / 44 (20.45%)
         occurrences all number
    9
    Vomiting
         subjects affected / exposed
    17 / 44 (38.64%)
         occurrences all number
    17
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    5
    Abdominal pain
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Dyspepsia
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Flatulence
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Toothache
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Abdominal discomfort
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Abdominal distension
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Abdominal pain upper
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Dysphagia
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Gastritis
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Stomatitis
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Ascites
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Lip dry
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Oesophageal ulcer
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Tongue ulceration
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    14 / 44 (31.82%)
         occurrences all number
    14
    Onychomadesis
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Nail disorder
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Rash
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Dry skin
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Eczema asteatotic
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Madarosis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nail bed tenderness
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nail growth abnormal
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nail hypertrophy
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nail ridging
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Onychalgia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Pain of skin
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Rash macular
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Rash pruritic
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Skin sensitisation
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Haematuria
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nocturia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Proteinuria
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    6 / 44 (13.64%)
         occurrences all number
    6
    Musculoskeletal chest pain
         subjects affected / exposed
    5 / 44 (11.36%)
         occurrences all number
    5
    Muscular weakness
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Pain in extremity
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Arthralgia
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Bone pain
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Neck pain
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Groin pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Osteitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Infections and infestations
    Paronychia
         subjects affected / exposed
    6 / 44 (13.64%)
         occurrences all number
    6
    Oral candidiasis
         subjects affected / exposed
    4 / 44 (9.09%)
         occurrences all number
    4
    Herpes zoster
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 44 (6.82%)
         occurrences all number
    3
    Cellulitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    2 / 44 (4.55%)
         occurrences all number
    2
    Bacterial vaginosis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Folliculitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Gingivitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Herpes virus infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Hordeolum
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Nail infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Uterine infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Tooth infection
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 44 (20.45%)
         occurrences all number
    9
    Dehydration
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Fluid retention
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Hypernatraemia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 44 (2.27%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jan 2016
    Protocol Amendment Number 1: Added dosing instructions following unacceptable toxicity as well as if body weight changed ≥10% or in the case of missing dose(s) Added instructions regarding management of nausea/vomiting and directions if vomiting occurred within 4 hours postdose on PK sampling days Increased thresholds for hemoglobin (from ≥9 g/L to ≥100 g/L) and ANC (from ≥1.0 × 10*9/L to ≥1.5 × 10*9/L) eligibility criteria demonstrating adequate hematological status at Screening/Baseline Added warfarin as well as strong inducers of CYP3A4 and CYP2C8 as prohibited concomitant medications Added instructions for management of clinically significant ECG abnormality
    20 Apr 2017
    Protocol Amendment Number 2: Added subgroup of participants (i.e., Group B) to determine the bioavailability of paclitaxel tablets versus paclitaxel capsules Added allowance of pre-emptive PICC line placement Added eligibility criteria to allow for when ALP >5 × ULN at Screening/Baseline if liver or bone metastasis were present and the major fraction of ALP was from bone metastasis, at the discretion of the Investigator Allowed for reduced frequency of ECG assessments after Week 4 Added strong inhibitors and strong inducers of P-gp as prohibited concomitant medications
    10 Jul 2017
    Protocol Amendment Number 3: Added threshold for GGT (<10 × ULN) eligibility criteria demonstrating adequate liver function at Screening/Baseline Reduced the frequency of laboratory testing after Week 48 from weekly to every 3 weeks per Investigator discretion unless otherwise indicated
    19 Nov 2017
    Protocol Amendment Number 4: Reduced threshold for hemoglobin (from ≥100 g/L to ≥90 g/L) eligibility criteria demonstrating adequate hematological status at Screening/Baseline Provided that the study may be conducted internationally
    31 Jul 2018
    Protocol Amendment Number 6: Prolonged duration of contraception use after the last dose of study drug

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

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