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    Clinical Trial Results:
    A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex®-induced Photochemical Internalisation (PCI) of Gemcitabine Followed by Gemcitabine/Cisplatin Chemotherapy in Patients with Advanced Inoperable Cholangiocarcinomas

    Summary
    EudraCT number
    2012-002888-10
    Trial protocol
    GB   DE   FR   LT   NO   AT  
    Global end of trial date
    21 Feb 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    23 May 2021
    First version publication date
    23 May 2021
    Other versions
    Summary report(s)
    PCI-A202-12 CSR synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    PCI A202/12
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01900158
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    PCI Biotech AS
    Sponsor organisation address
    Ullernchausséen 64, Oslo, Norway, N-0379
    Public contact
    Regulatory Affairs, Theradex (Europe) Ltd, +44 01293510319, regulatory@theradex.co.uk
    Scientific contact
    Clinical Trial Disclosure Desk, PCI Biotech AS, +47 67 11 54 00,
    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 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I Dose Escalation • To determine a tolerable dose and safety profile of Amphinex-induced PCI of gemcitabine followed by systemic gemcitabine/cisplatin chemotherapy in patients with advanced inoperable cholangiocarcinoma Extended Part of Phase I • To determine the tolerability and safety profile of a two-administration schedule of Amphinex-induced PCI of gemcitabine followed by systemic gemcitabine/cisplatin chemotherapy in patients with advanced inoperable cholangiocarcinoma Please note, as the Phase II part of the study was not conducted as planned, therefore the main objective for this part have not been included. A separate Protocol for the modified part of the Phase II study has been prepared.
    Protection of trial subjects
    Photosensitivity following PCI treatment. Patients could be sensitive to light for a period after exposure to fimaporfin, and patients are therefor advised to take precautions to prevent skin and eye sensitivity reactions. Patients receive detailed information about possible reactions, how to protect themselves and how they should gradually increase their light exposure and additionally on how and when to test their degree of photosensitivity.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Nov 2012
    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
    Norway: 2
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Germany: 19
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    13
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    First patient enrolled: 16 January 2014 Last patient last visit: 21 February 2019 Patients recruited at eight centres; six centres in Germany, one centre in the UK, and one centre in Norway

    Pre-assignment
    Screening details
    Patients had to be ≥18 years, have an estimated life expectancy ≥12 weeks and had to have histopathologically/cytologically (C5) verified adenocarcinoma consistent with CCA.

    Period 1
    Period 1 title
    Dose escalation phase (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    None

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 1: 0.06 / 15
    Arm description
    Patients were treated with a single PCI treatment (Amphinex 0.06 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 15 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    Not Applicable
    Other name
    Fimaporfin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex solution for injection was administered at a dose of 0.06 mg/kg intravenously on Day 0.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Not Applicable
    Other name
    Not Applicable
    Pharmaceutical forms
    Powder for solution for infusion, Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single gemcitabine infusion was administered at a dose of 1000 mg/m2 intravenously on Day 4.

    Arm title
    Cohort 2: 0.06 / 30
    Arm description
    Patients were treated with a single PCI treatment (Amphinex 0.06 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    Not Applicable
    Other name
    Fimaporfin
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex solution for injection was administered at a dose of 0.06 mg/kg intravenously on Day 0.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Not Applicable
    Other name
    Not Applicable
    Pharmaceutical forms
    Powder for solution for infusion, Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single gemcitabine infusion was administered at a dose of 1000 mg/m2 intravenously on Day 4.

    Arm title
    Cohort 3: 0.12 / 30
    Arm description
    Patients were treated with a single PCI treatment (Amphinex 0.12 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    Not Applicable
    Other name
    Fimaporfin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex solution for injection was administered at a dose of 0.12 mg/kg intravenously on Day 0.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Not Applicable
    Other name
    Not Applicable
    Pharmaceutical forms
    Powder for solution for infusion, Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single gemcitabine infusion was administered at a dose of 1000 mg/m2 intravenously on Day 4.

    Arm title
    Cohort 4: 0.25 / 30
    Arm description
    Patients were treated with a single PCI treatment (Amphinex 0.25 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    Not Applicable
    Other name
    Fimaporfin
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex solution for injection was administered at a dose of 0.25 mg/kg intravenously on Day 0.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Not Applicable
    Other name
    Not Applicable
    Pharmaceutical forms
    Powder for solution for infusion, Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single gemcitabine infusion was administered at a dose of 1000 mg/m2 intravenously on Day 4.

    Arm title
    Cohort 5: 0.25 / 30 (Extended Part)
    Arm description
    Patients were treated with up to two PCI treatments (Amphinex 0.25 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) with recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. If a patient received a second PCI treatment, the intraluminal laser light and single gemcitabine administration was to take place on the planned Day 1 of Cycle 5 treatment (no cisplatin was given, only gemcitabine as part of the PCI treatment). After the intraluminal laser light, patients resumed the 21-day cycle of treatment with combination chemotherapy on Day 8 of Cycle 5 for up to a total of eight cycles. Amphinex and gemcitabine were considered IMPs in this study.
    Arm type
    Experimental

    Investigational medicinal product name
    Amphinex
    Investigational medicinal product code
    Not Applicable
    Other name
    Fimaporfin
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Amphinex solution for injection was administered at a dose of 0.25 mg/kg intravenously on Day 0. Patients could receive a second PCI treatment at the end of Cycle 4 of the combination chemotherapy treatment (gemcitabine/cisplatin). The second PCI treatment included a single intravenous dose of Amphinex on Day 18 of Cycle 4.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Not Applicable
    Other name
    Not Applicable
    Pharmaceutical forms
    Powder for solution for injection/infusion, Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A gemcitabine infusion was administered at a dose of 1000 mg/m2 intravenously on Day 4. If a patient received a second PCI treatment, a second gemcitabine infusion was administered at a dose of 1000 mg/m2 intravenously 4 days after the second Amphinex dose (Day 1 of Cycle 5).

    Number of subjects in period 1 [1]
    Cohort 1: 0.06 / 15 Cohort 2: 0.06 / 30 Cohort 3: 0.12 / 30 Cohort 4: 0.25 / 30 Cohort 5: 0.25 / 30 (Extended Part)
    Started
    3
    3
    4
    6
    7
    Completed
    2
    3
    3
    3
    5
    Not completed
    1
    0
    1
    3
    2
         Progressive disease
    -
    -
    -
    1
    2
         Physician decision
    -
    -
    -
    2
    -
         Consent withdrawn by subject
    1
    -
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 23 patients were enrolled and treated. In addition, one patient (Patient 24) was enrolled but not treated; this patient was enrolled in error due to a screeing failure as inclusion criteria were not met.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: 0.06 / 15
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.06 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 15 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 2: 0.06 / 30
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.06 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 3: 0.12 / 30
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.12 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 4: 0.25 / 30
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.25 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 5: 0.25 / 30 (Extended Part)
    Reporting group description
    Patients were treated with up to two PCI treatments (Amphinex 0.25 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) with recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. If a patient received a second PCI treatment, the intraluminal laser light and single gemcitabine administration was to take place on the planned Day 1 of Cycle 5 treatment (no cisplatin was given, only gemcitabine as part of the PCI treatment). After the intraluminal laser light, patients resumed the 21-day cycle of treatment with combination chemotherapy on Day 8 of Cycle 5 for up to a total of eight cycles. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group values
    Cohort 1: 0.06 / 15 Cohort 2: 0.06 / 30 Cohort 3: 0.12 / 30 Cohort 4: 0.25 / 30 Cohort 5: 0.25 / 30 (Extended Part) Total
    Number of subjects
    3 3 4 6 7 23
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    3 1 1 5 3 13
        Adults (65 years and over)
    0 2 3 1 4 10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    61.7 ± 3.21 66.7 ± 5.69 72.8 ± 7.14 59.0 ± 9.10 68.3 ± 8.13 -
    Gender categorical
    Units: Subjects
        Female
    1 3 3 6 7 20
        Male
    2 0 1 0 0 3
    Race (NIH/OMB)
    Units: Subjects
        White
    3 3 4 6 7 23
    Ethnicity (NIH/OMB)
    Units: Subjects
        Not Hispanic
    3 3 4 6 7 23
    ECOG Performance Status
    Units: Subjects
        equals 0
    3 2 4 4 3 16
        equals 1
    0 1 0 2 4 7
    Total sum of longest diameter of target lesions
    Units: millimeter(s)
        arithmetic mean (standard deviation)
    23.50 ± 12.021 28.00 ± 12.728 41.67 ± 25.968 51.80 ± 24.722 57.70 ± 33.874 -

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: 0.06 / 15
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.06 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 15 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 2: 0.06 / 30
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.06 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 3: 0.12 / 30
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.12 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 4: 0.25 / 30
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.25 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 5: 0.25 / 30 (Extended Part)
    Reporting group description
    Patients were treated with up to two PCI treatments (Amphinex 0.25 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) with recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. If a patient received a second PCI treatment, the intraluminal laser light and single gemcitabine administration was to take place on the planned Day 1 of Cycle 5 treatment (no cisplatin was given, only gemcitabine as part of the PCI treatment). After the intraluminal laser light, patients resumed the 21-day cycle of treatment with combination chemotherapy on Day 8 of Cycle 5 for up to a total of eight cycles. Amphinex and gemcitabine were considered IMPs in this study.

    Primary: Number of subjects with dose-limiting toxicities (DLTs; Cohorts 1, 2, 3 and 4) or schedule limiting toxicities (SLTs; Cohort 5), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and discontinuations due to TEAEs

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    End point title
    Number of subjects with dose-limiting toxicities (DLTs; Cohorts 1, 2, 3 and 4) or schedule limiting toxicities (SLTs; Cohort 5), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and discontinuations due to TEAEs [1]
    End point description
    DLTs were defined as a clinically significant toxicity or abnormal laboratory value assessed as unrelated to the underlying disease, or concomitant medications, related to either PCI treatment or to the combination of PCI treatment with cisplatin/gemcitabine systemic chemotherapy and met criteria based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02. An SLT was defined as a clinically significant toxicity or abnormal laboratory value assessed as unrelated to the underlying disease or concomitant medications and met criteria based on the NCI CTCAE Version 4.02. A TEAE was defined as an AE that started on or after the start day of study treatment until up to 30 days after the last study treatment. An SAE was any unfavourable medical occurrence that at any dose resulted in any medically important condition considered by the Investigator.
    End point type
    Primary
    End point timeframe
    DLTs - start of the first PCI treatment up to the end of the first chemotherapy cycle. SLTs - start of the second PCI treatment up to the end of the 21-day cycle of treatment with systemic cisplatin and gemcitabine
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study was not formally statistically powered and no statistical hypotheses were tested. Data were summarised descriptively.
    End point values
    Cohort 1: 0.06 / 15 Cohort 2: 0.06 / 30 Cohort 3: 0.12 / 30 Cohort 4: 0.25 / 30 Cohort 5: 0.25 / 30 (Extended Part)
    Number of subjects analysed
    3
    3
    4
    6
    7
    Units: Subjects
        DLTs/SLTs
    0
    0
    0
    0
    0
        TEAEs
    3
    3
    4
    6
    7
        SAEs
    2
    2
    4
    4
    6
        Discontinuations due to TEAEs
    0
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Pharmacokinetic profile of Amphinex (fimaporfin) and gemcitabine in plasma

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    End point title
    Pharmacokinetic profile of Amphinex (fimaporfin) and gemcitabine in plasma
    End point description
    The following pharmacokinetic parameters were used to determine the PK profile of fimaporfin and gemcitabine: elimination half life, total clearance, volume of distribution, maximum plasma concentration, area under the plasma concentration versus time curve.
    End point type
    Secondary
    End point timeframe
    Amphinex PK samples were collected ≤24hrs pre Amphinex administration and at various times after Amphinex administration. Gemcitabine PK samples were collected ≤24hrs pre Gemcitabine administration and at various times after administration.
    End point values
    Cohort 1: 0.06 / 15 Cohort 2: 0.06 / 30 Cohort 3: 0.12 / 30 Cohort 4: 0.25 / 30 Cohort 5: 0.25 / 30 (Extended Part)
    Number of subjects analysed
    3
    3
    4
    6
    7
    Units: Total
        number (not applicable)
    3
    3
    4
    6
    7
    Attachments
    Untitled (Filename: Secondary endpoint_Pharmacokinetic Profile.pdf)
    No statistical analyses for this end point

    Secondary: Progression-Free Survival

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    End point title
    Progression-Free Survival
    End point description
    Progression-free survival was defined as the time from registration to documented disease progression (according to RECIST 1.1 criteria) or death from any cause.
    End point type
    Secondary
    End point timeframe
    Progression free survival was assessed using 6-month scan data. Sufficient data were not available to perform this analysis based on time to progression or death (per protocol) as only survival data were collected during the follow-up period.
    End point values
    Cohort 1: 0.06 / 15 Cohort 2: 0.06 / 30 Cohort 3: 0.12 / 30 Cohort 4: 0.25 / 30 Cohort 5: 0.25 / 30 (Extended Part)
    Number of subjects analysed
    3
    3
    4
    6
    6
    Units: Subjects
        Subjects evaluable for PFS
    3
    3
    4
    6
    6
        PFS at 6-month scan
    2
    3
    3
    4
    3
    No statistical analyses for this end point

    Secondary: Best Overall Response (BOR)

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    End point title
    Best Overall Response (BOR)
    End point description
    The BOR was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease the smallest measurements recorded since the treatment started). The patient’s BOR assignment was dependant on findings of both target and non-target disease and also took into consideration the appearance of new lesions. Overall response categories were Complete Response (CR), Partial Response (PR), Stable Disease (SD), Not Evaluable (NE) and Progressive Disease (PD).
    End point type
    Secondary
    End point timeframe
    Due to limited data available at 24 weeks, this analysis would not be meaningful. A summary of BOR regardless of timepoint was analysed.
    End point values
    Cohort 1: 0.06 / 15 Cohort 2: 0.06 / 30 Cohort 3: 0.12 / 30 Cohort 4: 0.25 / 30 Cohort 5: 0.25 / 30 (Extended Part)
    Number of subjects analysed
    2
    3
    3
    6
    5
    Units: Subjects
        Subjects evaluable for BOR
    2
    3
    3
    6
    5
        Complete Response
    0
    0
    1
    0
    0
        Partial Response
    0
    0
    1
    3
    1
        Stable Disease
    2
    3
    1
    1
    1
        Progressive Disease
    0
    0
    0
    1
    3
        Not Evaluable
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs/SAEs were recorded from time of informed consent until up to 30 days after the study treatment. After 30 days, only AEs/SAEs considered related to the study treatment or significant were reported.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1+20.1
    Reporting groups
    Reporting group title
    Cohort 1: 0.06 / 15
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.06 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 15 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 2: 0.06 / 30
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.06 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 3: 0.12 / 30
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.12 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 4: 0.25 / 30
    Reporting group description
    Patients were treated with a single PCI treatment (Amphinex 0.25 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) followed by recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. Amphinex and gemcitabine were considered IMPs in this study.

    Reporting group title
    Cohort 5: 0.25 / 30 (Extended Part)
    Reporting group description
    Patients were treated with up to two PCI treatments (Amphinex 0.25 mg/kg + gemcitabine 1000 mg/m2 and intraluminal laser light 30 J/cm) with recognised standard of care treatment for this indication: systemic chemotherapy consisting of up to eight cycles of cisplatin 25 mg/m2 plus gemcitabine 1000 mg/m2. If a patient received a second PCI treatment, the intraluminal laser light and single gemcitabine administration was to take place on the planned Day 1 of Cycle 5 treatment (no cisplatin was given, only gemcitabine as part of the PCI treatment). After the intraluminal laser light, patients resumed the 21-day cycle of treatment with combination chemotherapy on Day 8 of Cycle 5 for up to a total of eight cycles. Amphinex and gemcitabine were considered IMPs in this study.

    Serious adverse events
    Cohort 1: 0.06 / 15 Cohort 2: 0.06 / 30 Cohort 3: 0.12 / 30 Cohort 4: 0.25 / 30 Cohort 5: 0.25 / 30 (Extended Part)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    4 / 4 (100.00%)
    4 / 6 (66.67%)
    6 / 7 (85.71%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    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
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    3 / 4 (75.00%)
    2 / 6 (33.33%)
    6 / 7 (85.71%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
    0 / 10
    0 / 2
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disease
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    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
    Cholangitis infective
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridial infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    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
    Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    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
    Sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Cohort 1: 0.06 / 15 Cohort 2: 0.06 / 30 Cohort 3: 0.12 / 30 Cohort 4: 0.25 / 30 Cohort 5: 0.25 / 30 (Extended Part)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    6 / 6 (100.00%)
    7 / 7 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
    3 / 7 (42.86%)
         occurrences all number
    0
    1
    0
    2
    3
    Hypotension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Surgical and medical procedures
    Cholangiostomy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    2 / 4 (50.00%)
    4 / 6 (66.67%)
    4 / 7 (57.14%)
         occurrences all number
    3
    4
    2
    5
    8
    Fatigue
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    4
    1
    0
    1
    2
    Swelling
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    2
    1
    Chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
         occurrences all number
    0
    0
    0
    1
    2
    Chills
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    2
    0
    0
    3
    Mucosal inflammation
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    3
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    1
    Chest discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Disease progression
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Mental disorder
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Vascular access complication
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Burns second degree
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tooth fracture
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    3 / 7 (42.86%)
         occurrences all number
    1
    0
    1
    0
    6
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    2
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Platelet count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Body temperature
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Haematocrit decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood magnesium decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Monocyte count increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Troponin T increased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    0
    0
    1
    Atrial flutter
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    3 / 4 (75.00%)
    4 / 6 (66.67%)
    3 / 7 (42.86%)
         occurrences all number
    6
    3
    6
    11
    6
    Leukopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 4 (50.00%)
    4 / 6 (66.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    3
    2
    11
    5
    Thrombocytopenia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    3 / 6 (50.00%)
    3 / 7 (42.86%)
         occurrences all number
    2
    0
    0
    6
    10
    Anaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    4 / 7 (57.14%)
         occurrences all number
    0
    0
    1
    0
    6
    Lymphopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    2
    3
    Pancytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    1
    0
    0
    0
    2
    Dyspnoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    0
    1
    1
    Polyneuropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    1
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hypertonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 3 (100.00%)
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    2 / 6 (33.33%)
    6 / 7 (85.71%)
         occurrences all number
    4
    1
    1
    2
    9
    Abdominal pain
         subjects affected / exposed
    3 / 3 (100.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    3 / 6 (50.00%)
    4 / 7 (57.14%)
         occurrences all number
    6
    1
    0
    4
    8
    Vomiting
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    3 / 7 (42.86%)
         occurrences all number
    1
    2
    1
    1
    3
    Constipation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    1
    0
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    2
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Ascites
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Abdominal distension
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Nephropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Renal failure acute
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    3 / 4 (75.00%)
    3 / 6 (50.00%)
    6 / 7 (85.71%)
         occurrences all number
    4
    2
    10
    4
    23
    Hepatobiliary disease
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Jaundice
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cholestasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Haemobilia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Hepatic pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
         subjects affected / exposed
    3 / 3 (100.00%)
    2 / 3 (66.67%)
    3 / 4 (75.00%)
    4 / 6 (66.67%)
    6 / 7 (85.71%)
         occurrences all number
    6
    7
    18
    7
    34
    Night sweats
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    1
    Urticaria
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    Hyperkeratosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nail discolouration
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nail dystrophy
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Alopecia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    0
    0
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
         occurrences all number
    0
    0
    0
    0
    2
    Pain in extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    1
    0
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Gout
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    1
    0
    0
    0
    1
    Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    3
    Cholangitis infective
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    2
    Abscess
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Biliary sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Catheter site infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Clostridial infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ear infection
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal fungal infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Peritonitis bacterial
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Septic shock
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    1
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2012
    Exclusion criteria updated.
    21 Feb 2013
    Inclusion criteria revised. Additional cohorts added to the Dose Escalation Part of the study to explore different intraluminal laser light settings.
    19 Mar 2014
    Additional exclusion criteria added: Patients defined as vulnerable according to French law. Addition of definition of vulnerable according to French law added to Section 5.4 of the protocol.
    02 May 2014
    Additional details added to describe the composition, role, and ways of functioning of the CRC. Updated for Phase II part of the study (not applicable from this CSR): Details of Independent Data Monitoring Board added.
    19 Dec 2014
    Updated per Amendments 3 and 4 with the exception of details of Independent Data Monitoring Board. Population changed from patients with ‘locally advanced inoperable cholangiocarcinomas’ to those with ‘advanced inoperable cholangiocarcinomas’: Patients with metastatic disease were also allowed to enter the study. Addition of exploratory endpoints to evaluate immune-modulating effects of the PCI procedure and presence of Amphinex in faecal samples.
    08 Jun 2016
    Allowed metastatic disease to be confined to the liver only. Primary lesion to be in the perihilar duct region. Serum (total) bilirubin >2.5 x the Upper Limit of Normal (ULN) for the institution, instead of >1.5 x ULN. ECOG was restricted to 0 to 1 (previously 0 to 2). Updated for Phase II part of the study (not applicable to this CSR): Addition of two exploratory endpoints, independent central review of CT scans, and a Steering Committee.
    24 Mar 2017
    Addition of Extended Part of Phase I. Clarification that gemcitabine/cisplatin given as systemic chemotherapy are not considered IMPs.
    12 Sep 2017
    Clarification that patients in the Extended Part of Phase I with progressive disease could receive a second PCI treatment if, in the opinion of the Investigator, the patient would benefit from this treatment. Addition of radiological evaluation of tumour prior to second PCI treatment in Extended Part of Phase I.
    10 Nov 2017
    Addition of two exclusion criteria regarding use of photosensitising drugs and amiodarone. Additional detail provided regarding management of potential photosensitivity reactions. Clarification that all patients were to be stented.
    22 Mar 2018
    Additional detail added regarding choice of light dose and rationale for Extended Part of Phase I. Clarification that patients in the Extended Part of Phase I with progressive disease could receive a second PCI treatment if, in the opinion of the Investigator, the patient would benefit from this treatment. Addition of radiological evaluation of tumour prior to second PCI treatment in Extended Part of Phase I.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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