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    Clinical Trial Results:
    A pilot study to assess the safety, tolerability, dose finding and efficacy ORY-1001 in combination with platinum-etoposide chemotherapy in patients with relapsed, extensive-stage disease small cell lung cancer

    Summary
    EudraCT number
    		 2018-000469-35
    Trial protocol
    		 ES  
    Global end of trial date
    11 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2023
    First version publication date
    12 Jul 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CL03-ORY-1001SCLC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Oryzon Genomics S. A.
    Sponsor organisation address
    Carrer de Sant Ferran, 74, CORNELLA DE LLOBREGAT, Spain, 08940
    Public contact
    Douglas V. Faller, Oryzon Genomics S. A., 34 93 515 13 13, dfaller@oryzon.com
    Scientific contact
    Douglas V. Faller, Oryzon Genomics S. A., 34 93 515 13 13, dfaller@oryzon.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
    15 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the maximum tolerated dose (MTD), schedule and recommended Phase II dose (RP2D) of ORY-1001 in combination with platinum-etoposide based chemotherapy (EP) in patients with relapsed, extensive-stage disease small cell lung cancer (ED SCLC). This will include characterization of ORY-1001 dose-limiting toxicities (DLTs) and overall safety profile in this population.
    Protection of trial subjects
    In accordance with European Union RGPD 2016/679 of 27 April, 2016 the data were processed in accordance with the specifications outlined by the local law to ensure that requirements regarding personal data protection are met. If an external organization processed data on behalf of Oryzon, a contractual procedure was signed between Oryzon and the external organization to ensure compliance with the above-mentioned legislation. If applicable, the participation of patients in this study was reported to the appropriate local data protection agencies, in accordance with European Union RGPD 2016/679 of 27 April 2016 and Country-specific guidelines and laws (Spanish Organic Law 3/2018 of 5 December).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 17 subjects were screened to obtain a total of 14 enrolled patients. Patients were assigned to any of the Cohorts by the Sponsor and the Medical Monitor according to the available data and the recruitment rate.

    Pre-assignment
    Screening details
    		 ICF for pre-screening specific procedures was obtained in order to confirm tumor biomarkers. If biomarkers positive an ICF was obtained before starting the study procedures. A total of 17 patients signed informed consent. Three patients were screening failures and therefore only 14 patients were accrued in the study and started treatment.

    Period 1
    Period 1 title
    Part 1 or dose-finding stage (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1st TREATMENT SCHEME
    Arm description
    		 Dose iadademstat = 60 μg/m2/d. For 4-6 cycles: first week etoposide/platinum + iadademstat; second and third week iadademstat.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iadademstat
    Investigational medicinal product code
    ORY-1001
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    Dose iadademstat = 60 μg/m2/d. For 4-6 cycles: first week etoposide/platinum + iadademstat; second and third week iadademstat.

    Investigational medicinal product name
    Etoposide/platinum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Platinum-etoposide was given per the SmPC

    Arm title
    		 Cohort A
    Arm description
    		 Dose iadademstat = 60 μg/m2/d. Dosing Scheme #1
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iadademstat
    Investigational medicinal product code
    ORY-1001
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    Dose iadademstat = 60 μg/m2/d at second and third cycle week.

    Investigational medicinal product name
    Etoposide/platinum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Platinum-etoposide was given per the SmPC

    Arm title
    		 Cohort B
    Arm description
    		 Dose iadademstat = 60 μg/m2/d. Dosing Scheme #2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iadademstat
    Investigational medicinal product code
    ORY-1001
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    Dose iadademstat = 60 μg/m2/d. For 4-6 cycles: first week etoposide/platinum + iadademstat; first and third cycle week

    Investigational medicinal product name
    Etoposide/platinum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Platinum-etoposide was given per the SmPC

    Arm title
    		 Cohort C
    Arm description
    		 Dose iadademstat = 45 μg/m2/d. Dosing Scheme #3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iadademstat
    Investigational medicinal product code
    ORY-1001
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    Dose iadademstat = 45 μg/m2/d

    Investigational medicinal product name
    Etoposide/platinum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Platinum-etoposide was given per the SmPC

    Arm title
    		 Cohort D
    Arm description
    		 Dose iadademstat = 60 μg/m2/d. Dosing Scheme #4
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iadademstat
    Investigational medicinal product code
    ORY-1001
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    Dose iadademstat = 60 μg/m2/d. For 4-6 cycles: Three weeks treatment.

    Investigational medicinal product name
    Etoposide/platinum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Third week etoposide/platinum. Platinum-etoposide was given per the SmPC

    Arm title
    		 Cohort E
    Arm description
    		 Dose iadademstat = 60 μg/m2/d. Dosing Scheme #5
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iadademstat
    Investigational medicinal product code
    ORY-1001
    Other name
    Pharmaceutical forms
    Oral solution in single-dose container
    Routes of administration
    Oral use
    Dosage and administration details
    From cycle 2 to 4 or 6: first week with etoposide/platinum and G-CSF administered on days 4, 5 and 6, starting the first dose at least 24 hours after the last dose of etoposide; second week iadademstat; no treatment in third week.

    Investigational medicinal product name
    Etoposide/platinum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Platinum-etoposide was given per the SmPC

    Number of subjects in period 1
    		1st TREATMENT SCHEME Cohort A Cohort B Cohort C Cohort D Cohort E
    Started
    4
    2
    1
    1
    3
    3
    Completed
    1
    1
    1
    1
    3
    2
    Not completed
    3
    1
    0
    0
    0
    1
         Adverse event, serious fatal
    1
    -
    -
    -
    -
    1
         Protocol deviation
    2
    1
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1 or dose-finding stage
    Reporting group description
    		 -

    Reporting group values
    		 Part 1 or dose-finding stage Total
    Number of subjects
    		 14 14
    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)
    		 64.79 ( 7.94 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 12 12
    Subject analysis sets

    Subject analysis set title
    Safety Analysis Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who have received at least one dose of any study treatment, whether prematurely withdrawn from the study or not, will be included in the safety analysis. Unless otherwise specified, the safety population will be the default analysis set used for this study.

    Subject analysis set title
    Efficacy Analysis Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients who have met all the selection criteria and have received at least one dose of study treatment. These patients will have at least screening/baseline data and one assessment of the response during the treatment.

    Subject analysis sets values
    		 Safety Analysis Population Efficacy Analysis Population
    Number of subjects
    14
    9
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.79 ( 7.94 )
    64.00 ( 9.55 )
    Gender categorical
    Units: Subjects
        Female
    2
    1
        Male
    12
    8

    End points

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    End points reporting groups
    Reporting group title
    1st TREATMENT SCHEME
    Reporting group description
    		 Dose iadademstat = 60 μg/m2/d. For 4-6 cycles: first week etoposide/platinum + iadademstat; second and third week iadademstat.

    Reporting group title
    Cohort A
    Reporting group description
    		 Dose iadademstat = 60 μg/m2/d. Dosing Scheme #1

    Reporting group title
    Cohort B
    Reporting group description
    		 Dose iadademstat = 60 μg/m2/d. Dosing Scheme #2

    Reporting group title
    Cohort C
    Reporting group description
    		 Dose iadademstat = 45 μg/m2/d. Dosing Scheme #3

    Reporting group title
    Cohort D
    Reporting group description
    		 Dose iadademstat = 60 μg/m2/d. Dosing Scheme #4

    Reporting group title
    Cohort E
    Reporting group description
    		 Dose iadademstat = 60 μg/m2/d. Dosing Scheme #5

    Subject analysis set title
    Safety Analysis Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who have received at least one dose of any study treatment, whether prematurely withdrawn from the study or not, will be included in the safety analysis. Unless otherwise specified, the safety population will be the default analysis set used for this study.

    Subject analysis set title
    Efficacy Analysis Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients who have met all the selection criteria and have received at least one dose of study treatment. These patients will have at least screening/baseline data and one assessment of the response during the treatment.

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    Safety
    End point type
    Primary
    End point timeframe
    From ICF signature to 30 days after last dose study treatment
    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: Categorical variables were described using absolute and relative frequencies. Continuous variables were described using the mean, standard deviation, confidence interval of mean with 95%, median, percentiles 25th and 75th, minimum and maximum, including the total number of valid values.
    End point values
    		 1st TREATMENT SCHEME Cohort A Cohort B Cohort C Cohort D Cohort E Safety Analysis Population
    Number of subjects analysed
    4
    2
    1
    1
    3
    3
    14
    Units: Adverse events
        Total AE
    110
    31
    16
    15
    26
    15
    213
        Total SAE
    1
    1
    0
    0
    5
    2
    9
        Total ADR
    77
    20
    15
    15
    22
    7
    156
        Total SADR
    0
    0
    0
    0
    4
    1
    5
    No statistical analyses for this end point

    Primary: Tolerability

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    End point title
    		 Tolerability [2]
    End point description
    AE considered DLT
    End point type
    Primary
    End point timeframe
    Firts treatment cycle
    Notes
    [2] - 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: Categorical variables were described using absolute and relative frequencies. Continuous variables were described using the mean, standard deviation, confidence interval of mean with 95%, median, percentiles 25th and 75th, minimum and maximum, including the total number of valid values.
    End point values
    		 1st TREATMENT SCHEME Cohort A Cohort B Cohort C Cohort D Cohort E Safety Analysis Population
    Number of subjects analysed
    4
    2
    1
    1
    3
    3
    14
    Units: Number of DLTs
        Total DLT
    1
    0
    1
    0
    0
    0
    2
    No statistical analyses for this end point

    Secondary: Tumor response according to RECIST version 1.1.

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    End point title
    		 Tumor response according to RECIST version 1.1.
    End point description
    The secondary efficacy endpoint of tumor response was assessed by the investigators following treatment with iadademstat and PE.
    End point type
    Secondary
    End point timeframe
    Treatment period
    End point values
    		 Efficacy Analysis Population
    Number of subjects analysed
    9
    Units: Subjects
        Complete Response
    0
        Partial Response
    3
        First response not achieved
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    1st Treatment scheme
    Reporting group description
    		 -

    Reporting group title
    Cohort A
    Reporting group description
    		 -

    Reporting group title
    Cohort B
    Reporting group description
    		 -

    Reporting group title
    Cohort C
    Reporting group description
    		 -

    Reporting group title
    Cohort D
    Reporting group description
    		 -

    Reporting group title
    Cohort E
    Reporting group description
    		 -

    Serious adverse events
    		 1st Treatment scheme Cohort A Cohort B Cohort C Cohort D Cohort E
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
         number of deaths (all causes)
    1
    1
    0
    0
    1
    1
         number of deaths resulting from adverse events
    1
    1
    0
    0
    1
    1
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnea
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 1st Treatment scheme Cohort A Cohort B Cohort C Cohort D Cohort E
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    Investigations
    Platelet count decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 2 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
         occurrences all number
    12
    8
    6
    8
    4
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 2 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    3
    3
    5
    3
    2
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    3 / 4 (75.00%)
    2 / 2 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
         occurrences all number
    9
    4
    3
    4
    3
    2
    Neutropenia
         subjects affected / exposed
    3 / 4 (75.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
         occurrences all number
    9
    0
    0
    0
    2
    1
    Leukopenia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    5
    0
    0
    0
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
         occurrences all number
    9
    0
    0
    0
    2
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 4 (75.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    3 / 3 (100.00%)
         occurrences all number
    7
    1
    0
    0
    0
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    4
    1
    1
    0
    4
    0
    Constipation
         subjects affected / exposed
    3 / 4 (75.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    3
    0
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    3 / 4 (75.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    4
    0
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    5
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 2 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
         occurrences all number
    1
    5
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    2
    1
    1
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2019
    Pre-Screening period, metastatic sample, changes inclusion criteria 2,3 and 4 and exclusion criteria 4 and 5. Discontinuation Reasons, toxicity management of platinum-based treatment exploratory Biomarkers, prophylaxis treatment with Filgrastim, Chemotherapy concentration.
    25 Mar 2019
    Change Part 1 – Finding dose stage: new dosing scheme
    28 May 2019
    Modifications in the v.3.0 protocol due to clarifications request from RA to substantial amendment nº 2 and include urinaltsis weekly.
    15 Jul 2019
    Change Part 1 – Finding dose stage: 2 new Cohorts and include 2 new sites
    01 Oct 2019
    Review scheme of Cohorts D and E and toxicity management. Change principal investigator IOR. Add new site. Cohorts A and B removed

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Mar 2020
    The sponsor decided to close the recruitment due to the slow pace of enrollment on May 2020, but closing was precipitated to February 2020 by the National health emergency situation caused by SARS-COV-2 (COVID-19).
    -

    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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