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    Clinical Trial Results:
    A single arm, open-label, multicenter Phase 2 study of regorafenib in participants who have been treated in a previous Bayer-sponsored regorafenib study (monotherapy or combination treatment) that has reached the primary completion endpoint, or main data analysis, or has been stopped prematurely

    Summary
    EudraCT number
    		 2018-003650-24
    Trial protocol
    		 GB   DE   IT  
    Global end of trial date
    28 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2024
    First version publication date
    06 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY73-4506/20328
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03890731
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    ​Kaiser-Wilhelm-Allee, ​Leverkusen, Germany, D-51368
    Public contact
    ​Therapeutic Area Head, Bayer AG, ​+49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.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
    13 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - The primary purpose of the program was to enable participants, currently receiving regorafenib in a Bayer sponsored clinical trial and assessed by the principal investigator to be benefitting, to continue regorafenib treatment after their respective study has met its primary completion date, or main data analysis, or has been stopped prematurely. - And the documentation of safety
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Apr 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 1
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Japan: 1
    Worldwide total number of subjects
    6
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    4
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in multiple centers located in 5 countries (including Germany, Japan, Italy, United Kingdom, United States), first subject first visit of the study was on 02 APR 2019 and last subject last visit was on 28 FEB 2023.

    Pre-assignment
    Screening details
    		 This was a rollover study designed to enroll participants from ongoing or future feeder studies. Overall, 6 subjects were enrolled and treated in this study.

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

    Arms
    Arm title
    		 Regorafenib
    Arm description
    		 Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BAY73-4506 (Regorafenib, Stivarga)
    Investigational medicinal product code
    Other name
    Tyrosine-kinase inhibitor
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Either 60, 80, 120 or 160 mg once daily for 3 weeks of every 4-week cycle (3 weeks on, 1 week off)

    Number of subjects in period 1
    		Regorafenib
    Started
    6
    Completed
    0
    Not completed
    6
         Adverse event, non-fatal
    4
         Patient's decision
    1
         Progressive disease
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Regorafenib
    Reporting group description
    		 Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.

    Reporting group values
    		 Regorafenib Total
    Number of subjects
    		 6 6
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 2 2
    Age Continuous
    Units: years
        median (full range (min-max))
    		 61 (44 to 71) -
    Gender Categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 3 3
    Ethnicity (NIH/OMB)
    Units: Subjects
        Not Hispanic or Latino
    		 6 6
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 2 2
        White
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Regorafenib
    Reporting group description
    		 Adult patients from completed Bayer-sponsored regorafenib trials who were benefitting from regorafenib treatment.

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who took at least one dose of regorafenib within this rollover study.

    Primary: Number and severity of subjects with adverse events (AEs) and serious AEs (SAEs)

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    End point title
    		 Number and severity of subjects with adverse events (AEs) and serious AEs (SAEs) [1]
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: 1. results in death 2. is life-threatening 3. requires inpatient hospitalization or prolongation of existing hospitalization, etc.,
    End point type
    Primary
    End point timeframe
    Up to 57 months
    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 AEs, more information please refer to AE section.
    End point values
    		 Regorafenib
    Number of subjects analysed
    6 [2]
    Units: Subjects
        Any AE
    6
        - Non-serious
    6
        - Serious
    3
    Notes
    [2] - SAF
    No statistical analyses for this end point

    Primary: Severity (by worst grade) of subjects with adverse events (AEs) and serious AEs (SAEs)

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    End point title
    		 Severity (by worst grade) of subjects with adverse events (AEs) and serious AEs (SAEs) [3]
    End point description
    AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
    End point type
    Primary
    End point timeframe
    Up to 57 months
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for AEs, more information please refer to AE section.
    End point values
    		 Regorafenib
    Number of subjects analysed
    6 [4]
    Units: Subjects
        Worst grade - Grade 1
    0
        Worst grade - Grade 2
    2
        Worst grade - Grade 3
    1
        Worst grade - Grade 4
    3
        Worst grade - Grade 5 (death)
    0
    Notes
    [4] - SAF
    No statistical analyses for this end point

    Primary: Number and severity of subjects with drug-related adverse events (AEs) and serious AEs (SAEs)

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    End point title
    		 Number and severity of subjects with drug-related adverse events (AEs) and serious AEs (SAEs) [5]
    End point description
    A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.
    End point type
    Primary
    End point timeframe
    Up to 57 months
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for AEs, more information please refer to AE section.
    End point values
    		 Regorafenib
    Number of subjects analysed
    6 [6]
    Units: Subjects
        Any drug-related AE
    5
        - Non-serious
    5
        - Serious
    1
    Notes
    [6] - SAF
    No statistical analyses for this end point

    Primary: Severity (by worst grade) of subjects with drug-related adverse events (AEs) and serious AEs (SAEs)

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    End point title
    		 Severity (by worst grade) of subjects with drug-related adverse events (AEs) and serious AEs (SAEs) [7]
    End point description
    A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug. AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
    End point type
    Primary
    End point timeframe
    Up to 57 months
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for AEs, more information please refer to AE section.
    End point values
    		 Regorafenib
    Number of subjects analysed
    6 [8]
    Units: Subjects
        Worst grade - Grade 1
    1
        Worst grade - Grade 2
    3
        Worst grade - Grade 3
    0
        Worst grade - Grade 4
    1
        Worst grade - Grade 5 (death)
    0
    Notes
    [8] - SAF
    No statistical analyses for this end point

    Secondary: Number of subjects with dose modifications

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    End point title
    		 Number of subjects with dose modifications
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 57 months
    End point values
    		 Regorafenib
    Number of subjects analysed
    6 [9]
    Units: Subjects
        Any dose modification
    6
        Interruption/Delay
    2
        Drug Withdrawn
    5
    Notes
    [9] - SAF
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from the signing of the ICF until the safety follow up- visit (up to 35 days after the last study treatment)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Regorafenib
    Reporting group description
    		 Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.

    Serious adverse events
    		 Regorafenib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 6 (50.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    Electrocardiogram change
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Peritonitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Regorafenib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Haemoglobin decreased
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    11
    International normalised ratio increased
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    5
    Nervous system disorders
    Cerebral venous sinus thrombosis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    3
    Eye disorders
    Retinal vein occlusion
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    4
    Hyperkeratosis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    6
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Renal impairment
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Flank pain
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Osteonecrosis of jaw
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    3
    Hyperglycaemia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2018
    Protocol Amendment 1, date 20 NOV 2018 introduced the following important changes: Safety was upgraded to a second primary objective and a respective endpoint was added to the protocol. A respective endpoint was also added for the secondary objective tolerability.

    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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    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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