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    Clinical Trial Results:
    A Phase 2, Randomized, Open-label, 3-arm Study of Relacorilant in Combination with Nab-Paclitaxel for Patients with Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

    Summary
    EudraCT number
    		 2018-004186-14
    Trial protocol
    		 BE   ES   IT  
    Global end of trial date
    12 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jan 2026
    First version publication date
    23 Jan 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CORT125134-552
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03776812
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Corcept Therapeutics
    Sponsor organisation address
    101 Redwood Shores Parkway, Redwood City, United States, 94065
    Public contact
    Corcept Therapeutics, Medical Director, +1 650-327-3270, info@corcept.com
    Scientific contact
    Corcept Therapeutics, Medical Director, +1 650-327-3270, info@corcept.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
    12 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The goal of this study is to evaluate the efficacy of relacorilant either administered daily (continuous) or on the day prior, the day of, and the day after chemotherapy (intermittent) in combination with nab-paclitaxel in the treatment of platinum-resistant ovarian, fallopian tube, or primary peritoneal cancers compared with nab-paclitaxel alone.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Apr 2019
    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
    Spain: 31
    Country: Number of subjects enrolled
    Belgium: 25
    Country: Number of subjects enrolled
    Italy: 49
    Country: Number of subjects enrolled
    United States: 60
    Country: Number of subjects enrolled
    Canada: 13
    Worldwide total number of subjects
    178
    EEA total number of subjects
    105
    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)
    116
    From 65 to 84 years
    62
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subject Disposition is reported for the Intent-to-Treat (ITT) Population: all enrolled and randomized patients.

    Pre-assignment
    Screening details
    		 A total of 178 patients were enrolled in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Continuous Relacorilant Dosing
    Arm description
    		 Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relacorilant
    Investigational medicinal product code
    Other name
    CORT125134
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Relacorilant is supplied as capsules for oral dosing.

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Abraxane
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel is administered as IV infusion over 30-40 minutes.

    Arm title
    		 Arm B: Intermittent Relacorilant Dosing
    Arm description
    		 Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relacorilant
    Investigational medicinal product code
    Other name
    CORT125134
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Relacorilant is supplied as capsules for oral dosing.

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Abraxane
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel is administered as IV infusion over 30-40 minutes.

    Arm title
    		 Arm C: Nab-Paclitaxel Comparator
    Arm description
    		 Patients will receive nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Relacorilant
    Investigational medicinal product code
    Other name
    CORT125134
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Relacorilant is supplied as capsules for oral dosing.

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Abraxane
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel is administered as IV infusion over 30-40 minutes.

    Number of subjects in period 1
    		Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Started
    58
    60
    60
    Entered Crossover
    0
    0
    28
    Completed
    0
    0
    0
    Not completed
    58
    60
    60
         Consent withdrawn by subject
    1
    7
    2
         Did not enter long-term follow-up
    3
    3
    2
         Death
    53
    49
    56
         Lost to follow-up
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Continuous Relacorilant Dosing
    Reporting group description
    		 Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.

    Reporting group title
    Arm B: Intermittent Relacorilant Dosing
    Reporting group description
    		 Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.

    Reporting group title
    Arm C: Nab-Paclitaxel Comparator
    Reporting group description
    		 Patients will receive nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.

    Reporting group values
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator Total
    Number of subjects
    		 58 60 60 178
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 36 38 42 116
        From 65 to 84 years
    		 22 22 18 62
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.6 ( 8.8 ) 60.3 ( 9.7 ) 61.8 ( 8.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 58 60 60 178
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Arm A: Continuous Relacorilant Dosing
    Reporting group description
    		 Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.

    Reporting group title
    Arm B: Intermittent Relacorilant Dosing
    Reporting group description
    		 Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.

    Reporting group title
    Arm C: Nab-Paclitaxel Comparator
    Reporting group description
    		 Patients will receive nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.

    Subject analysis set title
    Crossover Patients
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients initially in the Nab-paclitaxel Comparator Arm (Arm C) who choose to cross over after disease progression will receive relacorilant, 100 mg in combination with nab-paclitaxel, 80 mg/m^2. Relacorilant is supplied as capsules for oral dosing. Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.

    Primary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS)
    End point description
    To assess time from randomization until the date of first documented progressive disease (PD) by RECIST v1.1 (as determined by the Investigator at the local site), or death due to any cause, whichever occurs first. The population analyzed is intent-to-treat (ITT), including all randomized patients.
    End point type
    Primary
    End point timeframe
    Baseline and up to 15 months
    End point values
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Number of subjects analysed
    58
    60
    60
    Units: Months
        median (confidence interval 95%)
    5.29 (3.84 to 5.55)
    5.55 (3.68 to 7.20)
    3.76 (3.52 to 5.36)
    Statistical analysis title
    		 Hazard Ratio: Arm A versus Arm C
    Comparison groups
    Arm A: Continuous Relacorilant Dosing v Arm C: Nab-Paclitaxel Comparator
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3293
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.22
    Statistical analysis title
    		 Hazard Ratio: Arm B versus Arm C
    Comparison groups
    Arm C: Nab-Paclitaxel Comparator v Arm B: Intermittent Relacorilant Dosing
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0384
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 0.98

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    To assess the proportion of patients with measurable disease at Baseline who attain complete response (CR) or partial response (PR) by RECIST v1.1 (confirmation not required). The population analyzed is the ITT population with measurable disease at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 15 months
    End point values
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Number of subjects analysed
    54
    56
    53
    Units: Percentage of patients
        number (not applicable)
    35.19
    35.71
    35.85
    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
    To assess the time from when response (CR or PR) was first documented to the first objectively documented PD or death (whichever occurs first). The population analyzed is the ITT population with measurable disease at Baseline and who attain CR or PR by RECIST v1.1.
    End point type
    Secondary
    End point timeframe
    From first documented response up to 12 months
    End point values
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Number of subjects analysed
    19
    20
    19
    Units: Months
        median (confidence interval 95%)
    3.79 (2.33 to 5.55)
    5.55 (3.75 to 5.88)
    3.65 (2.89 to 5.09)
    No statistical analyses for this end point

    Secondary: Cancer Antigen 125 (CA-125) Response According to Gynecological Cancer Intergroup Criteria (GCIG)

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    End point title
    		 Cancer Antigen 125 (CA-125) Response According to Gynecological Cancer Intergroup Criteria (GCIG)
    End point description
    To assess the overall CA-125 response per GCIG criteria. Response was defined as ≥50% reduction in CA-125 from a pre-treatment sample. Patients whose CA-125 levels fall within the reference range are classified as complete responders. The population analyzed is the ITT population with an initial CA-125 level ≥ twice the upper limit of normal (ULN) of the reference range.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 15 months
    End point values
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Number of subjects analysed
    51
    53
    52
    Units: Percentage of patients
        number (not applicable)
    62.75
    64.15
    53.85
    No statistical analyses for this end point

    Secondary: Best Overall Response (BOR)

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    End point title
    		 Best Overall Response (BOR)
    End point description
    To assess the best response (CR, PR, stable disease [SD], or PD) recorded from the date of randomization until PD/recurrence (or death). The population analyzed is the ITT population with measurable disease at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 15 months
    End point values
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Number of subjects analysed
    54
    56
    53
    Units: Percentage of patients
    number (not applicable)
        Complete response
    7.41
    1.79
    3.77
        Partial response
    27.78
    33.93
    32.08
        Stable disease
    42.59
    35.71
    39.62
        Progressive disease
    16.67
    25
    22.64
        Not evaluable
    5.56
    3.57
    1.89
    No statistical analyses for this end point

    Secondary: PFS Rate at 6 and 12 Months

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    End point title
    		 PFS Rate at 6 and 12 Months
    End point description
    To assess the proportion of patients who have not progressed according to RECIST v1.1 criteria at 6 and 12 months. The population analyzed is the ITT population including all randomized patients. Values are Kaplan-Meijer estimates of the patients who are progression-free at the time points specified.
    End point type
    Secondary
    End point timeframe
    6 and 12 months
    End point values
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Number of subjects analysed
    58
    60
    60
    Units: Proportion of patients
    number (confidence interval 95%)
        6 months
    0.26 (0.15 to 0.38)
    0.40 (0.28 to 0.53)
    0.25 (0.15 to 0.36)
        12 months
    0.08 (0.02 to 0.18)
    0.11 (0.04 to 0.23)
    0.04 (0.01 to 0.12)
    No statistical analyses for this end point

    Secondary: PFS in Patients who Cross Over to Continuous Treatment at Time of Initial PD

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    End point title
    		 PFS in Patients who Cross Over to Continuous Treatment at Time of Initial PD
    End point description
    To assess the time from crossover Baseline (initial PD) until the earliest date of subsequent PD by RECIST v1.1, as determined by the Investigator at the local site, or death from any cause, whichever comes first. The population analyzed is the ITT population initially in Arm C: Nab-paclitaxel Comparator, who choose to cross over after disease progression.
    End point type
    Secondary
    End point timeframe
    Crossover Baseline (Day 50) and up to Day 272
    End point values
    		 Crossover Patients
    Number of subjects analysed
    27
    Units: Months
        median (confidence interval 95%)
    2.10 (1.87 to 2.50)
    No statistical analyses for this end point

    Secondary: ORR in Patients who Cross Over to Continuous Treatment at Time of Initial PD

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    End point title
    		 ORR in Patients who Cross Over to Continuous Treatment at Time of Initial PD
    End point description
    To assess the proportion of patients with measurable disease at the crossover Baseline who attain confirmed CR or PR by RECIST v1.1. The population analyzed is the ITT population initially in Arm C: Nab-paclitaxel Comparator, who choose to cross over after disease progression and have measurable disease at the crossover Baseline.
    End point type
    Secondary
    End point timeframe
    Crossover Baseline (Day 50) and up to Day 272
    End point values
    		 Crossover Patients
    Number of subjects analysed
    21
    Units: Percentage of patients
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: DOR in Patients who Cross Over to Continuous Treatment at Time of Initial PD

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    End point title
    		 DOR in Patients who Cross Over to Continuous Treatment at Time of Initial PD
    End point description
    To assess the time from when the first objective response (CR or PR) in the crossover period to the first objectively documented subsequent PD, or death (whichever occurs first). The population analyzed is the ITT population initially in Arm C: Nab-paclitaxel Comparator, who choose to cross over after disease progression, have measurable disease at the crossover Baseline, and attain CR or PR during the crossover period.
    End point type
    Secondary
    End point timeframe
    From the time of objective response in the crossover period to the time of subsequent PD
    End point values
    		 Crossover Patients
    Number of subjects analysed
    0 [1]
    Units: Months
        median (confidence interval 95%)
    ( to )
    Notes
    [1] - No crossover patients attained CR or PR, so duration of response could not be analyzed.
    No statistical analyses for this end point

    Secondary: BOR in Patients who Cross Over to Continuous Treatment at Time of Initial PD

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    End point title
    		 BOR in Patients who Cross Over to Continuous Treatment at Time of Initial PD
    End point description
    To assess the best overall response (CR, PR, SD, or PD) recorded in the crossover period. The population analyzed is the ITT population initially in Arm C: Nab-paclitaxel Comparator, who choose to cross over after disease progression and have measurable disease at the crossover Baseline.
    End point type
    Secondary
    End point timeframe
    Crossover Baseline (Day 50) and up to Day 272
    End point values
    		 Crossover Patients
    Number of subjects analysed
    21
    Units: Percentage of patients
    number (not applicable)
        Complete response
    0
        Partial response
    0
        Stable disease
    14.29
        Progressive disease
    85.71
        Not evaluable
    0
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    To assess the time from randomization to death by any cause. The population analyzed is the ITT population including all randomized patients.
    End point type
    Secondary
    End point timeframe
    Up to 31 months
    End point values
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Number of subjects analysed
    58
    60
    60
    Units: Months
        median (confidence interval 95%)
    11.30 (7.52 to 16.39)
    13.90 (11.07 to 18.43)
    12.19 (7.72 to 15.28)
    No statistical analyses for this end point

    Secondary: Overall Response According to Combined RECIST v1.1 + GCIG Criteria

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    End point title
    		 Overall Response According to Combined RECIST v1.1 + GCIG Criteria
    End point description
    To assess the proportion of patients with measurable disease at Baseline who attain confirmed CR or PR by RECIST v1.1 and GCIG criteria. GCIG response was defined as ≥50% reduction in CA-125 from a pre-treatment sample. The population analyzed is ITT Population with an initial CA-125 level ≥ twice the ULN of the reference range within 2 weeks before starting treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and up to 15 months
    End point values
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Number of subjects analysed
    58
    60
    60
    Units: Percentage of patients
        number (not applicable)
    58.62
    60
    55
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 39 months
    Adverse event reporting additional description
    The safety population included all randomized patients who received ≥1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Arm A: Continuous Relacorilant Dosing
    Reporting group description
    		 Patients will receive relacorilant 100 mg (titrated up to 150 mg after Cycle 1 or 2) once daily in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.

    Reporting group title
    Arm B: Intermittent Relacorilant Dosing
    Reporting group description
    		 Patients will receive relacorilant 150 mg on the day before (excluding Cycle 1, Day -1), the day of, and the day after nab-paclitaxel, in combination with nab-paclitaxel 80 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.

    Reporting group title
    Arm C: Nab-Paclitaxel Comparator
    Reporting group description
    		 Patients will receive nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle. Patients initially in Arm C who choose to cross over after disease progression will receive relacorilant 100 mg (titrated up to 150 mg) in combination with nab-paclitaxel 80 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle after cross over.

    Serious adverse events
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 57 (52.63%)
    15 / 60 (25.00%)
    19 / 60 (31.67%)
         number of deaths (all causes)
    52
    49
    56
         number of deaths resulting from adverse events
    1
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant pleural effusion
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Gastrointestinal stoma necrosis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stoma prolapse
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Monoparesis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraneoplastic neurological syndrome
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    5 / 57 (8.77%)
    2 / 60 (3.33%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant ascites
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 60 (3.33%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Melanocytic hyperplasia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Biliary tract infection
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Stoma site abscess
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subperiosteal abscess
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial diarrhoea
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A: Continuous Relacorilant Dosing Arm B: Intermittent Relacorilant Dosing Arm C: Nab-Paclitaxel Comparator
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 57 (100.00%)
    59 / 60 (98.33%)
    60 / 60 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 57 (10.53%)
    5 / 60 (8.33%)
    2 / 60 (3.33%)
         occurrences all number
    15
    25
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    24 / 57 (42.11%)
    15 / 60 (25.00%)
    19 / 60 (31.67%)
         occurrences all number
    65
    30
    29
    Fatigue
         subjects affected / exposed
    19 / 57 (33.33%)
    19 / 60 (31.67%)
    21 / 60 (35.00%)
         occurrences all number
    39
    35
    30
    Malaise
         subjects affected / exposed
    5 / 57 (8.77%)
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    5
    1
    2
    Oedema peripheral
         subjects affected / exposed
    8 / 57 (14.04%)
    10 / 60 (16.67%)
    12 / 60 (20.00%)
         occurrences all number
    10
    18
    18
    Peripheral swelling
         subjects affected / exposed
    4 / 57 (7.02%)
    3 / 60 (5.00%)
    3 / 60 (5.00%)
         occurrences all number
    5
    4
    4
    Pyrexia
         subjects affected / exposed
    5 / 57 (8.77%)
    6 / 60 (10.00%)
    10 / 60 (16.67%)
         occurrences all number
    6
    9
    20
    Influenza like illness
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 60 (0.00%)
    0 / 60 (0.00%)
         occurrences all number
    4
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 57 (10.53%)
    9 / 60 (15.00%)
    10 / 60 (16.67%)
         occurrences all number
    10
    12
    12
    Dysphonia
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 60 (1.67%)
    3 / 60 (5.00%)
         occurrences all number
    1
    1
    3
    Dyspnoea
         subjects affected / exposed
    12 / 57 (21.05%)
    4 / 60 (6.67%)
    15 / 60 (25.00%)
         occurrences all number
    15
    11
    26
    Dyspnoea exertional
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 60 (5.00%)
    2 / 60 (3.33%)
         occurrences all number
    3
    4
    4
    Epistaxis
         subjects affected / exposed
    0 / 57 (0.00%)
    5 / 60 (8.33%)
    7 / 60 (11.67%)
         occurrences all number
    0
    6
    8
    Nasal congestion
         subjects affected / exposed
    2 / 57 (3.51%)
    6 / 60 (10.00%)
    2 / 60 (3.33%)
         occurrences all number
    2
    6
    3
    Oropharyngeal pain
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    4
    0
    2
    Pleural effusion
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    7
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 57 (0.00%)
    3 / 60 (5.00%)
    0 / 60 (0.00%)
         occurrences all number
    0
    3
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    4 / 60 (6.67%)
         occurrences all number
    1
    0
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 57 (10.53%)
    4 / 60 (6.67%)
    4 / 60 (6.67%)
         occurrences all number
    7
    4
    4
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 60 (1.67%)
    6 / 60 (10.00%)
         occurrences all number
    5
    1
    13
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 60 (1.67%)
    6 / 60 (10.00%)
         occurrences all number
    5
    1
    15
    Blood alkaline phosphatase increased
         subjects affected / exposed
    5 / 57 (8.77%)
    3 / 60 (5.00%)
    7 / 60 (11.67%)
         occurrences all number
    8
    5
    14
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    2
    0
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 60 (0.00%)
    6 / 60 (10.00%)
         occurrences all number
    7
    0
    8
    Neutrophil count decreased
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 60 (1.67%)
    4 / 60 (6.67%)
         occurrences all number
    3
    2
    4
    Weight decreased
         subjects affected / exposed
    6 / 57 (10.53%)
    3 / 60 (5.00%)
    3 / 60 (5.00%)
         occurrences all number
    7
    3
    6
    White blood cell count decreased
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    5
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    4
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 60 (5.00%)
    1 / 60 (1.67%)
         occurrences all number
    1
    4
    1
    Tachycardia
         subjects affected / exposed
    5 / 57 (8.77%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    6
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 57 (10.53%)
    6 / 60 (10.00%)
    3 / 60 (5.00%)
         occurrences all number
    8
    7
    4
    Dysgeusia
         subjects affected / exposed
    7 / 57 (12.28%)
    7 / 60 (11.67%)
    5 / 60 (8.33%)
         occurrences all number
    7
    7
    6
    Headache
         subjects affected / exposed
    8 / 57 (14.04%)
    7 / 60 (11.67%)
    7 / 60 (11.67%)
         occurrences all number
    10
    8
    7
    Hypoaesthesia
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 60 (3.33%)
    3 / 60 (5.00%)
         occurrences all number
    2
    4
    5
    Neuropathy peripheral
         subjects affected / exposed
    4 / 57 (7.02%)
    3 / 60 (5.00%)
    4 / 60 (6.67%)
         occurrences all number
    5
    5
    10
    Paraesthesia
         subjects affected / exposed
    5 / 57 (8.77%)
    5 / 60 (8.33%)
    7 / 60 (11.67%)
         occurrences all number
    10
    6
    13
    Peripheral sensory neuropathy
         subjects affected / exposed
    26 / 57 (45.61%)
    18 / 60 (30.00%)
    14 / 60 (23.33%)
         occurrences all number
    61
    29
    34
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 60 (5.00%)
    0 / 60 (0.00%)
         occurrences all number
    1
    3
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    39 / 57 (68.42%)
    29 / 60 (48.33%)
    34 / 60 (56.67%)
         occurrences all number
    108
    107
    109
    Leukopenia
         subjects affected / exposed
    7 / 57 (12.28%)
    3 / 60 (5.00%)
    6 / 60 (10.00%)
         occurrences all number
    12
    8
    17
    Neutropenia
         subjects affected / exposed
    20 / 57 (35.09%)
    11 / 60 (18.33%)
    20 / 60 (33.33%)
         occurrences all number
    47
    22
    46
    Thrombocytopenia
         subjects affected / exposed
    7 / 57 (12.28%)
    2 / 60 (3.33%)
    5 / 60 (8.33%)
         occurrences all number
    10
    2
    6
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 60 (1.67%)
    1 / 60 (1.67%)
         occurrences all number
    3
    1
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 60 (5.00%)
    1 / 60 (1.67%)
         occurrences all number
    2
    3
    1
    Lacrimation increased
         subjects affected / exposed
    8 / 57 (14.04%)
    6 / 60 (10.00%)
    2 / 60 (3.33%)
         occurrences all number
    8
    7
    3
    Visual impairment
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 60 (0.00%)
    3 / 60 (5.00%)
         occurrences all number
    5
    0
    3
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 60 (5.00%)
    2 / 60 (3.33%)
         occurrences all number
    3
    4
    5
    Abdominal distension
         subjects affected / exposed
    9 / 57 (15.79%)
    6 / 60 (10.00%)
    4 / 60 (6.67%)
         occurrences all number
    18
    8
    5
    Abdominal pain
         subjects affected / exposed
    21 / 57 (36.84%)
    16 / 60 (26.67%)
    20 / 60 (33.33%)
         occurrences all number
    34
    21
    30
    Abdominal pain lower
         subjects affected / exposed
    0 / 57 (0.00%)
    4 / 60 (6.67%)
    3 / 60 (5.00%)
         occurrences all number
    0
    4
    3
    Abdominal pain upper
         subjects affected / exposed
    7 / 57 (12.28%)
    9 / 60 (15.00%)
    6 / 60 (10.00%)
         occurrences all number
    9
    14
    9
    Ascites
         subjects affected / exposed
    6 / 57 (10.53%)
    5 / 60 (8.33%)
    4 / 60 (6.67%)
         occurrences all number
    9
    7
    7
    Constipation
         subjects affected / exposed
    25 / 57 (43.86%)
    19 / 60 (31.67%)
    17 / 60 (28.33%)
         occurrences all number
    39
    26
    25
    Diarrhoea
         subjects affected / exposed
    22 / 57 (38.60%)
    16 / 60 (26.67%)
    15 / 60 (25.00%)
         occurrences all number
    39
    33
    25
    Dry mouth
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 60 (5.00%)
    2 / 60 (3.33%)
         occurrences all number
    2
    3
    5
    Dyspepsia
         subjects affected / exposed
    7 / 57 (12.28%)
    4 / 60 (6.67%)
    4 / 60 (6.67%)
         occurrences all number
    7
    4
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 60 (0.00%)
    2 / 60 (3.33%)
         occurrences all number
    6
    0
    2
    Intestinal obstruction
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 60 (0.00%)
    4 / 60 (6.67%)
         occurrences all number
    1
    0
    5
    Nausea
         subjects affected / exposed
    41 / 57 (71.93%)
    30 / 60 (50.00%)
    27 / 60 (45.00%)
         occurrences all number
    73
    42
    42
    Stomatitis
         subjects affected / exposed
    15 / 57 (26.32%)
    3 / 60 (5.00%)
    3 / 60 (5.00%)
         occurrences all number
    18
    4
    3
    Vomiting
         subjects affected / exposed
    27 / 57 (47.37%)
    18 / 60 (30.00%)
    15 / 60 (25.00%)
         occurrences all number
    49
    31
    22
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    4
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    21 / 57 (36.84%)
    22 / 60 (36.67%)
    24 / 60 (40.00%)
         occurrences all number
    24
    29
    29
    Dry skin
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 60 (5.00%)
    2 / 60 (3.33%)
         occurrences all number
    8
    3
    2
    Eczema
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    5
    2
    0
    Erythema
         subjects affected / exposed
    2 / 57 (3.51%)
    4 / 60 (6.67%)
    0 / 60 (0.00%)
         occurrences all number
    5
    6
    0
    Nail discolouration
         subjects affected / exposed
    5 / 57 (8.77%)
    5 / 60 (8.33%)
    4 / 60 (6.67%)
         occurrences all number
    9
    6
    4
    Nail disorder
         subjects affected / exposed
    9 / 57 (15.79%)
    4 / 60 (6.67%)
    1 / 60 (1.67%)
         occurrences all number
    20
    4
    1
    Nail dystrophy
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
         occurrences all number
    6
    0
    2
    Nail pigmentation
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 60 (5.00%)
    0 / 60 (0.00%)
         occurrences all number
    3
    3
    0
    Nail ridging
         subjects affected / exposed
    1 / 57 (1.75%)
    4 / 60 (6.67%)
    0 / 60 (0.00%)
         occurrences all number
    1
    4
    0
    Onychalgia
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    5
    1
    0
    Onycholysis
         subjects affected / exposed
    8 / 57 (14.04%)
    6 / 60 (10.00%)
    3 / 60 (5.00%)
         occurrences all number
    14
    6
    4
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    5 / 57 (8.77%)
    3 / 60 (5.00%)
    1 / 60 (1.67%)
         occurrences all number
    7
    7
    1
    Pruritus
         subjects affected / exposed
    4 / 57 (7.02%)
    3 / 60 (5.00%)
    7 / 60 (11.67%)
         occurrences all number
    4
    3
    11
    Rash
         subjects affected / exposed
    11 / 57 (19.30%)
    4 / 60 (6.67%)
    2 / 60 (3.33%)
         occurrences all number
    19
    5
    3
    Skin hyperpigmentation
         subjects affected / exposed
    4 / 57 (7.02%)
    3 / 60 (5.00%)
    1 / 60 (1.67%)
         occurrences all number
    8
    5
    1
    Skin toxicity
         subjects affected / exposed
    5 / 57 (8.77%)
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    7
    1
    3
    Dermatitis acneiform
         subjects affected / exposed
    7 / 57 (12.28%)
    2 / 60 (3.33%)
    1 / 60 (1.67%)
         occurrences all number
    9
    4
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 60 (5.00%)
    4 / 60 (6.67%)
         occurrences all number
    3
    3
    4
    Pollakiuria
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 60 (5.00%)
    4 / 60 (6.67%)
         occurrences all number
    2
    3
    4
    Urinary incontinence
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 60 (1.67%)
    3 / 60 (5.00%)
         occurrences all number
    4
    1
    3
    Hydronephrosis
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
         occurrences all number
    3
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    14 / 57 (24.56%)
    9 / 60 (15.00%)
    7 / 60 (11.67%)
         occurrences all number
    17
    19
    9
    Back pain
         subjects affected / exposed
    10 / 57 (17.54%)
    7 / 60 (11.67%)
    9 / 60 (15.00%)
         occurrences all number
    14
    8
    13
    Bone pain
         subjects affected / exposed
    6 / 57 (10.53%)
    4 / 60 (6.67%)
    6 / 60 (10.00%)
         occurrences all number
    6
    7
    6
    Muscle spasms
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 60 (1.67%)
    8 / 60 (13.33%)
         occurrences all number
    1
    2
    20
    Muscular weakness
         subjects affected / exposed
    3 / 57 (5.26%)
    6 / 60 (10.00%)
    3 / 60 (5.00%)
         occurrences all number
    3
    8
    4
    Myalgia
         subjects affected / exposed
    12 / 57 (21.05%)
    4 / 60 (6.67%)
    10 / 60 (16.67%)
         occurrences all number
    16
    5
    15
    Neck pain
         subjects affected / exposed
    3 / 57 (5.26%)
    4 / 60 (6.67%)
    2 / 60 (3.33%)
         occurrences all number
    3
    5
    2
    Pain in extremity
         subjects affected / exposed
    8 / 57 (14.04%)
    10 / 60 (16.67%)
    8 / 60 (13.33%)
         occurrences all number
    14
    18
    19
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 60 (1.67%)
    3 / 60 (5.00%)
         occurrences all number
    1
    1
    3
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 57 (3.51%)
    1 / 60 (1.67%)
    6 / 60 (10.00%)
         occurrences all number
    2
    1
    8
    Urinary tract infection
         subjects affected / exposed
    8 / 57 (14.04%)
    4 / 60 (6.67%)
    3 / 60 (5.00%)
         occurrences all number
    9
    5
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    20 / 57 (35.09%)
    13 / 60 (21.67%)
    10 / 60 (16.67%)
         occurrences all number
    32
    15
    16
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 60 (5.00%)
    4 / 60 (6.67%)
         occurrences all number
    5
    5
    7
    Hypokalaemia
         subjects affected / exposed
    14 / 57 (24.56%)
    3 / 60 (5.00%)
    5 / 60 (8.33%)
         occurrences all number
    21
    6
    11
    Hypomagnesaemia
         subjects affected / exposed
    9 / 57 (15.79%)
    5 / 60 (8.33%)
    11 / 60 (18.33%)
         occurrences all number
    18
    9
    28
    Hyponatraemia
         subjects affected / exposed
    3 / 57 (5.26%)
    3 / 60 (5.00%)
    2 / 60 (3.33%)
         occurrences all number
    3
    4
    2
    Hypophosphataemia
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 60 (1.67%)
    2 / 60 (3.33%)
         occurrences all number
    5
    2
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2019
    1. Updated Inclusion Criterion 5 to state that CA-125 must be at least twice the upper limit of the reference range or ≥ 70 U/mL. 2. Inclusion Criterion 8 was added: “Appropriate to treat with nab-paclitaxel, in the opinion of the Investigator.” 3. Updated the ORR term overall response rate to objective response rate. The objective response rate did not require a confirmed CR or PR. The BoR rate was removed since it would have been redundant with the objective response rate. 4. Specified that Screening laboratory samples can be used for the Cycle 1 Day 1 visit if taken within 48 hours of the first dose of study treatment. 5. Removed the lead-in visit; procedures that occurred on the first day of dosing were moved to Cycle 1, Day 1. 6. Clarified precautions for administering nab-paclitaxel concomitant medications known to inhibit or induce CYP2C8. 7. Added the option for Arm A and Crossover patients to dose escalate in 25-mg increments per 28-day cycle, after Cycle 1 and 2 only, up to a maximum relacorilant dose of 150 mg once daily. 8. Updated the day for the first dose of relacorilant to Cycle 1, Day 1 in Arms A and B. 9. Clarified pegfilgrastim can be used as prophylactic G-CSF after nab-paclitaxel infusion in patients with a chemotherapy-free window of 2 weeks. 10. Added an objective to assess CA-125 response (by GCIG criteria) and the combined response endpoint based on RECIST v1.1 and GCIG in the Crossover.
    23 Oct 2019
    1. Revised inclusion criteria to include platinum-refractory patients and allow up to 4 prior lines of therapy. 2. Patients discontinuing treatment or completing the study should continue to undergo tumor assessments every 8 weeks until unequivocal PD. Subsequent treatment information will be collected every 8 weeks in patients who are still undergoing radiographic tumor assessments. 3. Investigators must notify the Sponsor within 48 hours if a patient discontinues treatment. 4. After the 30-day follow-up period, any worsening AEs, SAEs related to study treatment, or deaths considered related to study treatment must be recorded. 5. Cranberry was no longer a prohibited food. 6. Added relacorilant 100-mg capsule. 7. Added additional guidance details for reducing and/or delaying nab-paclitaxel and/or relacorilant dose in case of toxicity.

    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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