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    Clinical Trial Results:
    INTRAPERITONEAL AEROSOLISATION OF ALBUMIN-STABILIZED PACLITAXEL NANOPARTICLES FOR PERITONEAL CARCINOMATOSIS – PHASE I/II STUDY PROTOCOL

    Summary
    EudraCT number
    		 2017-001688-20
    Trial protocol
    		 BE   DK  
    Global end of trial date
    29 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Mar 2022
    First version publication date
    11 Mar 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AGO/2017/003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03304210
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Ghent
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    HIRUZ, Ghent University Hospital, +32 93320500, karen.demeuleneir@uzgent.be
    Scientific contact
    HIRUZ, Ghent University Hospital, 093325524 93320500, karen.demeuleneir@uzgent.be
    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
    06 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the safety and efficacy of IV Taxol combined with repeated pressurized intraperitoneal aerosol therapy (PIPAC) using albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) in a multicentre, multinational phase I/II trial.
    Protection of trial subjects
    Ethics review and approval, informed consent. The study followed a time-to-event continual reassessment model (TITE-CRM) The DMC (Data Safety Monitoring Committee) will, based on independent assessment of trial data as they become available, safeguard patient safety and trial integrity. The DMC will take decisions on trial continuation, protocol adaptation, or discontinuation based on efficacy or futility. Adverse events will be reported between the first PIPAC and 30 after the last PIPAC procedure. All AEs and SAE’s will be recorded in the patient’s file and in the CRF. All SAE’s will be reported as described below. Medical events that occur between signing of the Informed Consent and the first intake of trial medication will be documented on the medical and surgical history section and concomitant diseases page of the CRF. SAE’s occurring within a period of 30 days following the last intake of trial medication will also be handled as such if spontaneously reported to the investigator. All serious adverse events (SAE) and pregnancies occurring during clinical trials must be reported by the local Principal Investigator and local Ethical Committee within 2 working days after becoming aware of the SAE. This reporting is done by using the appropriate SAE form. It is the responsibility of the local Principal Investigator to report the local SAE’s to the local EC. In case the investigator decides the SAE is a SUSAR (Suspected Unexpected Serious Adverse Reaction), Bimetra Clinics will report the SUSAR to the Central EC and the CA within the timelines as defined in national legislation. The National Coordinating Investigator reports the SUSAR to all National Coordinating Investigators. In case of a life-threatening SUSAR the entire reporting process must be completed within 7 calendar days. In case of a non-life-threatening SUSAR the reporting process must completed within 15 calendar days.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Sep 2017
    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
    Denmark: 1
    Country: Number of subjects enrolled
    Belgium: 19
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    15
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Thirty-one patients were assessed for eligibility and signed the informed consent form. Between September 2017 and March 2020, treatment was initiated in 23 eligible patients at Ghent University Hospital (n=22) and at Odense University Hospital (n=1). Twenty of them underwent at least two consecutive PIPAC treatments

    Pre-assignment
    Screening details
    		 Inclusion criteria and exclusion criteria

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Abraxane 35 mg/m²
    Arm description
    		 PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    abraxane
    Investigational medicinal product code
    PR1
    Other name
    Albumin bound nanoparticle paclitaxel
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    Abraxane 35 mg/m² Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique.

    Arm title
    		 Abraxane 70 mg/m²
    Arm description
    		 PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    abraxane
    Investigational medicinal product code
    PR1
    Other name
    Albumin bound nanoparticle paclitaxel
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    Abraxane 70 mg/m² Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique.

    Arm title
    		 Abraxane 90 mg/m²
    Arm description
    		 PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    abraxane
    Investigational medicinal product code
    PR1
    Other name
    Albumin bound nanoparticle paclitaxel
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    Abraxane 90 mg/m² Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique.

    Arm title
    		 Abraxane 112.5 mg/m²
    Arm description
    		 PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    abraxane
    Investigational medicinal product code
    PR1
    Other name
    Albumin bound nanoparticle paclitaxel
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    Abraxane 112.5 mg/m² Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique.

    Arm title
    		 Abraxane 140 mg/m²
    Arm description
    		 PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    abraxane
    Investigational medicinal product code
    PR1
    Other name
    Albumin bound nanoparticle paclitaxel
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    Abraxane 140 mg/m² Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique.

    Number of subjects in period 1
    		Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Started
    2
    2
    3
    3
    10
    Completed
    2
    2
    3
    3
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Abraxane 35 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Reporting group title
    Abraxane 70 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Reporting group title
    Abraxane 90 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Reporting group title
    Abraxane 112.5 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Reporting group title
    Abraxane 140 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Reporting group values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m² Total
    Number of subjects
    		 2 2 3 3 10 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 1 0 3 2 9 15
        From 65-84 years
    		 1 2 0 1 1 5
        85 years and over
    		 0 0 0 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 64 (62 to 65) 68 (67 to 68) 52 (49 to 58) 59 (47 to 70) 51 (28 to 66) -
    Gender categorical
    Units: Subjects
        Female
    		 1 2 0 2 7 12
        Male
    		 1 0 3 1 3 8

    End points

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    End points reporting groups
    Reporting group title
    Abraxane 35 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Reporting group title
    Abraxane 70 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Reporting group title
    Abraxane 90 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Reporting group title
    Abraxane 112.5 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Reporting group title
    Abraxane 140 mg/m²
    Reporting group description
    		 PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

    Primary: Maximally Tolerated Dose (MTD) of Abraxane

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    End point title
    		 Maximally Tolerated Dose (MTD) of Abraxane [1]
    End point description
    Dose limiting toxicities will be monitored.
    End point type
    Primary
    End point timeframe
    Within 14 weeks of the start of the treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: NA
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: toxicities
        Abraxane 35 mg/m²
    2
    0
    0
    0
    0
        Abraxane 70 mg/m²
    0
    2
    0
    0
    0
        Abraxane 90 mg/m²
    0
    0
    3
    0
    0
        Abraxane 112.5 mg/m²
    0
    0
    0
    3
    0
        Abraxane 140 mg/m²
    0
    0
    0
    0
    10
    No statistical analyses for this end point

    Secondary: Surgical Morbidity Will be Measured

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    End point title
    		 Surgical Morbidity Will be Measured
    End point description
    This will be estimated with the Dindo-Clavien classification
    End point type
    Secondary
    End point timeframe
    6 months after third PIPAC
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: morbidity
    2
    2
    3
    3
    10
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration of Abraxane

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    End point title
    		 Maximum Plasma Concentration of Abraxane
    End point description
    Abraxane will be measured in plasma, using UPLC-MS/MS.
    End point type
    Secondary
    End point timeframe
    T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hours
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: ng/mL*h
        median (standard deviation)
    58 ( 15 )
    138 ( 42 )
    101 ( 13 )
    157 ( 49 )
    184 ( 68 )
    No statistical analyses for this end point

    Secondary: Area Under The Curve (AUC) of Abraxane

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    End point title
    		 Area Under The Curve (AUC) of Abraxane
    End point description
    Abraxane will be measured in plasma, using LC-MS/MS.
    End point type
    Secondary
    End point timeframe
    T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hours
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: ng/mL*h
        median (standard deviation)
    585 ( 93 )
    962 ( 237 )
    813 ( 99 )
    1658 ( 465 )
    2002 ( 569 )
    No statistical analyses for this end point

    Secondary: Pharmacodynamics (PD) of Abraxane Will be Analysed Using Biomarkers

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    End point title
    		 Pharmacodynamics (PD) of Abraxane Will be Analysed Using Biomarkers
    End point description
    Tumour markers will be analysed - CA15.3 in case of breast cancer, CEA in case of stomach cancer, CA19.9 in case of pancreatic cancer, CA125 in case of ovarian cancer.
    End point type
    Secondary
    End point timeframe
    T = 0 weeks, T = 1 week for every PIPAC
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: regression based on tumor marker
        number (not applicable)
    0
    0
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Pharmacodynamics (PD) of Abraxane Will be Analyzed by Tumour Biopsies

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    End point title
    		 Pharmacodynamics (PD) of Abraxane Will be Analyzed by Tumour Biopsies
    End point description
    Tumour samples will be collected (5x5x5 mm³) at the end of the aerosol delivery after each PIPAC procedure.
    End point type
    Secondary
    End point timeframe
    T = 30 minutes
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: regression based on PRGS
        number (not applicable)
    1
    1
    1
    1
    6
    No statistical analyses for this end point

    Secondary: Quality of Life (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30)

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    End point title
    		 Quality of Life (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30)
    End point description
    This will be investigated using the EORTC QLQ-C30 questionnaire. As to question 1 to 28: the scale varies from 1 (not at all) to 4 (very much). A higher value indicates a lower quality of life. The total score will be between 28 and 112. The scale of question 29 and 30 varies from 1 (very poor) to 7 (excellent). The higher the value, the better the quality of life. The total score will be between 2 and 14. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
    End point type
    Secondary
    End point timeframe
    Pre-operatively (every PIPAC), week 2 (every PIPAC) and, month 2 and month 6 (after the third PIPAC)
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: improved global health status after 6m
        number (not applicable)
    2
    0
    3
    3
    5
    No statistical analyses for this end point

    Secondary: Quality of Life (Functional Assessment of Cancer Therapy, FACT-G Questionnaire)

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    End point title
    		 Quality of Life (Functional Assessment of Cancer Therapy, FACT-G Questionnaire)
    End point description
    This will be investigated using the FACT-G questionnaire. The scale of all questions varies from 0 (not at all) to 4 (very much). The total score will be between 0 and 108. The lower the total score, the better the quality of life. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
    End point type
    Secondary
    End point timeframe
    Pre-operatively (every PIPAC), week 2 (every PIPAC) and, month 2 and month 6 (after the third PIPAC)
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: improved global health status after 6m
        number (not applicable)
    2
    0
    3
    3
    5
    No statistical analyses for this end point

    Secondary: Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

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    End point title
    		 Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
    End point description
    Blood samples will be collected to analyse the absolute neutrophil count
    End point type
    Secondary
    End point timeframe
    Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: participants
        CTCAE grade <=2
    0
    0
    1
    1
    4
        CTCAE grade >2
    0
    0
    0
    0
    1
        no neutropenia
    2
    2
    2
    2
    5
    No statistical analyses for this end point

    Secondary: Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

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    End point title
    		 Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
    End point description
    Blood samples will be collected to analyse the amount of platelets.
    End point type
    Secondary
    End point timeframe
    Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC
    End point values
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Number of subjects analysed
    2
    2
    3
    3
    10
    Units: Count of Participants
        CTCAE grade <=2
    0
    1
    1
    2
    3
        CTCAE grade >2
    0
    0
    1
    0
    0
        no thrombopenia
    2
    1
    1
    1
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Adverse event reporting additional description
    NA
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Abraxane 35 mg/m²
    Reporting group description
    		 -

    Reporting group title
    Abraxane 70 mg/m²
    Reporting group description
    		 -

    Reporting group title
    Abraxane 90 mg/m²
    Reporting group description
    		 -

    Reporting group title
    Abraxane 112.5 mg/m²
    Reporting group description
    		 -

    Reporting group title
    Abraxane 140 mg/m²
    Reporting group description
    		 -

    Serious adverse events
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    2 / 2 (100.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    6 / 10 (60.00%)
         number of deaths (all causes)
    1
    2
    1
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Surgical and medical procedures
    anaphylactic shock during surgery
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
         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
    surgical wound infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 10 (20.00%)
         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
    Blood and lymphatic system disorders
    thrombocytopenia grade 3 (CTCAE)
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 10 (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
    General disorders and administration site conditions
    anorexia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
         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
    progression peritoneal disease leading to death
         subjects affected / exposed
    1 / 2 (50.00%)
    2 / 2 (100.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    intestine obstruction
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (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
    Skin and subcutaneous tissue disorders
    Redness
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (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
    Infections and infestations
    infection peritoneum
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
         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: 0%
    Non-serious adverse events
    		 Abraxane 35 mg/m² Abraxane 70 mg/m² Abraxane 90 mg/m² Abraxane 112.5 mg/m² Abraxane 140 mg/m²
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    2 / 2 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    10 / 10 (100.00%)
    Vascular disorders
    hypertension
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    7 / 10 (70.00%)
         occurrences all number
    1
    1
    0
    1
    7
    Cardiac disorders
    electrocardiogram T wave abnormal
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Surgical and medical procedures
    bleeding at incision
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    surgical wound infection
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    4 / 10 (40.00%)
         occurrences all number
    1
    0
    1
    1
    4
    Nervous system disorders
    peripheral sensory neuropathy
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    0
    0
    0
    3
    Blood and lymphatic system disorders
    anemia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    9 / 10 (90.00%)
         occurrences all number
    0
    1
    2
    2
    9
    neutropenia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    5 / 10 (50.00%)
         occurrences all number
    0
    0
    1
    1
    5
    thrombopenia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    3 / 10 (30.00%)
         occurrences all number
    0
    1
    2
    2
    3
    white blood cell decreased
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    3 / 10 (30.00%)
         occurrences all number
    0
    0
    1
    2
    3
    General disorders and administration site conditions
    edema lower limbs
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Immune system disorders
    allergic reaction to anesthesia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    abdominal pain
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    0
    0
    0
    3
    adhesions
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    diarrhea
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    nausea
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    1
    2
    paralytic ileus
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    0
    1
    vomiting
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    bacterial pneumonia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    alopecia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    hyperhidrosis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    skin infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    Infections and infestations
    peritoneal infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    elevated ALP
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 2 (100.00%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    4 / 10 (40.00%)
         occurrences all number
    0
    2
    1
    2
    4
    elevated ALT
         subjects affected / exposed
    1 / 2 (50.00%)
    2 / 2 (100.00%)
    3 / 3 (100.00%)
    2 / 3 (66.67%)
    4 / 10 (40.00%)
         occurrences all number
    1
    2
    3
    2
    4
    elevated AST
         subjects affected / exposed
    2 / 2 (100.00%)
    2 / 2 (100.00%)
    3 / 3 (100.00%)
    2 / 3 (66.67%)
    6 / 10 (60.00%)
         occurrences all number
    2
    2
    3
    2
    6
    elevated GGT
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    7 / 10 (70.00%)
         occurrences all number
    1
    1
    0
    2
    7
    elevated bilirubin
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    1
    0
    2
    hyperglycemia
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    8 / 10 (80.00%)
         occurrences all number
    1
    1
    0
    1
    8
    hyperkalemia
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 2 (100.00%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    3 / 10 (30.00%)
         occurrences all number
    0
    2
    2
    1
    3
    hypernatremia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    hypokalemia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2018
    - The number of patients that will be included in University Hospital Ghent during phase I will be increased to (maximum) 20. Inclusion in the other participating centers (outside Belgium) is difficult, in contrast to the inclusion in University Hospital Ghent. Therefore, a maximum of approximately 20 patients will be included in University Hospital Ghent instead of the first 7 patients foreseen. The exact number will depend on eventual inclusion by the other participating centers. – Patients with breast cancer and upper GI cancer were added to the inclusion criteria. Literature demonstrates effectiveness of systemic administration of Abraxane in these types of tumors. – Patients for whom alternative systemic treatments are still an option were also added to the inclusion criteria. Offering our study only to patients without alternative systemic options (so-called end-of-treatment patients) will make inclusion enormously difficult, as this group of patients will then be in a virtually palliative setting, which means that they have insufficient life expectancy and are also physically too weak to undergo general anesthesia in combination with intraperitoneal administration to undergo. Parallel administration of chemotherapy containing a taxane (paclitaxel or docetaxel) is an exclusion criterion. – Consequently, we also like to change the title to: “Intraperitoneale aerosolvorming van albumine-gestabiliseerde paclitaxel nanopartikels (Abraxane®) voor de behandeling van buikvlieskanker: een fase I/II klinische studie” in Dutch and “Intraperitoneal aerosolisation of albumin-stabilized paclitaxel nanoparticles for peritoneal carcinomatosis – phase I/II study protocol” in English. – In addition, we would like to collect additional plasma samples from patients during phase I, in function of systemic toxicity assessment.

    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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