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    Clinical Trial Results:
    A phase I/II, multicenter, open-label dose finding study of oral CFG920 in patients with metastatic castration-resistant prostate cancer

    Summary
    EudraCT number
    		 2012-001961-33
    Trial protocol
    		 ES   BE  
    Global end of trial date
    03 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2017
    First version publication date
    15 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CFG920X2101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01647789
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Phase I/Dose escalation phase: To estimate the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of oral CFG920 when co administered with prednisone to adult patients with CRPC. Phase II: To assess preliminary antitumor activity of CFG920 across two CRPC groups: Arm 1: Abiraterone acetate (ABI)-naïve Arm 2: ABI resistant
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    31
    EEA total number of subjects
    12
    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)
    9
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study planned to include approximately 24 patients during dose escalation part and at least 50 patients during dose expansion part (with a minimum of 20 patients in arm 1 and 30 in arm 2). Overall, 31 patients were enrolled and treated in dose escalation part (Phase I) of the study, and all of them were analyzed.

    Period 1
    Period 1 title
    Dose Escalation Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CFG920 50mg bid + 5mg prednisone bid
    Arm description
    		 The initial dose of CFG920 was 50 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CFG920
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of CFG920 were supplied to the Investigators at dose strengths of 25 mg and 100 mg. Patients continuously received daily dosing of oral CFG920 capsule.

    Investigational medicinal product name
    prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commercially available prednisone tablets were supplied to the Investigators at dose strengths of 5 mg. Patients continuously received daily dosing of oral CFG920 capsule co-administered with prednisone twice daily for 28 day (4 week) cycles, with no breaks between cycles.

    Arm title
    		 CFG920 100mg bid + 5mg prednisone bid
    Arm description
    		 The dose of CFG920 was 100 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CFG920
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of CFG920 were supplied to the Investigators at dose strengths of 25 mg and 100 mg. Patients continuously received daily dosing of oral CFG920 capsule.

    Investigational medicinal product name
    prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commercially available prednisone tablets were supplied to the Investigators at dose strengths of 5 mg. Patients continuously received daily dosing of oral CFG920 capsule co-administered with prednisone twice daily for 28 day (4 week) cycles, with no breaks between cycles.

    Arm title
    		 CFG920 150mg bid + 5mg prednisone bid
    Arm description
    		 The initial dose of CFG920 was 150 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CFG920
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of CFG920 were supplied to the Investigators at dose strengths of 25 mg and 100 mg. Patients continuously received daily dosing of oral CFG920 capsule.

    Investigational medicinal product name
    prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commercially available prednisone tablets were supplied to the Investigators at dose strengths of 5 mg. Patients continuously received daily dosing of oral CFG920 capsule co-administered with prednisone twice daily for 28 day (4 week) cycles, with no breaks between cycles.

    Arm title
    		 CFG920 200mg bid + 5mg prednisone bid
    Arm description
    		 The initial dose of CFG920 was 150 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CFG920
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules of CFG920 were supplied to the Investigators at dose strengths of 25 mg and 100 mg. Patients continuously received daily dosing of oral CFG920 capsule.

    Investigational medicinal product name
    prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Commercially available prednisone tablets were supplied to the Investigators at dose strengths of 5 mg. Patients continuously received daily dosing of oral CFG920 capsule co-administered with prednisone twice daily for 28 day (4 week) cycles, with no breaks between cycles.

    Number of subjects in period 1
    		CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Started
    6
    9
    6
    10
    Completed
    0
    0
    0
    0
    Not completed
    6
    9
    6
    10
         Adverse event, non-fatal
    -
    2
    2
    3
         disease progression
    6
    7
    4
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CFG920 50mg bid + 5mg prednisone bid
    Reporting group description
    		 The initial dose of CFG920 was 50 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.

    Reporting group title
    CFG920 100mg bid + 5mg prednisone bid
    Reporting group description
    		 The dose of CFG920 was 100 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.

    Reporting group title
    CFG920 150mg bid + 5mg prednisone bid
    Reporting group description
    		 The initial dose of CFG920 was 150 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.

    Reporting group title
    CFG920 200mg bid + 5mg prednisone bid
    Reporting group description
    		 The initial dose of CFG920 was 150 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.

    Reporting group values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid Total
    Number of subjects
    		 6 9 6 10 31
    Age categorical
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.3 ( 4.84 ) 67.1 ( 8.81 ) 68.8 ( 6.85 ) 67.6 ( 7.26 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0 0
        Male
    		 6 9 6 10 31

    End points

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    End points reporting groups
    Reporting group title
    CFG920 50mg bid + 5mg prednisone bid
    Reporting group description
    		 The initial dose of CFG920 was 50 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.

    Reporting group title
    CFG920 100mg bid + 5mg prednisone bid
    Reporting group description
    		 The dose of CFG920 was 100 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.

    Reporting group title
    CFG920 150mg bid + 5mg prednisone bid
    Reporting group description
    		 The initial dose of CFG920 was 150 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.

    Reporting group title
    CFG920 200mg bid + 5mg prednisone bid
    Reporting group description
    		 The initial dose of CFG920 was 150 mg bid co-administered with 5 mg bid of prednisone for 28 day cycles. Dose escalation continued until the MTD/RP2D was estimated.

    Primary: Determination of MTD/RP2D of CFG920 by DLTs occurring in first cycle

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    End point title
    		 Determination of MTD/RP2D of CFG920 by DLTs occurring in first cycle [1]
    End point description
    4 dose levels of CFG920 (50 mg bid, 100 mg bid, 150 mg bid, 200 mg bid) were investigated in the dose escalation part of the study. 150 mg bid was excluded from the candidate doses of maximum tolerated dose (MTD)/ recommended phase ll dose (R2PD) as only 4 subjects were eligible for dose determining set (DDS) at this dose level. The RP2D selected was to be either the MTD or a dose below the MTD based on safety & pharmacokinetic/pharmacodynamic considerations. DLTs - dose limiting toxicities: by primary system organ class, preferred term & treatment group per DDS (consisted of all subjects from the safety set who either met the minimum exposure criterion & had sufficient safety evaluations, or had experienced a DLT during cycle 1 .
    End point type
    Primary
    End point timeframe
    Cycle 1 = first 28 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this primary outcome measure.
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    6
    9
    4
    7
    Units: Subjects
        Any primary system class
    0
    1
    1
    1
        Metabolism & nutrition disorders
    0
    1
    1
    1
        Hyperglycaemia
    0
    0
    0
    1
        Hyperkalaemia
    0
    0
    1
    0
        Hyponatraemia
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Summary of Efficacy measured with Prostrate Specific Antigen (PSA)

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    End point title
    		 Summary of Efficacy measured with Prostrate Specific Antigen (PSA)
    End point description
    PSA observed after first dose of CFG920. For patients who discontinued before 12 weeks, the last obtained PSA value was used.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 Weeks
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    6
    9
    5
    10
    Units: Percentage change
    arithmetic mean (standard deviation)
        PSA change at 12 weeks from baseline
    110.5 ( 251.94 )
    41.4 ( 109.85 )
    152.1 ( 146.98 )
    21.9 ( 92.94 )
        Best PSA change from baseline
    -13.6 ( 57.51 )
    35.4 ( 111.97 )
    69.5 ( 90.86 )
    -20.2 ( 56.6 )
    No statistical analyses for this end point

    Secondary: PSA >= 50% reduction at or after 12 weeks

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    End point title
    		 PSA >= 50% reduction at or after 12 weeks
    End point description
    Number of subjects with PSA reduction >= 50% at or after 12 weeks, after first dose of CFG920. For subjects who discontinued before 12 weeks, the last obtained PSA value was used.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 weeks
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    6
    9
    6
    10
    Units: Subjects
        Yes
    1
    2
    1
    4
        No
    5
    7
    4
    6
        Missing
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: PK parameter: Tmax for CFG920

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    End point title
    		 PK parameter: Tmax for CFG920
    End point description
    The time to reach Cmax for CFG920.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 (C1D1), Cycle 1 Day 15 (C1D15), Cycle 2 Day 1 (C2D1)
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    6
    9
    5
    10
    Units: hr
    median (full range (min-max))
        Tmax: C1D1
    0.583 (0.5 to 2)
    1 (0.467 to 3)
    1 (0.5 to 2.07)
    1.06 (0.5 to 2.02)
        Tmax: C1D15
    1.03 (0.5 to 3)
    1 (0.5 to 3.88)
    1 (0.5 to 2.1)
    2 (0.483 to 4)
        Tmax: C2D1
    0.959 (0.5 to 2)
    2 (1.07 to 3)
    1.92 (0.533 to 2)
    1.17 (1 to 2)
    No statistical analyses for this end point

    Secondary: PK parameter Cmax of CFG920

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    End point title
    		 PK parameter Cmax of CFG920
    End point description
    The maximum concentration of CFG920.
    End point type
    Secondary
    End point timeframe
    C1D1, C1D15, C2D1
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    6
    9
    5
    10
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax: C1D1
    677 ( 149 )
    1250 ( 473 )
    1620 ( 435 )
    2480 ( 798 )
        Cmax: C1D15
    468 ( 208 )
    1040 ( 388 )
    1450 ( 692 )
    2850 ( 1230 )
        Cmax: C2D1
    523 ( 126 )
    1110 ( 269 )
    1220 ( 787 )
    1880 ( 874 )
    No statistical analyses for this end point

    Secondary: PK parameter AUCinf of CFG920

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    End point title
    		 PK parameter AUCinf of CFG920
    End point description
    Area under the concentration - time curve from time zero to infinity.
    End point type
    Secondary
    End point timeframe
    C1D1, C1D15, C2D1
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    5
    5
    4
    7
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        AUCinf: C1D1
    4030 ( 1390 )
    11300 ( 6170 )
    20400 ( 12000 )
    21900 ( 9190 )
        AUCinf: C1D15
    995 ( 381 )
    3320 ( 2360 )
    3540 ( 0 )
    6990 ( 474 )
        AUCinf: C2D1
    1430 ( 673 )
    3030 ( 1020 )
    3410 ( 1170 )
    7370 ( 3000 )
    No statistical analyses for this end point

    Secondary: PK parameter AUC0-12h of CFG920

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    End point title
    		 PK parameter AUC0-12h of CFG920
    End point description
    Area under the concentration - time curve from time zero to 12 hours.
    End point type
    Secondary
    End point timeframe
    C1D1, C1D15, C2D1
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    6
    9
    5
    10
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        AUC0-12h: C1D1
    3310 ( 727 )
    8560 ( 2960 )
    11500 ( 5370 )
    17000 ( 5440 )
        AUC0-12h: C1D15
    1760 ( 1560 )
    4170 ( 2410 )
    9080 ( 5970 )
    15300 ( 6440 )
        AUC0-12h: C2D1
    1710 ( 955 )
    5200 ( 2280 )
    6870 ( 6270 )
    10100 ( 7030 )
    No statistical analyses for this end point

    Secondary: PK parameter T1/2 for CFG920

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    End point title
    		 PK parameter T1/2 for CFG920
    End point description
    The half-life for CFG920.
    End point type
    Secondary
    End point timeframe
    C1D1, C1D15, C2D1
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    5
    5
    4
    7
    Units: hr
    arithmetic mean (standard deviation)
        T1/2: C1D1
    3.47 ( 1.92 )
    3.52 ( 1.52 )
    6.98 ( 3.01 )
    4.88 ( 2.14 )
        T1/2: C1D15
    1.27 ( 0.362 )
    1.7 ( 0.525 )
    1.77 ( 0 )
    1.99 ( 0.619 )
        T1/2: C2D1
    1.75 ( 0.679 )
    1.56 ( 0.247 )
    2.2 ( 1.04 )
    2.03 ( 0.765 )
    No statistical analyses for this end point

    Secondary: PK parameter CL/F for CFG920

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    End point title
    		 PK parameter CL/F for CFG920
    End point description
    Apparent total clearance of the drug from plasma after oral administration.
    End point type
    Secondary
    End point timeframe
    C1D1, C1D15, C2D1
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    5
    5
    4
    7
    Units: L/h
    arithmetic mean (standard deviation)
        CL/F: C1D1
    13.6 ( 4.83 )
    10.9 ( 5.21 )
    9.87 ( 6.33 )
    11 ( 5.63 )
        CL/F: C1D15
    56.9 ( 25.4 )
    40.3 ( 19 )
    42.9 ( 0 )
    29.4 ( 2.78 )
        CL/F: C2D1
    40.9 ( 14.8 )
    35.4 ( 11.8 )
    48.1 ( 14.6 )
    30.5 ( 9.28 )
    No statistical analyses for this end point

    Secondary: PK parameter Vz/F for CFG920

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    End point title
    		 PK parameter Vz/F for CFG920
    End point description
    Apparent volume of distribution during terminal phase after non-intravenous administration.
    End point type
    Secondary
    End point timeframe
    C1D1, C1D15, C2D1
    End point values
    		 CFG920 50mg bid + 5mg prednisone bid CFG920 100mg bid + 5mg prednisone bid CFG920 150mg bid + 5mg prednisone bid CFG920 200mg bid + 5mg prednisone bid
    Number of subjects analysed
    5
    5
    4
    7
    Units: Litre
    arithmetic mean (standard deviation)
        Vz/F: C1D1
    61.2 ( 18.3 )
    48.4 ( 15.7 )
    79 ( 19.8 )
    70.1 ( 29.6 )
        Vz/F: C1D15
    96.3 ( 16.5 )
    88.4 ( 26.1 )
    109 ( 0 )
    85.6 ( 34.3 )
        Vz/F: C2D1
    92.2 ( 11.8 )
    85.5 ( 22.7 )
    141 ( 25.7 )
    83.3 ( 18.2 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    CFG920 50 mg BID
    Reporting group description
    		 CFG920 50 mg BID

    Reporting group title
    CFG920 100 mg BID
    Reporting group description
    		 CFG920 100 mg BID

    Reporting group title
    CFG920 150 mg BID
    Reporting group description
    		 CFG920 150 mg BID

    Reporting group title
    CFG920 200 mg BID
    Reporting group description
    		 CFG920 200 mg BID

    Serious adverse events
    		 CFG920 50 mg BID CFG920 100 mg BID CFG920 150 mg BID CFG920 200 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    4 / 9 (44.44%)
    2 / 6 (33.33%)
    5 / 10 (50.00%)
         number of deaths (all causes)
    1
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Endocarditis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CFG920 50 mg BID CFG920 100 mg BID CFG920 150 mg BID CFG920 200 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    9 / 9 (100.00%)
    6 / 6 (100.00%)
    10 / 10 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tumour pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Angiopathy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Flushing
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    0
    1
    Fatigue
         subjects affected / exposed
    5 / 6 (83.33%)
    3 / 9 (33.33%)
    3 / 6 (50.00%)
    5 / 10 (50.00%)
         occurrences all number
    6
    3
    3
    5
    Malaise
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    Pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    3 / 10 (30.00%)
         occurrences all number
    1
    0
    1
    3
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    2
    Epistaxis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoxia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Alcohol abuse
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anxiety
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    0
    0
    2
    Confusional state
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    Depression
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    Insomnia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Irritability
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Panic attack
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Tobacco abuse
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 9 (22.22%)
    2 / 6 (33.33%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 9 (33.33%)
    3 / 6 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Blood albumin decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 9 (11.11%)
    4 / 6 (66.67%)
    3 / 10 (30.00%)
         occurrences all number
    1
    3
    5
    3
    Blood bilirubin increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood calcium decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    2
    Blood sodium decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    Blood urea increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    3 / 6 (50.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    3
    2
    Platelet count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    4 / 10 (40.00%)
         occurrences all number
    0
    3
    1
    4
    Protein total decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    0
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Contusion
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    3
    0
    0
    3
    Ligament sprain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    1
    0
    3
    Dysgeusia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Monoparesis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Muscle contractions involuntary
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    3
    Paraesthesia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    2
    Presyncope
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Radiculopathy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Syncope
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 6 (33.33%)
    4 / 9 (44.44%)
    2 / 6 (33.33%)
    3 / 10 (30.00%)
         occurrences all number
    2
    5
    2
    5
    Lymphopenia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 9 (22.22%)
    1 / 6 (16.67%)
    4 / 10 (40.00%)
         occurrences all number
    0
    2
    1
    13
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    Dry eye
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abnormal faeces
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Aphthous ulcer
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 9 (33.33%)
    2 / 6 (33.33%)
    3 / 10 (30.00%)
         occurrences all number
    1
    4
    2
    3
    Diarrhoea
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    4
    2
    0
    5
    Dry mouth
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 9 (22.22%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    1
    1
    Faecal incontinence
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Faeces discoloured
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    4 / 6 (66.67%)
    4 / 9 (44.44%)
    1 / 6 (16.67%)
    3 / 10 (30.00%)
         occurrences all number
    4
    4
    1
    4
    Odynophagia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Steatorrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    3 / 6 (50.00%)
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    4 / 10 (40.00%)
         occurrences all number
    4
    2
    0
    4
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Ingrown hair
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematuria
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary incontinence
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    2 / 10 (20.00%)
         occurrences all number
    2
    1
    1
    3
    Back pain
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 9 (33.33%)
    2 / 6 (33.33%)
    2 / 10 (20.00%)
         occurrences all number
    0
    3
    2
    2
    Bone pain
         subjects affected / exposed
    3 / 6 (50.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    6
    1
    0
    0
    Groin pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 9 (0.00%)
    2 / 6 (33.33%)
    2 / 10 (20.00%)
         occurrences all number
    3
    0
    4
    2
    Muscular weakness
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    0
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    2
    Musculoskeletal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    1
    Myopathy
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    2
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 9 (11.11%)
    1 / 6 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    1
    1
    Viral infection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 9 (22.22%)
    1 / 6 (16.67%)
    2 / 10 (20.00%)
         occurrences all number
    2
    3
    1
    2
    Dehydration
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    3
    Hyperkalaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hypernatraemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 9 (22.22%)
    0 / 6 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    2
    0
    3
    Hypophosphataemia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoproteinaemia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 9 (0.00%)
    1 / 6 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 9 (11.11%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Aug 2012
    Amendment 1 was issued prior to enrollment of patients into the study. The main purpose of this amendment was to incorporate changes that Novartis has agreed to as per the agreement with the U.S. Food and Drug Administration. Eligibility Criteria To better define the eligible patient population, more specific inclusion requirements for prior treatment with docetaxel and ABI were added. Due to plausible mechanistic toxicities, laboratory criteria for potassium were added. To further define the DLT criteria for thrombocytopenia, additional details were included with regard to bleeding. Due to potential for mechanistic toxicities, additional dose modification, toxicity monitoring, and toxicity management guidance were added. To modify dose escalation criteria, the language in the guidelines was revised. Following reviewer recommendation, the starting dose was reduced to 50 mg bid.
    01 Mar 2013
    Amendment 2: To improve site and patient compliance and protocol execution, PD assessment was included as an exploratory endpoint. To address emerging data and to inform future decisions, a change from baseline of 30% decline in PSA was added as a secondary endpoint. To assess genetic abnormalities that were thought to be important in cancer, the collection of tumor biopsy specimens was added as an exploratory endpoint. With the addition of the mandatory tumor collection at Screening, receiving any additional tissue was not likely. To address the ensuing limited availability of paired fresh tissue biopsies, the optional fresh pre and post dose biopsies that were to be used to assess the suppression of AR signaling in tumor tissue and potential correlations with clinical outcomes and investigate the change in tumor androgens were eliminated. To allow for a better defining of progression per radiological assessment, the secondary Phase II endpoint to assess efficacy at MTD/RP2D via radiological progression free survival is renamed to radiological time to progression. To assess genetic abnormalities that are thought to be important in cancer, the requirement to collect tumor tissue was added to the inclusion criteria. To prevent premature discontinuation of patients from treatment and thus allowing the continued exploration of higher safe doses of CFG920, the management of blood bilirubin toxicity was revised to be in line with the management of toxicity of other molecules of the same class. To allow for better characterizing toxicity, the use of the adrenocortical insufficiency was changed to mineralocorticoid imbalance. To allow for more frequent assessment of plasma renin activity (PRA), the guidance for the management of adrenocortical insufficiency/ mineralocorticoid imbalance was revised. Because of its potential androgen receptor agonist activity, spironolactone was added as a prohibited medication.
    17 Jul 2013
    Amendment 3: Given the lack of evidence from preclinical studies of a difference in the clinical benefit between these primary and secondary ABI resistant CRPC arms, these two arms were combined into a single ABI resistant CRPC arm (Arm 2) in the Phase II part of the study. A supportive sub-group analysis to further investigate the effect of primary and secondary ABI resistance on CFG920 activity was to be performed retrospectively. Patient numbers were adjusted to match these changes. Because of the potential hyperglycemic effects of prednisone, glucose and HbA1c control (inclusion criteria) and monitoring of glucose levels (DLT and dose modification criteria) were added for patient safety. The DLT criteria were modified to allow for observation of possible hyperglycemia with the control of blood sugar prior to declaration of a DLT. In addition, the dose modification criteria were revised to provide guidance on the management of hyperglycemia as well as the clinical management of the discontinuation of prednisone. Monitoring frequency of PRA was revised to monitor potential changes in plasma renin activity (PRA) within the first five cycles of CFG920 initiation or dose modification. As part of protocol amendment 2, androstenedione was removed from the hormonal assessments. To ensure alignment within the protocol, androstenedione was also removed from the efficacy evaluation section.
    14 Jan 2014
    Amendment 4: In response to the request from Health Authorities, the inclusion criterion for ABI naïve patients in the Phase II part of the study was revised to include patients’ refusal of ABI as follows: no prior treatment with CYP17 inhibitors (ABI, ketoconazole, etc.) or enzalutamide, and refused ABI. Erstwhile data from the ongoing trial indicated that treatment with CFG920 could lead to increased risk of thrombocytopenia. To assess the potential effects of CFG920 on myeloid development, including that of megakaryocytes, the collection of a bone marrow biopsy and aspirate in patients who present with grade 3 or 4 thrombocytopenia was added. The interim analysis evaluated the PSA response, defined as a ≥ 50% reduction in PSA from baseline to ≥ 12 weeks of treatment that was confirmed 4 weeks later. As such, the timing of the interim analysis was revised to be performed after patients had completed at least 16 weeks of treatment.
    28 Oct 2014
    Amendment 6: Introduced a reduced visit schedule to address patients continuing beyond the study data cut off for the primary analysis (15-Aug-2014). Added the date of the data cutoff for the primary clinical study report (CSR). For all efficacy, safety and tolerability, and laboratory evaluation assessments, added the modified collection time points for patients following the reduced visit evaluation schedule. Clarified that the end of treatment collection would not be performed for patients following the reduced visit evaluation schedule. For all efficacy, safety and tolerability, and laboratory evaluation assessments, added the modified collection time points for patients following the reduced visit evaluation schedule.

    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.
    Since patient enrollment was stopped after the completion of the dose-escalation part (Phase I), all analyses related to the phase II part were not conducted. Recruitment halt was implemented after completion of Phase I.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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