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    Clinical Trial Results:
    Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Including Patients With MYC Alterations

    Summary
    EudraCT number
    		 2014-004509-34
    Trial protocol
    		 DE   NL   ES   HU   FR  
    Global end of trial date
    28 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2021
    First version publication date
    02 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CUDC-907-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02674750
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Curis, Inc.
    Sponsor organisation address
    128 Spring St. Building C, Suite 500, Lexington, United States, 02421
    Public contact
    Reinhard von Roemeling, Curis, Inc., 617 503 6500,
    Scientific contact
    Reinhard von Roemeling, Curis, Inc., 617 503 6500,
    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
    28 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial was to evaluate the efficacy of CUDC-907 as measured by the objective response rate (ORR) in Group B participants with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL) with MYC-altered disease by IHC.
    Protection of trial subjects
    The study wase conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH, GCP guidelines, applicable regulatory requirements, and Curis policies. The Investigator ensured that this study was conducted in full conformity with the principles set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Patients of Research, as drafted by the U.S. National Commission for the Protection of Human Patients of Biomedical and Behavioral Research (18 April 1979) and codified in 45 Code of Federal Regulations (CFR) Part 46 and/or the ICH E6.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jul 2016
    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: 4
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    United States: 61
    Worldwide total number of subjects
    70
    EEA total number of subjects
    9
    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)
    40
    From 65 to 84 years
    29
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at 16 study centres in the United States, Spain and France.

    Pre-assignment
    Screening details
    		 A screening period of up to 28 days occurred before treatment.

    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
    		 Group A
    Arm description
    		 Participants with MYC translocation+ and/or MYC gene copy number gain by fluorescence in-situ hybridization (FISH).
    Arm type
    		 Experimental

    Investigational medicinal product name
    CUDC-907
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received CUDC-907 in 21-day cycles.

    Arm title
    		 Group B
    Arm description
    		 Participants with MYC expression in ≥ 40% of tumor cells by immunohistochemistry (IHC).
    Arm type
    		 Experimental

    Investigational medicinal product name
    CUDC-907
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received CUDC-907 in 21-day cycles.

    Arm title
    		 Group C
    Arm description
    		 Participants with MYC translocation by FISH, and MYC expression in < 40% of tumor cells, and no MYC gene copy number gain by FISH. Participants who did not meet the criteria for Groups A or B based on central laboratory testing and review were assigned to Group C.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CUDC-907
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received CUDC-907 in 21-day cycles.

    Number of subjects in period 1
    		Group A Group B Group C
    Started
    5
    49
    16
    Completed
    0
    0
    0
    Not completed
    5
    49
    16
         Consent withdrawn by subject
    -
    1
    1
         Death
    4
    32
    8
         Other
    -
    4
    -
         Study Terminated by Sponsor
    -
    4
    4
         Progressive disease
    1
    7
    3
         Lost to follow-up
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Participants with MYC translocation+ and/or MYC gene copy number gain by fluorescence in-situ hybridization (FISH).

    Reporting group title
    Group B
    Reporting group description
    		 Participants with MYC expression in ≥ 40% of tumor cells by immunohistochemistry (IHC).

    Reporting group title
    Group C
    Reporting group description
    		 Participants with MYC translocation by FISH, and MYC expression in < 40% of tumor cells, and no MYC gene copy number gain by FISH. Participants who did not meet the criteria for Groups A or B based on central laboratory testing and review were assigned to Group C.

    Reporting group values
    		 Group A Group B Group C Total
    Number of subjects
    		 5 49 16 70
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.0 ± 7.38 62.9 ± 10.57 63.1 ± 10.25 -
    Gender categorical
    Units: Subjects
        Female
    		 2 20 7 29
        Male
    		 3 29 9 41
    Race
    Units: Subjects
        White
    		 4 44 14 62
        Black or African American
    		 0 3 0 3
        Asian
    		 0 0 1 1
        Other
    		 1 1 1 3
        Missing
    		 0 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 4 1 6
        Not Hispanic or Latino
    		 3 44 14 61
        Not Reported
    		 1 0 0 1
        Unknown
    		 0 1 0 1
        Missing
    		 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Participants with MYC translocation+ and/or MYC gene copy number gain by fluorescence in-situ hybridization (FISH).

    Reporting group title
    Group B
    Reporting group description
    		 Participants with MYC expression in ≥ 40% of tumor cells by immunohistochemistry (IHC).

    Reporting group title
    Group C
    Reporting group description
    		 Participants with MYC translocation by FISH, and MYC expression in < 40% of tumor cells, and no MYC gene copy number gain by FISH. Participants who did not meet the criteria for Groups A or B based on central laboratory testing and review were assigned to Group C.

    Primary: Objective Response Rate (ORR) (Central Determination) in Group B Participants

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    End point title
    		 Objective Response Rate (ORR) (Central Determination) in Group B Participants [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 2 years
    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: The primary endpoint was not analyzed since only data from local radiographic review were available for analysis.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Group B Analysis was planned for this endpoint.
    End point values
    		 Group B
    Number of subjects analysed
    0 [3]
    Units: Number of Participants
    Notes
    [3] - Analysis of ORR in Group B was not performed since central radiographic review was not performed.
    No statistical analyses for this end point

    Secondary: ORR (Local Determination) in Group B Participants

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    End point title
    		 ORR (Local Determination) in Group B Participants [4]
    End point description
    Intent-to-Treat (ITT) Population.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Group B Analysis was planned for this endpoint.
    End point values
    		 Group B
    Number of subjects analysed
    49
    Units: Percentage of Participants
        number (confidence interval 95%)
    14.3 (5.94 to 27.24)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) in Group B Participants

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    End point title
    		 Progression Free Survival (PFS) in Group B Participants [5]
    End point description
    Evaluable Population.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Group B Analysis was planned for this endpoint.
    End point values
    		 Group B
    Number of subjects analysed
    28
    Units: Months
        median (confidence interval 95%)
    2.7 (1.28 to 4.05)
    No statistical analyses for this end point

    Secondary: PFS Status at 6 Months in Group B Participants

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    End point title
    		 PFS Status at 6 Months in Group B Participants [6]
    End point description
    Evaluable Population.
    End point type
    Secondary
    End point timeframe
    6 months
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Group B Analysis was planned for this endpoint.
    End point values
    		 Group B
    Number of subjects analysed
    28
    Units: Number of Participants
        Event
    18
        Censored
    10
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) in Group B Participants

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    End point title
    		 Overall Survival (OS) in Group B Participants [7]
    End point description
    Evaluable Population.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Group B Analysis was planned for this endpoint.
    End point values
    		 Group B
    Number of subjects analysed
    28
    Units: Months
        median (confidence interval 95%)
    6.3 (3.75 to 99999)
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR) (Local Determination) in Group B Participants

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    End point title
    		 Disease Control Rate (DCR) (Local Determination) in Group B Participants [8]
    End point description
    Evaluable Population.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Group B Analysis was planned for this endpoint.
    End point values
    		 Group B
    Number of subjects analysed
    28
    Units: Percentage of Participants
        number (confidence interval 95%)
    46.4 (27.51 to 66.13)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) (Local Determination) in Group B Participants

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    End point title
    		 Duration of Response (DOR) (Local Determination) in Group B Participants [9]
    End point description
    Evaluable Population.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Group B Analysis was planned for this endpoint.
    End point values
    		 Group B
    Number of subjects analysed
    28
    Units: Months
        median (confidence interval 95%)
    2.8 (1.41 to 99999)
    No statistical analyses for this end point

    Secondary: ORR in Group A and Group C Participants

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    End point title
    		 ORR in Group A and Group C Participants [10]
    End point description
    ITT Population.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only Group A and Group C Analyses were planned for this endpoint.
    End point values
    		 Group A Group C
    Number of subjects analysed
    5
    16
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.00 to 52.18)
    6.3 (0.16 to 30.23)
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced an Adverse Event (AE)

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    End point title
    		 Number of Participants who Experienced an Adverse Event (AE)
    End point description
    Safety Population.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    5
    47
    16
    Units: Number of Participants
    5
    47
    16
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced a Serious Adverse Event (SAE)

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    End point title
    		 Number of Participants who Experienced a Serious Adverse Event (SAE)
    End point description
    Safety Population.
    End point type
    Secondary
    End point timeframe
    Up to 2 years
    End point values
    		 Group A Group B Group C
    Number of subjects analysed
    5
    47
    16
    Units: Number of Participants
    0
    22
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 2 years
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Participants with MYC translocation+ and/or MYC gene copy number gain by fluorescence in-situ hybridization (FISH).

    Reporting group title
    Group B
    Reporting group description
    		 Participants with MYC expression in ≥ 40% of tumor cells by immunohistochemistry (IHC).

    Reporting group title
    Group C
    Reporting group description
    		 Participants with MYC translocation by FISH, and MYC expression in < 40% of tumor cells, and no MYC gene copy number gain by FISH. Participants who did not meet the criteria for Groups A or B based on central laboratory testing and review were assigned to Group C.

    Serious adverse events
    		 Group A Group B Group C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    22 / 47 (46.81%)
    8 / 16 (50.00%)
         number of deaths (all causes)
    4
    32
    8
         number of deaths resulting from adverse events
    0
    10
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 5 (0.00%)
    6 / 47 (12.77%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 6
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Tracheal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    3 / 16 (18.75%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Citrobacter bacteraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A Group B Group C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    47 / 47 (100.00%)
    16 / 16 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    1
    Hypertension
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Hot flush
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
    15 / 47 (31.91%)
    8 / 16 (50.00%)
         occurrences all number
    1
    19
    8
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    8 / 47 (17.02%)
    4 / 16 (25.00%)
         occurrences all number
    0
    11
    4
    Oedema peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    6 / 47 (12.77%)
    2 / 16 (12.50%)
         occurrences all number
    0
    8
    3
    Asthenia
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    3
    Chills
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
         occurrences all number
    1
    4
    0
    Mass
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 47 (4.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    0
    Oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Chest pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Malaise
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    9 / 47 (19.15%)
    3 / 16 (18.75%)
         occurrences all number
    0
    15
    3
    Cough
         subjects affected / exposed
    0 / 5 (0.00%)
    9 / 47 (19.15%)
    0 / 16 (0.00%)
         occurrences all number
    0
    9
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    5 / 47 (10.64%)
    1 / 16 (6.25%)
         occurrences all number
    0
    5
    1
    Dysphonia
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Productive cough
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Pneumonitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 47 (8.51%)
    0 / 16 (0.00%)
         occurrences all number
    0
    4
    0
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    6 / 47 (12.77%)
    4 / 16 (25.00%)
         occurrences all number
    0
    20
    7
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    6 / 47 (12.77%)
    3 / 16 (18.75%)
         occurrences all number
    0
    18
    7
    Weight decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    7 / 47 (14.89%)
    1 / 16 (6.25%)
         occurrences all number
    0
    10
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    3 / 16 (18.75%)
         occurrences all number
    0
    2
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    1 / 16 (6.25%)
         occurrences all number
    0
    4
    1
    Brain natriuretic peptide increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Pericardial effusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 5 (0.00%)
    8 / 47 (17.02%)
    3 / 16 (18.75%)
         occurrences all number
    0
    10
    3
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 47 (8.51%)
    2 / 16 (12.50%)
         occurrences all number
    0
    4
    2
    Dysgeusia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    2
    Neuropathy peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Paraesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Ageusia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Parosmia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 5 (20.00%)
    20 / 47 (42.55%)
    7 / 16 (43.75%)
         occurrences all number
    3
    41
    18
    Anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    11 / 47 (23.40%)
    6 / 16 (37.50%)
         occurrences all number
    0
    16
    13
    Neutropenia
         subjects affected / exposed
    2 / 5 (40.00%)
    8 / 47 (17.02%)
    4 / 16 (25.00%)
         occurrences all number
    2
    14
    6
    Leukopenia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 5 (80.00%)
    35 / 47 (74.47%)
    7 / 16 (43.75%)
         occurrences all number
    6
    82
    29
    Nausea
         subjects affected / exposed
    2 / 5 (40.00%)
    25 / 47 (53.19%)
    6 / 16 (37.50%)
         occurrences all number
    2
    31
    8
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    14 / 47 (29.79%)
    5 / 16 (31.25%)
         occurrences all number
    0
    19
    11
    Constipation
         subjects affected / exposed
    1 / 5 (20.00%)
    11 / 47 (23.40%)
    2 / 16 (12.50%)
         occurrences all number
    1
    13
    2
    Abdominal pain
         subjects affected / exposed
    1 / 5 (20.00%)
    5 / 47 (10.64%)
    3 / 16 (18.75%)
         occurrences all number
    1
    7
    4
    Dyspepsia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    3 / 16 (18.75%)
         occurrences all number
    0
    1
    4
    Abdominal pain upper
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Dry mouth
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Dysphagia
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Impaired gastric emptying
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Toothache
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
         occurrences all number
    1
    4
    0
    Alopecia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Rash
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Dry skin
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    3 / 16 (18.75%)
         occurrences all number
    0
    3
    4
    Dysuria
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Urinary tract pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 5 (0.00%)
    7 / 47 (14.89%)
    2 / 16 (12.50%)
         occurrences all number
    0
    12
    2
    Pain in extremity
         subjects affected / exposed
    1 / 5 (20.00%)
    6 / 47 (12.77%)
    1 / 16 (6.25%)
         occurrences all number
    1
    10
    1
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    6 / 47 (12.77%)
    0 / 16 (0.00%)
         occurrences all number
    0
    11
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 47 (8.51%)
    1 / 16 (6.25%)
         occurrences all number
    0
    5
    1
    Myalgia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Bone pain
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 47 (2.13%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Flank pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    5 / 47 (10.64%)
    0 / 16 (0.00%)
         occurrences all number
    0
    6
    0
    Cellulitis
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    2 / 16 (12.50%)
         occurrences all number
    0
    1
    2
    Candida infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 47 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    2 / 5 (40.00%)
    12 / 47 (25.53%)
    9 / 16 (56.25%)
         occurrences all number
    2
    18
    17
    Decreased appetite
         subjects affected / exposed
    2 / 5 (40.00%)
    15 / 47 (31.91%)
    5 / 16 (31.25%)
         occurrences all number
    2
    16
    5
    Hypomagnesaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    6 / 47 (12.77%)
    5 / 16 (31.25%)
         occurrences all number
    1
    15
    11
    Hypophosphataemia
         subjects affected / exposed
    1 / 5 (20.00%)
    5 / 47 (10.64%)
    1 / 16 (6.25%)
         occurrences all number
    2
    12
    5
    Dehydration
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 47 (2.13%)
    4 / 16 (25.00%)
         occurrences all number
    0
    2
    7
    Hypocalcaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 47 (8.51%)
    2 / 16 (12.50%)
         occurrences all number
    0
    10
    3
    Hyperuricaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 47 (8.51%)
    0 / 16 (0.00%)
         occurrences all number
    0
    5
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 47 (4.26%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Hyperglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 47 (6.38%)
    0 / 16 (0.00%)
         occurrences all number
    0
    5
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 47 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2016
    Primary and secondary endpoints, eligibility criteria, and analysis population for the primary endpoint were updated.
    17 Jun 2016
    Eligibility criteria was updated.
    30 Aug 2016
    Study design was changed from Simon Two-stage to single-arm to remove risk of holding study enrollment and to increase the number of subjects that may receive CUDC-907 alone.

    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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