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    Clinical Trial Results:
    A Phase 3, Interventional, Double-Blind, Placebo-Controlled study to assess the safety and efficacy of DCC-2618 in Patients with Advanced Gastrointestinal Stromal Tumors who have received treatment with Prior Anticancer Therapies

    Summary
    EudraCT number
    		 2017-002446-76
    Trial protocol
    		 GB   DE   FR   NL   BE   ES   PL   FI   IT  
    Global end of trial date
    11 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2023
    First version publication date
    23 Jun 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DCC-2618-03-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03353653
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Deciphera Pharmaceuticals, LLC
    Sponsor organisation address
    200 Smith Street , Waltham, MA , United States, 02451
    Public contact
    Priyanka Kamath, Deciphera Pharmaceuticals, LLC, 001 7812096400, clinicaltrials@deciphera.com
    Scientific contact
    Priyanka Kamath, Deciphera Pharmaceuticals, LLC, 001 7812096400, clinicaltrials@deciphera.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
    Interim
    Date of interim/final analysis
    13 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the efficacy (progression-free survival [PFS]) of DCC-2618 (ripretinib) by independent radiologic review in patients with advanced gastrointestinal stromal tumors (GIST) who have received prior therapies
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH), Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which the study was conducted All study subjects were required to read and sign an Informed Consent Form Subjects were randomized to either ripretinib (DCC-2618) or placebo and best supportive care in both arms
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jan 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Singapore: 6
    Country: Number of subjects enrolled
    United States: 60
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    129
    EEA total number of subjects
    47
    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)
    79
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 129 participants were enrolled and randomized in the double-blind period in the ITT population. Of the 129 participants randomized in the double-blind period (ITT population), 85 participants were randomized to the ripretinib arm and 44 participants were randomized to the placebo arm. One participant was randomized to placebo but was never treated

    Period 1
    Period 1 title
    Double blind
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ripretinib
    Arm description
    		 DCC-2618 (ripretinib) was supplied as 50 mg strength tablets for oral administration in repeated 28-day cycles. Patients were instructed to take their assigned dose at the same time each day. If a patient dose escalates to 150 mg BID, patients were instructed take the study drug twice a day, at least 6 hours apart, and at the same time each day. On days of scheduled visits, the dose of study drug must be administered at the site after pre-dose assessments have been completed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DCC-2618
    Investigational medicinal product code
    Other name
    Ripretinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DCC-2618 was supplied as 50 mg strength tablets for oral administration. Patients received 150 mg QD or if patient dose escalated 150 mg BID. Patients were instructed to swallow the tablets whole. Tablets must not be crushed, chewed, or dissolved in liquid or food

    Arm title
    		 Placebo
    Arm description
    		 Placebo supplied as identically sized and color-matched tablets
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo supplied as identically sized and color-matched tablets

    Number of subjects in period 1
    		Ripretinib Placebo
    Started
    85
    44
    Completed
    64
    30
    Not completed
    21
    14
         Clinical progression
    4
    3
         termination of study by sponsor
    1
    -
         Physician decision
    1
    1
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    3
    2
         progressive disease by Investigator assessment
    3
    -
         Death
    4
    4
         progressive disease by independent radiologist
    1
    2
         not specified
    1
    -
         Not treated
    -
    1
    Period 2
    Period 2 title
    Open label period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 crossed-over to ripretinib
    Arm description
    		 participants who received placebo in the double-blind period crossed-over to receive ripretinib 150 mg QD in the open-label period
    Arm type
    		 Experimental

    Investigational medicinal product name
    DCC-2618
    Investigational medicinal product code
    Other name
    Ripretinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DCC-2618 was supplied as 50 mg strength tablets for oral administration. Patients received 150 mg QD or if patient dose escalated 150 mg BID. Patients were instructed to swallow the tablets whole. Tablets must not be crushed, chewed, or dissolved in liquid or food

    Arm title
    		 Ripretinib 150 mg QD
    Arm description
    		 Ripretinib 150 mg QD (originally received ripretinib in double-blind period)
    Arm type
    		 Experimental

    Investigational medicinal product name
    DCC-2618
    Investigational medicinal product code
    Other name
    Ripretinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DCC-2618 was supplied as 50 mg strength tablets for oral administration. Patients received 150 mg QD or if patient dose escalated 150 mg BID. Patients were instructed to swallow the tablets whole. Tablets must not be crushed, chewed, or dissolved in liquid or food

    Arm title
    		 Ripretinib 150 mg BID
    Arm description
    		 participants who dose escalated and received ripretinib 150 mg BID in the open-label period
    Arm type
    		 Experimental

    Investigational medicinal product name
    DCC-2618
    Investigational medicinal product code
    Other name
    Ripretinib
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DCC-2618 was supplied as 50 mg strength tablets for oral administration. Patients received 150 mg QD or if patient dose escalated 150 mg BID. Patients were instructed to swallow the tablets whole. Tablets must not be crushed, chewed, or dissolved in liquid or food

    Number of subjects in period 2
    		crossed-over to ripretinib Ripretinib 150 mg QD Ripretinib 150 mg BID
    Started
    30
    18
    62
    Completed
    16
    0
    0
    Not completed
    14
    18
    62
         Clinical progression
    4
    2
    11
         termination of study by sponsor
    2
    2
    2
         Consent withdrawn by subject
    2
    3
    3
         Physician decision
    -
    1
    3
         Adverse event, non-fatal
    1
    -
    9
         progressive disease by Investigator assessment
    5
    3
    28
         Death
    -
    1
    3
         progressive disease by independent radiologist
    -
    5
    1
         not specified
    -
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ripretinib
    Reporting group description
    		 DCC-2618 (ripretinib) was supplied as 50 mg strength tablets for oral administration in repeated 28-day cycles. Patients were instructed to take their assigned dose at the same time each day. If a patient dose escalates to 150 mg BID, patients were instructed take the study drug twice a day, at least 6 hours apart, and at the same time each day. On days of scheduled visits, the dose of study drug must be administered at the site after pre-dose assessments have been completed.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo supplied as identically sized and color-matched tablets

    Reporting group values
    		 Ripretinib Placebo Total
    Number of subjects
    		 85 44 129
    Age categorical
    Age at Informed Consent
    Units: Subjects
        Adults (18-64 years)
    		 57 22 79
        85 years and over
    		 28 22 50
    Age continuous
    Age at Informed Consent
    Units: years
        arithmetic mean (standard deviation)
    		 59.1 ( 10.84 ) 62.0 ( 13.50 ) -
    Gender categorical
    Units: Subjects
        Female
    		 38 18 56
        Male
    		 47 26 73
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 4 5 9
        Black or African American
    		 8 2 10
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        White
    		 64 33 97
        Not Reported
    		 8 4 12
        Other
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 76 38 114
        Not Reported
    		 5 5 10
        Unknown
    		 3 1 4
    ECOG Score at Screening
    Units: Subjects
        Score = 0
    		 37 17 54
        Score = 1
    		 40 24 64
        Score = 2
    		 8 3 11
    Number of Prior Systemic Anticancer Treatments
    Units: Subjects
        Number = 3
    		 54 27 81
        Number >= 4
    		 31 17 48
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 169.7 ( 10.38 ) 169.7 ( 11.72 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 73.9 ( 19.02 ) 71.4 ( 18.04 ) -
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 25.6 ( 6.22 ) 24.5 ( 5.08 ) -
    Subject analysis sets

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who signed the informed consent and were randomised.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least 1 dose of study drug.

    Subject analysis set title
    PK Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomised subjects who received at least 1 dose of DCC-2618 and had at least 1 non-missing PK concentration in plasma reported for DCC-2618 or DP-5439.

    Subject analysis set title
    PP Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients in the ITT population who do not have protocol violations that are expected to compromise the efficacy and/or safety assessments.

    Subject analysis sets values
    		 ITT Population Safety Population PK Population PP Population
    Number of subjects
    129
    128
    114
    70
    Age categorical
    Age at Informed Consent
    Units: Subjects
        Adults (18-64 years)
    79
    79
        85 years and over
    50
    49
    Age continuous
    Age at Informed Consent
    Units: years
        arithmetic mean (standard deviation)
    60.1 ( 11.84 )
    60.0 ( 11.78 )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    56
    56
        Male
    73
    72
    Race
    Units: Subjects
        American Indian or Alaska Native
    0
    0
        Asian
    9
    9
        Black or African American
    10
    10
        Native Hawaiian or Other Pacific Islander
    0
    0
        White
    97
    96
        Not Reported
    12
    12
        Other
    1
    1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    1
    1
        Not Hispanic or Latino
    114
    113
        Not Reported
    10
    10
        Unknown
    4
    4
    ECOG Score at Screening
    Units: Subjects
        Score = 0
    54
    54
        Score = 1
    64
    63
        Score = 2
    11
    11
    Number of Prior Systemic Anticancer Treatments
    Units: Subjects
        Number = 3
    81
    81
        Number >= 4
    48
    47
    Height
    Units: cm
        arithmetic mean (standard deviation)
    169.7 ( 10.80 )
    169.7 ( 10.80 )
    ( )
    ( )
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    73.1 ( 18.67 )
    73.1 ( 18.67 )
    ( )
    ( )
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    25.3 ( 5.87 )
    25.3 ( 5.87 )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Ripretinib
    Reporting group description
    		 DCC-2618 (ripretinib) was supplied as 50 mg strength tablets for oral administration in repeated 28-day cycles. Patients were instructed to take their assigned dose at the same time each day. If a patient dose escalates to 150 mg BID, patients were instructed take the study drug twice a day, at least 6 hours apart, and at the same time each day. On days of scheduled visits, the dose of study drug must be administered at the site after pre-dose assessments have been completed.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo supplied as identically sized and color-matched tablets
    Reporting group title
    crossed-over to ripretinib
    Reporting group description
    		 participants who received placebo in the double-blind period crossed-over to receive ripretinib 150 mg QD in the open-label period

    Reporting group title
    Ripretinib 150 mg QD
    Reporting group description
    		 Ripretinib 150 mg QD (originally received ripretinib in double-blind period)

    Reporting group title
    Ripretinib 150 mg BID
    Reporting group description
    		 participants who dose escalated and received ripretinib 150 mg BID in the open-label period

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who signed the informed consent and were randomised.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least 1 dose of study drug.

    Subject analysis set title
    PK Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All randomised subjects who received at least 1 dose of DCC-2618 and had at least 1 non-missing PK concentration in plasma reported for DCC-2618 or DP-5439.

    Subject analysis set title
    PP Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients in the ITT population who do not have protocol violations that are expected to compromise the efficacy and/or safety assessments.

    Primary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    The interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review, or death due to any cause on initially assigned study treatment, whichever comes earlier.
    End point type
    Primary
    End point timeframe
    Double-Blind Treatment Period
    End point values
    		 Ripretinib Placebo
    Number of subjects analysed
    85
    44
    Units: Weeks
        median (confidence interval 95%)
    27.6 (20.0 to 29.9)
    4.1 (4.0 to 7.3)
    Statistical analysis title
    		 Cox Proportional Regression Model
    Comparison groups
    Ripretinib v Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 0.25

    Secondary: Objective Response Rate

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    End point title
    		 Objective Response Rate
    End point description
    The proportion of patients with a confirmed Complete Response or Partial Response based on the independent radiologic review and during the double-blind phase.
    End point type
    Secondary
    End point timeframe
    Double-Blind Treatment Period
    End point values
    		 Ripretinib Placebo
    Number of subjects analysed
    85
    44
    Units: Subjects
        Complete Response
    0
    0
        Partial Response
    8
    0
        Stable Disease (≥ 6 Weeks)
    56
    9
        Progressive Disease
    16
    28
        Not Evaluable
    4
    3
        No Response Assessment
    1
    4
    Statistical analysis title
    		 Difference in ORR
    Comparison groups
    Ripretinib v Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0504
    Method
    		 Fisher exact
    Parameter type
    		 Difference in ORR (%)
    Point estimate
    9.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 17.5

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    The time interval between the date of randomization until the date of death or the date of last follow-up.
    End point type
    Secondary
    End point timeframe
    Double-Blind Treatment Period
    End point values
    		 Ripretinib Placebo
    Number of subjects analysed
    85
    44
    Units: Weeks
        median (confidence interval 95%)
    65.6 (53.6 to 65.6)
    28.6 (17.9 to 50.4)
    Statistical analysis title
    		 Cox Proportional Regression Model
    Comparison groups
    Ripretinib v Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 0.62

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Double-Blind Treatment Period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Ripretinib
    Reporting group description
    		 DCC-2618 (ripretinib) was supplied as 50 mg strength tablets for oral administration in repeated 28-day cycles. Patients were instructed to take their assigned dose at the same time each day. If a patient dose escalates to 150 mg BID, patients were instructed take the study drug twice a day, at least 6 hours apart, and at the same time each day. On days of scheduled visits, the dose of study drug must be administered at the site after pre-dose assessments have been completed.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo supplied as identically sized and color-matched tablets

    Serious adverse events
    		 Ripretinib Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 85 (30.59%)
    19 / 43 (44.19%)
         number of deaths (all causes)
    12
    13
         number of deaths resulting from adverse events
    5
    10
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Embolism
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    3 / 85 (3.53%)
    4 / 43 (9.30%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
         deaths causally related to treatment / all
    1 / 3
    0 / 4
    General physical health deterioration
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 85 (0.00%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Psychiatric disorders
    Hallucinations, mixed
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 85 (3.53%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 85 (4.71%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nausea
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 85 (2.35%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal fistula
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 85 (1.18%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Urinary retention
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Liver abscess
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 85 (1.18%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 85 (1.18%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ripretinib Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 85 (98.82%)
    41 / 43 (95.35%)
    Investigations
    Weight decreased
         subjects affected / exposed
    16 / 85 (18.82%)
    5 / 43 (11.63%)
         occurrences all number
    18
    5
    Blood bilirubin increased
         subjects affected / exposed
    14 / 85 (16.47%)
    0 / 43 (0.00%)
         occurrences all number
    16
    0
    Lipase increased
         subjects affected / exposed
    9 / 85 (10.59%)
    0 / 43 (0.00%)
         occurrences all number
    12
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 85 (7.06%)
    2 / 43 (4.65%)
         occurrences all number
    8
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    6 / 85 (7.06%)
    1 / 43 (2.33%)
         occurrences all number
    8
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    12 / 85 (14.12%)
    2 / 43 (4.65%)
         occurrences all number
    19
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 85 (18.82%)
    2 / 43 (4.65%)
         occurrences all number
    16
    2
    Dizziness
         subjects affected / exposed
    7 / 85 (8.24%)
    3 / 43 (6.98%)
         occurrences all number
    8
    3
    Peripheral sensory neuropathy
         subjects affected / exposed
    6 / 85 (7.06%)
    1 / 43 (2.33%)
         occurrences all number
    6
    1
    Dysgeusia
         subjects affected / exposed
    3 / 85 (3.53%)
    4 / 43 (9.30%)
         occurrences all number
    4
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 85 (12.94%)
    7 / 43 (16.28%)
         occurrences all number
    13
    12
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    36 / 85 (42.35%)
    10 / 43 (23.26%)
         occurrences all number
    47
    12
    Oedema peripheral
         subjects affected / exposed
    14 / 85 (16.47%)
    3 / 43 (6.98%)
         occurrences all number
    14
    4
    Asthenia
         subjects affected / exposed
    11 / 85 (12.94%)
    5 / 43 (11.63%)
         occurrences all number
    14
    6
    Pyrexia
         subjects affected / exposed
    6 / 85 (7.06%)
    2 / 43 (4.65%)
         occurrences all number
    6
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    32 / 85 (37.65%)
    5 / 43 (11.63%)
         occurrences all number
    38
    5
    Constipation
         subjects affected / exposed
    29 / 85 (34.12%)
    8 / 43 (18.60%)
         occurrences all number
    38
    8
    Abdominal pain
         subjects affected / exposed
    28 / 85 (32.94%)
    12 / 43 (27.91%)
         occurrences all number
    31
    14
    Diarrhoea
         subjects affected / exposed
    24 / 85 (28.24%)
    6 / 43 (13.95%)
         occurrences all number
    30
    9
    Vomiting
         subjects affected / exposed
    17 / 85 (20.00%)
    3 / 43 (6.98%)
         occurrences all number
    19
    3
    Abdominal pain upper
         subjects affected / exposed
    8 / 85 (9.41%)
    2 / 43 (4.65%)
         occurrences all number
    11
    2
    Stomatitis
         subjects affected / exposed
    9 / 85 (10.59%)
    0 / 43 (0.00%)
         occurrences all number
    9
    0
    Dyspepsia
         subjects affected / exposed
    7 / 85 (8.24%)
    6 / 43 (13.95%)
         occurrences all number
    8
    7
    Abdominal distension
         subjects affected / exposed
    3 / 85 (3.53%)
    5 / 43 (11.63%)
         occurrences all number
    5
    5
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    10 / 85 (11.76%)
    0 / 43 (0.00%)
         occurrences all number
    13
    0
    Cough
         subjects affected / exposed
    6 / 85 (7.06%)
    1 / 43 (2.33%)
         occurrences all number
    7
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    44 / 85 (51.76%)
    2 / 43 (4.65%)
         occurrences all number
    54
    2
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    18 / 85 (21.18%)
    0 / 43 (0.00%)
         occurrences all number
    23
    0
    Dry skin
         subjects affected / exposed
    11 / 85 (12.94%)
    3 / 43 (6.98%)
         occurrences all number
    11
    3
    Pruritus
         subjects affected / exposed
    9 / 85 (10.59%)
    2 / 43 (4.65%)
         occurrences all number
    9
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    8 / 85 (9.41%)
    6 / 43 (13.95%)
         occurrences all number
    9
    6
    Anxiety
         subjects affected / exposed
    7 / 85 (8.24%)
    4 / 43 (9.30%)
         occurrences all number
    8
    4
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    27 / 85 (31.76%)
    5 / 43 (11.63%)
         occurrences all number
    37
    6
    Arthralgia
         subjects affected / exposed
    15 / 85 (17.65%)
    2 / 43 (4.65%)
         occurrences all number
    23
    2
    Muscle spasms
         subjects affected / exposed
    13 / 85 (15.29%)
    2 / 43 (4.65%)
         occurrences all number
    16
    2
    Back pain
         subjects affected / exposed
    8 / 85 (9.41%)
    2 / 43 (4.65%)
         occurrences all number
    8
    2
    Pain in extremity
         subjects affected / exposed
    8 / 85 (9.41%)
    2 / 43 (4.65%)
         occurrences all number
    9
    2
    Musculoskeletal pain
         subjects affected / exposed
    5 / 85 (5.88%)
    3 / 43 (6.98%)
         occurrences all number
    5
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    23 / 85 (27.06%)
    9 / 43 (20.93%)
         occurrences all number
    30
    9
    Hypophosphataemia
         subjects affected / exposed
    8 / 85 (9.41%)
    0 / 43 (0.00%)
         occurrences all number
    12
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Nov 2017
    Incorporate changes suggested by the US FDA
    01 Mar 2018
    Updates and clarifications to assessments and dosing schedule, and sample collection. Revision of inclusion/exclusion criteria and guidance on dose escalation
    22 Mar 2018
    Revision of inclusion criteria and clarification on contraception for male patients and concomitant medications
    27 Aug 2018
    Clarifications to inclusion criteria, TEAEs and storage conditions
    30 Oct 2018
    Updates to the statistical analysis for this study
    06 Mar 2020
    Updates to frequency of assessments, collection of samples, and use of concomitant medications for patients who have been on DCC-2618. Clarification to the adverse events section.

    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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