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    Clinical Trial Results:
    A MULTICENTER, PHASE I/II STUDY OF SEQUENTIAL EPIGENETIC AND IMMUNE TARGETING IN COMBINATION WITH NAB-PACLITAXEL/GEMCITABINE IN PATIENTS WITH ADVANCED PANCREATIC DUCTAL ADENOCARCINOMA

    Summary
    EudraCT number
    		 2017-001625-40
    Trial protocol
    		 DE  
    Global end of trial date
    02 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Feb 2026
    First version publication date
    28 Feb 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AX-CL-PANC-PI-008619
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04257448
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GWT-TUD GmbH
    Sponsor organisation address
    Freiberger Str. 33, Dresden, Germany, 01067
    Public contact
    FB MEDIZIN, GWT-TUD GmbH, +49 35125933100, medical.consulting@g-wt.de
    Scientific contact
    FB MEDIZIN, GWT-TUD GmbH, +49 35125933100, medical.consulting@g-wt.de
    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
    17 Jul 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study, including the dose escalating part (Part 1a), the dose expansion part (Part 1b) as well as the consolidation part (Part 2), is to determine the safety and tolerability of Azacitidine and/or Romidepsin in combination with nab-Paclitaxel/Gemcitabine, followed by sequential immune targeting with PD-L1 blockade in combination with low-dose Lenalidomide in patients with advanced PDAC (Part 1 and 2). Moreover, in the dose escalating part of the study (Part 1a), the recommended dose for expansion and dose-limiting toxicity of Azacitidine and/or Romidepsin in combination with nab-Paclitaxel/Gemcitabine will be identified.
    Protection of trial subjects
    An independent data safety monitoring board was established to supervise the conduct of this trial. The DMC issued recommendations for early termination, modifications or continuation of the trial according to the DMC Operating Procedure. Based on the novel combination regimen applied in this study, the DMC monitored safety and efficacy data every 3 to 6 months (at least twice a year) throughout the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 73
    Worldwide total number of subjects
    73
    EEA total number of subjects
    73
    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
    33
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Clinical conduct of the study was between 25 May 2020 (date of first informed consent) and 02 Jul 2024 (LPLV). Overall, 85 patients were screened at 9 participating sites across Germany.

    Pre-assignment
    Screening details
    		 75 out of 85 patients were assigned to treatment: 19 patients in Part 1a of the study, with 6 continuing to Part 1b, additional 33 patients in Part 1b and 23 patients were assigned to the standard arm. In total, 39 patients were treated with RDE (Recommended Dose for Expansion).

    Period 1
    Period 1 title
    Part 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Arm A (dose escalation)
    Arm description
    		 Part 1a employed a standard 3 + 3 design to test safety and tolerability. Study treatment was given until intolerable toxicity. Treatment was escalated until the recommended dose was identified.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Romidepsin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Romidepsin (dose range: 2 - 7 mg/m²) was administered on Day 1, Day 8 and Day 15 (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    nab-Paclitaxel was given on Day 1, Day 8 and Day 15 at a dose of 125 mg/m² (every 28 days) of each treatment cycle. nab-Paclitaxel was administered sequentially with Gemcitabine. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was given on Day 1, Day 8 and Day 15 at a dose of 1000 mg/m² (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Arm title
    		 Arm B (dose escalation)
    Arm description
    		 Part 1a employed a standard 3 + 3 design to test safety and tolerability. Study treatment was given until intolerable toxicity. Treatment was escalated until the recommended dose was identified.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Vidaza®
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Azacitidine(dose range: 20- 40 mg/m²) was administered on Day -7 to Day -3 (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    nab-Paclitaxel was given on Day 1, Day 8 and Day 15 at a dose of 125 mg/m² (every 28 days) of each treatment cycle. nab-Paclitaxel was administered sequentially with Gemcitabine. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was given on Day 1, Day 8 and Day 15 at a dose of 1000 mg/m² (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Arm title
    		 Arm C (dose escalation)
    Arm description
    		 Part 1a employed a standard 3 + 3 design to test safety and tolerability. Study treatment was given until intolerable toxicity. Treatment was escalated until the recommended dose was identified.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Romidepsin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Romidepsin was given on Day 1, Day 8 and Day 15 at a dose of 2 mg/m² (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Vidaza®
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Azacitidine was given on Day -7 to Day -3 at a dose of 30 mg/m² (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    nab-Paclitaxel was given on Day 1, Day 8 and Day 15 at a dose of 125 mg/m² (every 28 days) of each treatment cycle. nab-Paclitaxel was administered sequentially with Gemcitabine. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was given on Day 1, Day 8 and Day 15 at a dose of 1000 mg/m² (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Arm title
    		 Standard arm
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    nab-Paclitaxel was given on Day 1, Day 8 and Day 15 at a dose of 125 mg/m² (every 28 days) of each treatment cycle. nab-Paclitaxel was administered sequentially with Gemcitabine. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was given on Day 1, Day 8 and Day 15 at a dose of 1000 mg/m² (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Arm title
    		 Arm B (dose expansion)
    Arm description
    		 One of the treatment arms (Arm C over Arm B over Arm A) was planned to be continued and additional patients were recruited. Selection of the expansion arm was as follows in case of successful determination of the RDE: Arm C preferred over Arm B over Arm A. For Part 1b the treatment regimen of Arm B dose level L1 (30 mg/m² azacitidine sc on day -7 to day -3) in combination with nab-paclitaxel/gemcitabine (day 1, day 8 and day 15 at a dose of 125 mg/m² iv and 1000 mg/m², respectively) was selected.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Vidaza®
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Azacitidine was given on Day -7 to Day -3 at a dose of 30 mg/m² (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    nab-Paclitaxel was given on Day 1, Day 8 and Day 15 at a dose of 125 mg/m² (every 28 days) of each treatment cycle. nab-Paclitaxel was administered sequentially with Gemcitabine. Study treatment was given for a maximum of 3 cycles.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine was given on Day 1, Day 8 and Day 15 at a dose of 1000 mg/m² (every 28 days) of each treatment cycle. Study treatment was given for a maximum of 3 cycles.

    Number of subjects in period 1
    		Arm A (dose escalation) Arm B (dose escalation) Arm C (dose escalation) Standard arm Arm B (dose expansion)
    Started
    6
    10
    3
    23
    39
    Completed
    6
    10
    3
    15
    27
    Not completed
    0
    0
    0
    8
    12
         Consent withdrawn by subject
    -
    -
    -
    2
    -
         Physician decision
    -
    -
    -
    1
    -
         Adverse event, non-fatal
    -
    -
    -
    1
    1
         Lost to follow-up
    -
    -
    -
    -
    1
         Reason missing
    -
    -
    -
    1
    1
         Lack of efficacy
    -
    -
    -
    3
    8
         Protocol deviation
    -
    -
    -
    -
    1
    Period 2
    Period 2 title
    Part 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Consolidation therapy
    Arm description
    		 All patients from Part 1 (dose escalation and expansion cohorts from experimental arms and standard arm) who did not progress after three cycles of gemcitabine/nab-paclitaxel/ (GnP) with or without additional epigenetic treatment received sequential immune targeting with PD-L1 blockade (standard fixed dose of durvalumab 1500 mg/kg q4w iv) in combination with low-dose lenalidomide (10 mg d1-21 q4w po) until documented disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Imfinzi®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Standard fixed dose of durvalumab 1500 mg/kg q4w iv in combination with low-dose lenalidomide until documented disease progression

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Revlimid®
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg d1-21 q4w po until documented disease progression

    Number of subjects in period 2
    		Consolidation therapy
    Started
    46
    Completed
    12
    Not completed
    34
         Consent withdrawn by subject
    1
         Lack of efficacy
    33

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1
    Reporting group description
    		 -

    Reporting group values
    		 Part 1 Total
    Number of subjects
    		 73 73
    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
        log mean (standard deviation)
    		 62.6 ( 9.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 35 35
        Male
    		 38 38

    End points

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    End points reporting groups
    Reporting group title
    Arm A (dose escalation)
    Reporting group description
    		 Part 1a employed a standard 3 + 3 design to test safety and tolerability. Study treatment was given until intolerable toxicity. Treatment was escalated until the recommended dose was identified.

    Reporting group title
    Arm B (dose escalation)
    Reporting group description
    		 Part 1a employed a standard 3 + 3 design to test safety and tolerability. Study treatment was given until intolerable toxicity. Treatment was escalated until the recommended dose was identified.

    Reporting group title
    Arm C (dose escalation)
    Reporting group description
    		 Part 1a employed a standard 3 + 3 design to test safety and tolerability. Study treatment was given until intolerable toxicity. Treatment was escalated until the recommended dose was identified.

    Reporting group title
    Standard arm
    Reporting group description
    		 -

    Reporting group title
    Arm B (dose expansion)
    Reporting group description
    		 One of the treatment arms (Arm C over Arm B over Arm A) was planned to be continued and additional patients were recruited. Selection of the expansion arm was as follows in case of successful determination of the RDE: Arm C preferred over Arm B over Arm A. For Part 1b the treatment regimen of Arm B dose level L1 (30 mg/m² azacitidine sc on day -7 to day -3) in combination with nab-paclitaxel/gemcitabine (day 1, day 8 and day 15 at a dose of 125 mg/m² iv and 1000 mg/m², respectively) was selected.
    Reporting group title
    Consolidation therapy
    Reporting group description
    		 All patients from Part 1 (dose escalation and expansion cohorts from experimental arms and standard arm) who did not progress after three cycles of gemcitabine/nab-paclitaxel/ (GnP) with or without additional epigenetic treatment received sequential immune targeting with PD-L1 blockade (standard fixed dose of durvalumab 1500 mg/kg q4w iv) in combination with low-dose lenalidomide (10 mg d1-21 q4w po) until documented disease progression.

    Primary: Adverse Events

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    End point title
    		 Adverse Events [1]
    End point description
    End point type
    Primary
    End point timeframe
    3 cycles
    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: There were no statistical hypotheses. The emphasis of the analyses was on estimation of key summary statistics.
    End point values
    		 Arm A (dose escalation) Arm B (dose escalation) Arm C (dose escalation) Standard arm Arm B (dose expansion)
    Number of subjects analysed
    6
    10
    3
    23
    37
    Units: subjects with at least one event
    number (not applicable)
        AE unrelated
    6
    10
    3
    22
    33
        AE related to Azacitidine
    0
    4
    3
    0
    28
        AE related to Romidepsin
    5
    0
    3
    0
    5
        AE related to nab-Paclitaxel
    5
    4
    3
    22
    33
        AE related to Gemcitabine
    5
    4
    3
    21
    33
        AE related, but relation unknown
    1
    0
    0
    0
    0
        SAE unrelated
    3
    1
    1
    7
    13
        SAE related to Azacitidine
    0
    0
    0
    0
    5
        SAE related to Romidepsin
    2
    0
    1
    0
    0
        SAE related to nab-Paclitaxel
    1
    0
    2
    5
    7
        SAE related to Gemcitabine
    1
    0
    2
    5
    7
        Fatal event
    1
    1
    0
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    18 month
    Adverse event reporting additional description
    AE and SAE collection and reporting continued for further 90 days after a patient’s last use of IMP within the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Safety Analysis Set
    Reporting group description
    		 In Part 1 of the study, 73 patients received treatment with study medication and were included in the FAS which corresponds to the safety analysis set (SAF).

    Serious adverse events
    		 Safety Analysis Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 73 (34.25%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tumour associated fever
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Duodenal stenosis
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastric disorder
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea/Vomiting
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    3 / 73 (4.11%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cholangitis
         subjects affected / exposed
    3 / 73 (4.11%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Acute hepatic failure
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Urinary tract infection
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Dehydration
         subjects affected / exposed
    1 / 73 (1.37%)
         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
    		 Safety Analysis Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    68 / 73 (93.15%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    8 / 73 (10.96%)
         occurrences all number
    15
    Cancer fatigue
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Breast cancer
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Tumour associated fever
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    7
    Thrombosis
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5
    Hypotension
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Thrombophlebitis
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Venous thrombosis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Embolism
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Venous thrombosis limb
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Embolism arterial
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 73 (10.96%)
         occurrences all number
    15
    Pyrexia
         subjects affected / exposed
    7 / 73 (9.59%)
         occurrences all number
    11
    Oedema peripheral
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    10
    General physical health deterioration
         subjects affected / exposed
    3 / 73 (4.11%)
         occurrences all number
    3
    Chills
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Oedema
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Pain
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    4
    Injection site reaction
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Adverse drug reaction
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Catheter site thrombosis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Extravasation
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Inflammation
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Amenorrhoea
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Pulmonary embolism
         subjects affected / exposed
    3 / 73 (4.11%)
         occurrences all number
    4
    Dyspnoea exertional
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Dyspnoea
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Epistaxis
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    3
    Pleural effusion
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    3
    Sleep disorder
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Depression
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Agitation
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    2
    Adjustment disorder
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Mental disorder
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    2
    Product issues
    Stent malfunction
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Device malfunction
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    22 / 73 (30.14%)
         occurrences all number
    40
    Aspartate aminotransferase increased
         subjects affected / exposed
    20 / 73 (27.40%)
         occurrences all number
    34
    C-reactive protein increased
         subjects affected / exposed
    10 / 73 (13.70%)
         occurrences all number
    18
    Blood alkaline phosphatase increased
         subjects affected / exposed
    8 / 73 (10.96%)
         occurrences all number
    11
    Blood bilirubin increased
         subjects affected / exposed
    8 / 73 (10.96%)
         occurrences all number
    13
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    5
    Weight decreased
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Lipase increased
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    6
    Haemoglobin increased
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    4
    White blood cell count decreased
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    2
    Platelet count increased
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Blood calcium decreased
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Blood sodium increased
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Blood alkaline phosphatase
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Mycobacterium tuberculosis complex test
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Amylase increased
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Nutritional condition abnormal
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Upper limb fracture
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Diastolic dysfunction
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Nervous system disorders
    Taste disorder
         subjects affected / exposed
    3 / 73 (4.11%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Cerebral ischaemia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Hypotonia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Dysaesthesia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    2
    Orthostatic intolerance
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Polyneuropathy
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 73 (9.59%)
         occurrences all number
    9
    Thrombocytopenia
         subjects affected / exposed
    3 / 73 (4.11%)
         occurrences all number
    3
    Leukocytosis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    24 / 73 (32.88%)
         occurrences all number
    29
    Abdominal pain
         subjects affected / exposed
    15 / 73 (20.55%)
         occurrences all number
    26
    Nausea/Vomiting
         subjects affected / exposed
    11 / 73 (15.07%)
         occurrences all number
    15
    Diarrhoea
         subjects affected / exposed
    11 / 73 (15.07%)
         occurrences all number
    13
    Abdominal pain upper
         subjects affected / exposed
    6 / 73 (8.22%)
         occurrences all number
    6
    Flatulence
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Ascites
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Duodenal stenosis
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Haemorrhoids thrombosed
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    3
    Colitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Abdominal distension
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    2
    Ileus paralytic
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Impaired gastric emptying
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Enteritis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Gastric disorder
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    3
    Stomatitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Ileus
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Abdominal discomfort
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Hiatus hernia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    13
    Cholestasis
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5
    Acute hepatic failure
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Bile duct stenosis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    2
    Hepatic function abnormal
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Dry skin
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    11
    Night sweats
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Dysuria
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Urinary retention
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    4
    Hyperthyroidism
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Thyroid mass
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    8
    Muscle spasms
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Bone pain
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Muscular weakness
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Arthritis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    5 / 73 (6.85%)
         occurrences all number
    5
    Pneumonia
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    3
    Infection
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Biliary sepsis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Anal abscess
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Catheter site infection
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    2
    Cystitis
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Urogenital infection fungal
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    4 / 73 (5.48%)
         occurrences all number
    5
    Decreased appetite
         subjects affected / exposed
    3 / 73 (4.11%)
         occurrences all number
    3
    Hyperuricaemia
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 73 (2.74%)
         occurrences all number
    2
    Vitamin D deficiency
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Hyperphosphataemia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Cachexia
         subjects affected / exposed
    1 / 73 (1.37%)
         occurrences all number
    1
    Dehydration
         subjects affected / exposed
    1 / 73 (1.37%)
         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
    18 Mar 2020
    Protocol V4.0
    06 May 2021
    Protocol V5.0
    28 Jun 2022
    Protocol V6.0

    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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