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    Clinical Trial Results:
    A phase II exploratory study of durvalumab (MEDI4736) in HIV-1 patients with advanced solid tumors

    Summary
    EudraCT number
    		 2016-004524-38
    Trial protocol
    		 ES  
    Global end of trial date
    29 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jun 2022
    First version publication date
    06 Jun 2022
    Other versions
    Summary report(s)
    		 GECP_DURVAST_summary final report

    Trial information

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    Trial identification
    Sponsor protocol code
    GECP16/04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03094286
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación GECP
    Sponsor organisation address
    Avda. Merididana 358, Barcelona, Spain, 08027
    Public contact
    Clinical Trial Information section, Fundación GECP (Grupo Español de Cáncer de Pulmón), +34 934302006, epereira@gecp.org
    Scientific contact
    Clinical Trial Information section, Fundación GECP (Grupo Español de Cáncer de Pulmón), +34 934302006, epereira@gecp.org
    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
    12 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the feasibility of durvalumab (MEDI4736) monotherapy at the recommended dose of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2017
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    18
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between May 2017 and July 2018, a total of 33 patients were enrolled in the study from 7 different sites.

    Pre-assignment
    Screening details
    		 Histologically advanced/metatasic lung cancer, head and neck cancer, cervical cancer, melanoma, anal cancer, pancreatic cancer, gastrio-esophageal cancer, triple negative breast cancer, bladder or renal cancer, Cholangiocarcinoma, Kaposi sarcoma, lymphomas, ovarian cancer or Merkel cell carcinoma. HIV infection. Undetectable viral load at last test

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

    Arms
    Arm title
    		 Experimental
    Arm description
    		 Durvalumab 1500 mg IV commences on Day 1 following confirmation of eligibility into the study and continues on a Q4W schedule until confirmed PD (unless the investigator considers the subject to continue to receive benefit from treatment), initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or if other reasons to discontinue study treatment occur.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Medi4736
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Durvalumab, 1500 mg intravenous infusion Q4W durvalumab (equivalent to 20 mg/kg Q4W) if> 30 kg. If patient is ≤30 kg, weight-based dosing, equivalent to 20 mg/kg Q4W, should be used.

    Number of subjects in period 1
    		Experimental
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall study (overall period) Total
    Number of subjects
    		 20 20
    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)
    		 53.50 ± 10.50 -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 16 16
    Race
    Units: Subjects
        Caucasian
    		 19 19
        Other
    		 1 1
    ECOG
    Units: Subjects
        ECOG 0-1
    		 19 19
        ECOG 2
    		 1 1
    Smoking status
    Units: Subjects
        Former smoker
    		 9 9
        Never smoker
    		 2 2
        Smoker
    		 9 9
    No of prior systemic therapies
    Units: Subjects
        None
    		 8 8
        One
    		 4 4
        Equal or major of Two
    		 8 8
    Basal CD4-count cells/mm3
    Units: Subjects
        <200
    		 1 1
        200-350
    		 8 8
        >350
    		 11 11
    Type of Cancer
    Units: Subjects
        Anal
    		 2 2
        Bladder
    		 1 1
        Melanoma
    		 2 2
        NSCLC
    		 14 14
        SCLC
    		 1 1
    LungCancer
    Units: Subjects
        YES
    		 15 15
        NO
    		 5 5
    Lung cancer type
    Units: Subjects
        NSCLC EGFR-, ALK-
    		 14 14
        SCLC
    		 1 1
        Other
    		 5 5
    NSCLC histology
    Units: Subjects
        Adenocarcinoma
    		 8 8
        Squamous
    		 3 3
        NOS/Undifferenciated
    		 3 3
        N/A
    		 6 6
    HIV-1 group transmission
    Units: Subjects
        Heterosexual individuals
    		 6 6
        MSM
    		 6 6
        IDUs
    		 6 6
        Unknown
    		 2 2
    Metastasis by cancer type
    Units: Subjects
        Anal
    		 2 2
        Bladder
    		 1 1
        Melanoma
    		 2 2
        NSCLC
    		 14 14
        SCLC
    		 1 1
    Number of metastatic sites
    Units: Subjects
        One
    		 5 5
        Two
    		 9 9
        Three
    		 4 4
        Five
    		 2 2
    Years since cancer diagnosis
    Units: Years
        arithmetic mean (standard deviation)
    		 1.80 ± 2.80 -
    Years since HIV diagnosis
    Units: year
        arithmetic mean (standard deviation)
    		 17.68 ± 10.18 -
    CD4 at baseline
    Units: cells/mm3
        arithmetic mean (standard deviation)
    		 416.95 ± 181.27 -
    Plasma Viral load at baseline
    Units: copies/mL
        arithmetic mean (standard deviation)
    		 25.39 ± 15.58 -
    Treatment duration
    Units: month
        arithmetic mean (standard deviation)
    		 8.73 ± 11.57 -
    Time on treatment and PD-L1 negative
    Units: month
        arithmetic mean (standard deviation)
    		 5.97 ± 8.57 -
    Time on treatment and PD-L1 positive
    Units: month
        arithmetic mean (standard deviation)
    		 13.18 ± 6.14 -
    Distribution of time on treatment for patients with Integrase Inhibitors
    Units: month
        arithmetic mean (standard deviation)
    		 10.90 ± 13.13 -
    Distribution of time on treatment for patients without Integrase Inhibitors
    Units: month
        arithmetic mean (standard deviation)
    		 3.67 ± 3.99 -

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Durvalumab 1500 mg IV commences on Day 1 following confirmation of eligibility into the study and continues on a Q4W schedule until confirmed PD (unless the investigator considers the subject to continue to receive benefit from treatment), initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or if other reasons to discontinue study treatment occur.

    Primary: Efficacy: Best response during the treatment period

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    End point title
    		 Efficacy: Best response during the treatment period [1]
    End point description
    Durvalumab treatment is confirmed after a long follow-up as a feasible and active treatment in HIV-1-infected cancer patients under cART. HIV-1-infected subjects on suppressive antiretroviral therapy and advanced cancer had clinical benefit in 45% of cases, including patients with long lasting responses.
    End point type
    Primary
    End point timeframe
    From the first dose until end of study.
    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: Kaplan Meier method will be used to estimate the survival function. Secondary measurements will be PFS rate at 6 months and OS rate at 12 months.
    End point values
    		 Experimental
    Number of subjects analysed
    20
    Units: Subject
        Complete Response
    1
        Partial Response
    3
        Stable disease
    5
        Progression Disease
    7
        Not Evaluated
    4
    No statistical analyses for this end point

    Secondary: Duration of response global

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    End point title
    		 Duration of response global
    End point description
    Only patients with best response Stable disease, Partial Response or Complete response during the treatment period are included in the response analysis.
    End point type
    Secondary
    End point timeframe
    Duration of response is the time from response (R) to progression/death (P/D).
    End point values
    		 Experimental
    Number of subjects analysed
    9
    Units: month
    arithmetic mean (standard deviation)
        Anal
    3.78 ± 0
        Melanoma
    7.39 ± 0
        NSCLC
    13.90 ± 16.35
    No statistical analyses for this end point

    Secondary: Duration of response- Dolutegravir/ no Dolutegravir

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    End point title
    		 Duration of response- Dolutegravir/ no Dolutegravir
    End point description
    Only patients with best response Stable disease, Partial Response or Complete response during the treatment period are included in the response analysis.
    End point type
    Secondary
    End point timeframe
    Duration of response is the time from response (R) to progression/death (P/D).
    End point values
    		 Experimental
    Number of subjects analysed
    9
    Units: month
    median (confidence interval 95%)
        Dolutegravir
    27.4 (3.7 to 40)
        No Dolutegravir
    2.8 (1.2 to 3.8)
    No statistical analyses for this end point

    Secondary: Duration of response by treatment with INSTIs or no INSTIs

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    End point title
    		 Duration of response by treatment with INSTIs or no INSTIs
    End point description
    Only patients with best response Stable disease, Partial Response or Complete response during the treatment period are included in the response analysis.
    End point type
    Secondary
    End point timeframe
    Duration of response is the time from response to progression/death.
    End point values
    		 Experimental
    Number of subjects analysed
    9
    Units: month
    median (confidence interval 95%)
        Integrase Inhibitors
    11.32 (3.71 to 27.40)
        No Integrase Inhibitors
    2.10 (1.22 to 3.78)
    No statistical analyses for this end point

    Secondary: OS analysis by PD-L1

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    End point title
    		 OS analysis by PD-L1
    End point description
    Kaplan Meier method will be used to estimate the survival function. OS will be mesure at 12 months.
    End point type
    Secondary
    End point timeframe
    OS is defined as the time from the inclusion date to the death, due to any cause. A patient who does not dies, is censored at the last contact date.
    End point values
    		 Experimental
    Number of subjects analysed
    15
    Units: month
    median (confidence interval 95%)
        PDL-1 negative
    7.4 (1.2 to 16.3)
        PDL-1 positive
    18.9 (17.0 to 25)
    No statistical analyses for this end point

    Secondary: OS analysis by Integrase Inhibitors

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    End point title
    		 OS analysis by Integrase Inhibitors
    End point description
    End point type
    Secondary
    End point timeframe
    OS is defined as the time from the inclusion date to the death, due to any cause. A patient who does not dies, is censored at the last contact date.
    End point values
    		 Experimental
    Number of subjects analysed
    20
    Units: month
    median (confidence interval 95%)
        Integrase Inhibitors
    11.5 (4.8 to 18.8)
        No Integrase Inhibitors
    6.0 (0.4 to 33.3)
    No statistical analyses for this end point

    Secondary: OS analysis by Dolutegravir

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    End point title
    		 OS analysis by Dolutegravir
    End point description
    End point type
    Secondary
    End point timeframe
    OS is defined as the time from the inclusion date to the death, due to any cause. A patient who does not dies, is censored at the last contact date.
    End point values
    		 Experimental
    Number of subjects analysed
    20
    Units: month
    median (confidence interval 95%)
        Dolutegravir
    1.0 (1.0 to 18.8)
        No Dolutegravir
    0.4 (0.4 to 19.1)
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Kaplan Meier method will be used to estimate the survival function. PFS rate will be mesure at 6 months
    End point type
    Secondary
    End point timeframe
    PFS is defined as the time from the inclusion date to the progression or death, due to any cause, date.
    End point values
    		 Experimental
    Number of subjects analysed
    20
    Units: month
        median (confidence interval 95%)
    2.5 (1.4 to 5.9)
    No statistical analyses for this end point

    Secondary: PFS analysis by PD-L1

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    End point title
    		 PFS analysis by PD-L1
    End point description
    End point type
    Secondary
    End point timeframe
    PFS is defined as the time from the inclusion date to the progression or death, due to any cause, date. A patient who does not progresses neither dies, is censored at the last tumor evaluation where no progression is detected.
    End point values
    		 Experimental
    Number of subjects analysed
    15
    Units: month
    median (confidence interval 95%)
        Negative PDL-1
    2.3 (1.2 to 6.2)
        Positivi PDL-1
    5.7 (4.1 to 17.0)
    No statistical analyses for this end point

    Secondary: PFS analysis by Integrase Inhibitors

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    End point title
    		 PFS analysis by Integrase Inhibitors
    End point description
    End point type
    Secondary
    End point timeframe
    PFS is defined as the time from the inclusion date to the progression or death, due to any cause, date.
    End point values
    		 Experimental
    Number of subjects analysed
    20
    Units: month
    median (confidence interval 95%)
        Integrase Inhibitors
    2.5 (1.4 to 9.6)
        No Integrase Inhibitors
    2.5 (0.4 to 6.2)
    No statistical analyses for this end point

    Secondary: PFS analysis by Dolutegravir

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    End point title
    		 PFS analysis by Dolutegravir
    End point description
    End point type
    Secondary
    End point timeframe
    PFS is defined as the time from the inclusion date to the progression or death, due to any cause, date.
    End point values
    		 Experimental
    Number of subjects analysed
    20
    Units: month
    median (confidence interval 95%)
        Dolutegravir
    4.2 (1.0 to 17.0)
        No Dolutegravir
    2.3 (0.4 to 4.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any adverse event or breakdown occurring during the course of the study. The investigator will have to collect all adverse events once they have signed informed consent, during treatment and 90 days after the last administration of Durvalumab.
    Adverse event reporting additional description
    The severity of AE will be determined using CTCAE version 4.0.3
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Subjects per protocol
    Reporting group description
    		 -

    Serious adverse events
    		 Subjects per protocol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 20 (55.00%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    4
    Vascular disorders
    Vascular arterial ischemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death NOS
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    3 / 3
    Pain
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Creatinine increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypercalcemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Oral hemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thromboembolic event
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Gastric hemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory insufficiency
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hemoptysis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic toxicity
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Lung infection
         subjects affected / exposed
    5 / 20 (25.00%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Subjects per protocol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 20 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Thromboembolic event
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Hypertension
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    14 / 20 (70.00%)
         occurrences all number
    14
    Pain
         subjects affected / exposed
    12 / 20 (60.00%)
         occurrences all number
    12
    Fever
         subjects affected / exposed
    6 / 20 (30.00%)
         occurrences all number
    6
    Reproductive system and breast disorders
    Dyspnea
         subjects affected / exposed
    7 / 20 (35.00%)
         occurrences all number
    7
    Prostate syndrom
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 20 (35.00%)
         occurrences all number
    7
    Upper respiratory infection
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Sore throat
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Respiratory insufficiency
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hemoptysis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Confusion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Investigations
    Serum amylase increased
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Creatinine increased
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Percardial effusion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Somnolence
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Neutropenia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    7 / 20 (35.00%)
         occurrences all number
    7
    Vomiting
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Diarrhea
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Dysphagia
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Mucositis oral
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Pancreatitis
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Hepatobiliary disorders
    Hepatic toxicity
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Seborreic dermatitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 20 (50.00%)
         occurrences all number
    10
    Infections and infestations
    Lung infection
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    4
    Non respiratory infection
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    7 / 20 (35.00%)
         occurrences all number
    7
    Hyperkalemia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2017
    Updating information regarding the safety of the investigational product and adverse effects in the protocol and in the patient information sheet and inform consent. Correct and expand the inclusion/exclusion criteria.Update management of toxicities.
    10 May 2018
    Make two changes to the inclusion/exclusion criteria.
    19 Jan 2019
    Change of Sponsor.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32271353
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