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    Clinical Trial Results:
    A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced Non–Small Cell Lung Cancer With an FGFR Alteration Who Progressed on Previous Therapy (FIGHT-210)

    Summary
    EudraCT number
    		 2021-004934-12
    Trial protocol
    		 IT   ES  
    Global end of trial date
    16 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jul 2024
    First version publication date
    26 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 54828-210
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff Drive, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.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
    16 Aug 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study was conducted to study the safety, efficacy, and tolerability of pemigatinib when used on participants with squamous or nonsquamous non–small cell lung cancer (NSCLC) with documented fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) mutations or fusions/rearrangements who had progressed on prior therapies and had no available standard treatment options.
    Protection of trial subjects
    This study was to be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study was being conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Apr 2022
    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
    France: 1
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    8
    EEA total number of subjects
    5
    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)
    6
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study was conducted at 8 study centers in Spain, Italy, France, and the United States.

    Period 1
    Period 1 title
    Overall Study (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
    		 Cohort A: Squamous NSCLC
    Arm description
    		 Participants with squamous non–small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pemigatinib
    Investigational medicinal product code
    INCB054828
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    available as 4.5-, 9-, and 13.5-mg tablets

    Arm title
    		 Cohort B: Nonsquamous NSCLC
    Arm description
    		 Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pemigatinib
    Investigational medicinal product code
    INCB054828
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    available as 4.5-, 9-, and 13.5-mg tablets

    Number of subjects in period 1
    		Cohort A: Squamous NSCLC Cohort B: Nonsquamous NSCLC
    Started
    3
    5
    Completed
    0
    0
    Not completed
    3
    5
         Consent withdrawn by subject
    1
    -
         Death
    1
    4
         Study Terminated by Sponsor
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A: Squamous NSCLC
    Reporting group description
    		 Participants with squamous non–small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported.

    Reporting group title
    Cohort B: Nonsquamous NSCLC
    Reporting group description
    		 Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported.

    Reporting group values
    		 Cohort A: Squamous NSCLC Cohort B: Nonsquamous NSCLC Total
    Number of subjects
    		 3 5 8
    Age Categorical
    Units: participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 1 5 6
        >=65 years
    		 2 0 2
    Sex: Female, Male
    Units: participants
        Female
    		 1 3 4
        Male
    		 2 2 4
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 3 4 7
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 1
        Not Hispanic or Latino
    		 3 3 6
        Unknown or Not Reported
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Cohort A: Squamous NSCLC
    Reporting group description
    		 Participants with squamous non–small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported.

    Reporting group title
    Cohort B: Nonsquamous NSCLC
    Reporting group description
    		 Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported.

    Primary: Objective response rate (ORR) in Cohort A

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    End point title
    		 Objective response rate (ORR) in Cohort A [1]
    End point description
    ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response was determined by an Independent Central Radiology (ICR) review. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Analysis was conducted in members of the Full Analysis Population, comprised of all enrolled participants who received at least 1 dose of pemigatinib. The confidence interval was calculated based on the exact method for binomial distribution.
    End point type
    Primary
    End point timeframe
    up to 267 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: Statistical analysis was not conducted for this endpoint.
    End point values
    		 Cohort A: Squamous NSCLC Cohort B: Nonsquamous NSCLC
    Number of subjects analysed
    3 [2]
    0 [3]
    Units: percentage of participants
        number (confidence interval 95%)
    33.3 (0.84 to 90.57)
    ( to )
    Notes
    [2] - Full Analysis Population
    [3] - Analysis was only conducted in Cohort A.
    No statistical analyses for this end point

    Secondary: ORR in Cohort B

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    End point title
    		 ORR in Cohort B
    End point description
    ORR was defined as the percentage of participants who achieved a CR or PR based on RECIST v1.1. Response was determined by an ICR review. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. The confidence interval was calculated based on the exact method for binomial distribution.
    End point type
    Secondary
    End point timeframe
    up to 80 days
    End point values
    		 Cohort A: Squamous NSCLC Cohort B: Nonsquamous NSCLC
    Number of subjects analysed
    0 [4]
    5 [5]
    Units: percentage of participants
        number (confidence interval 95%)
    ( to )
    0.0 (0.00 to 52.18)
    Notes
    [4] - Analysis was only conducted in Cohort B.
    [5] - Full Analysis Population
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS) in Cohort A

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    End point title
    		 Progression-free survival (PFS) in Cohort A
    End point description
    PFS was defined as the time from the first dose of study treatment until progressive disease (PD) (according to RECIST v1.1 as assessed by an ICR review) or death, whichever occurred first. PD was defined as the progression of a target or non-target lesion or presence of a new lesion. 9999=The upper limit of the confidence interval was not estimable because too few participants had disease progression or died. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
    End point type
    Secondary
    End point timeframe
    up to 267 days
    End point values
    		 Cohort A: Squamous NSCLC Cohort B: Nonsquamous NSCLC
    Number of subjects analysed
    3 [6]
    0 [7]
    Units: months
        median (confidence interval 95%)
    8.31 (5.19 to 9999)
    ( to )
    Notes
    [6] - Full Analysis Population
    [7] - Analysis was only conducted in Cohort A.
    No statistical analyses for this end point

    Secondary: Duration of response (DOR) in Cohort A

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    End point title
    		 Duration of response (DOR) in Cohort A
    End point description
    DOR was defined as the time from the date of the first CR or PR until the date of the first PD (according to RECIST v1.1 as assessed by an ICR review) or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. -9999, 9999=The median and the upper and lower limits of the confidence interval were not estimable because too few participants had disease progression or died. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
    End point type
    Secondary
    End point timeframe
    up to 182 days
    End point values
    		 Cohort A: Squamous NSCLC Cohort B: Nonsquamous NSCLC
    Number of subjects analysed
    1 [8]
    0 [9]
    Units: months
        median (confidence interval 95%)
    9999 (-9999 to 9999)
    ( to )
    Notes
    [8] - Full Analysis Population. Only those participants with a CR or PR were analyzed.
    [9] - Analysis was only conducted in Cohort A.
    No statistical analyses for this end point

    Secondary: Overall survival (OS) in Cohort A

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    End point title
    		 Overall survival (OS) in Cohort A
    End point description
    OS was defined as the time from the first dose of study treatment to death of any cause. 9999=The median and the upper limit of the confidence interval were not estimable because too few participants died. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
    End point type
    Secondary
    End point timeframe
    up to 267 days
    End point values
    		 Cohort A: Squamous NSCLC Cohort B: Nonsquamous NSCLC
    Number of subjects analysed
    3 [10]
    0 [11]
    Units: months
        median (confidence interval 95%)
    9999 (5.19 to 9999)
    ( to )
    Notes
    [10] - Full Analysis Population
    [11] - Analysis was only conducted in Cohort A.
    No statistical analyses for this end point

    Secondary: Number of participants with any treatment-emergent adverse event (TEAE)

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    End point title
    		 Number of participants with any treatment-emergent adverse event (TEAE)
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. Analysis was conducted in members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of pemigatinib.
    End point type
    Secondary
    End point timeframe
    up to 302 days
    End point values
    		 Cohort A: Squamous NSCLC Cohort B: Nonsquamous NSCLC
    Number of subjects analysed
    3 [12]
    5 [13]
    Units: participants
    3
    5
    Notes
    [12] - Safety Population
    [13] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with any treatment-related TEAE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v5.0

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    End point title
    		 Number of participants with any treatment-related TEAE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v5.0
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib. The investigator assessed the relationship between study drug and each occurrence of each AE/serious adverse event.
    End point type
    Secondary
    End point timeframe
    up to 302 days
    End point values
    		 Cohort A: Squamous NSCLC Cohort B: Nonsquamous NSCLC
    Number of subjects analysed
    3 [14]
    5 [15]
    Units: participants
    3
    5
    Notes
    [14] - Safety Population
    [15] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 302 days
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of pemigatinib and within 30 days of the last dose of pemigatinib, have been reported for members of the Safety Population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Cohort A: Squamous NSCLC
    Reporting group description
    		 Participants with squamous non–small cell lung cancer (NSCLC) with known or likely fibroblast growth factor receptor 1, 2, or 3 (FGFR1-3) driver mutations outside the kinase domain or fusions/rearrangements self-administered pemigatinib 13.5 milligrams (mg) (starting dose) as a once daily (QD) oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported.

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    Cohort B: Nonsquamous NSCLC
    Reporting group description
    		 Participants with nonsquamous NSCLC with known or likely FGFR1-3 driver mutations outside the kinase domain or fusions/rearrangements, including participants who had relapsed on prior targeted therapy, self-administered pemigatinib 13.5 mg (starting dose) as a QD oral treatment on a 21-day cycle. Participants took study drug every day on an intermittent dose regimen (2 weeks on treatment, followed by no study drug for 1 week [dose holiday]), until documented disease progression or unacceptable toxicity was reported.

    Serious adverse events
    		 Cohort A: Squamous NSCLC Total Cohort B: Nonsquamous NSCLC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    2 / 5 (40.00%)
         number of deaths (all causes)
    1
    5
    4
         number of deaths resulting from adverse events
    0
    1
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort A: Squamous NSCLC Total Cohort B: Nonsquamous NSCLC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    8 / 8 (100.00%)
    5 / 5 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    3
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    2
    Chills
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Vaccination site pain
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Xerosis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Dyspnoea
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 8 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    2
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Epistaxis
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Haemoptysis
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 8 (25.00%)
    0 / 5 (0.00%)
         occurrences all number
    3
    3
    0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 8 (37.50%)
    2 / 5 (40.00%)
         occurrences all number
    1
    3
    2
    Blood glucose increased
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Amylase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Blood phosphorus increased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Lipase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    2
    Prostatic specific antigen increased
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Somnolence
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Vitreous detachment
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Visual impairment
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Dry mouth
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    2 / 3 (66.67%)
    5 / 8 (62.50%)
    3 / 5 (60.00%)
         occurrences all number
    8
    11
    3
    Anorectal discomfort
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    2
    2
    0
    Epigastric discomfort
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    3
    3
    0
    Gingival bleeding
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Gingival pain
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Glossodynia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 8 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    2
    1
    Stomatitis
         subjects affected / exposed
    2 / 3 (66.67%)
    4 / 8 (50.00%)
    2 / 5 (40.00%)
         occurrences all number
    3
    5
    2
    Toothache
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 8 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    3
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 8 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    1
    2
    1
    Dry skin
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Nail disorder
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 8 (25.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    2
    0
    Nail dystrophy
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Onychalgia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Pustular psoriasis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Rash
         subjects affected / exposed
    2 / 3 (66.67%)
    3 / 8 (37.50%)
    1 / 5 (20.00%)
         occurrences all number
    2
    3
    1
    Skin ulcer haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Renal and urinary disorders
    Nephropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Bone disorder
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Arthralgia
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 8 (25.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Neck pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Spinal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 8 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    3
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Pharyngitis bacterial
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Spinal cord infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    2
    Dehydration
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    5
    5
    Hypercalcaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 8 (37.50%)
    2 / 5 (40.00%)
         occurrences all number
    1
    4
    3
    Hyperphosphataemia
         subjects affected / exposed
    3 / 3 (100.00%)
    6 / 8 (75.00%)
    3 / 5 (60.00%)
         occurrences all number
    4
    8
    4
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Dec 2021
    The primary purpose of the amendment was to implement updates based on feedback from the Food and Drug Administration.

    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
    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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