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    Clinical Trial Results:
    PARPi-PANC - A multicentric, single arm, phase II trial assessing the efficacy of niraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer

    Summary
    EudraCT number
    		 2021-003042-20
    Trial protocol
    		 FR  
    Global end of trial date
    06 Sep 2024

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ET21-169
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre Léon Bérard
    Sponsor organisation address
    28 Rue Laënnec, Lyon, France,
    Public contact
    DRCI - Phases précoces, Centre Léon Bérard, +33 (0)4 26 55 68 24,
    Scientific contact
    DRCI - Phases précoces, Centre Léon Bérard, +33 (0)4 26 55 68 24,
    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
    09 Feb 2026
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Sep 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the efficacy of niraparib in patients with HR-deficient pancreatic cancer.
    Protection of trial subjects
    No study-related procedure will be performed without prior written informed consent obtained from the patient. The investigator will inform the patient about the study treatment, its objectives, and its design, provide the patient information leaflet and informed consent form, answer any questions the patient may have, and ensure that the patient understands the potential risks and benefits of participating in the study before signing the informed consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Sep 2023
    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
    France: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    1
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inform the patient about the treatments, objectives, outcome and any ancillary studies, answer their questions and sign the informed consent with them after a reflection period . Check the eligibility criteria list and perform the exams (e.g. Physicial examination, baseline signs and symptoms...)

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

    Arms
    Arm title
    		 Single Arm
    Arm description
    		 Niraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer. Only patients with mutation and/or rearrangement leading to inactivation in at least one of the following genes BARD1, BRCA1, BRCA2, BRIP1, FANCA, FANCD2, FANCL, MRE11, NBN, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L are eligible.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Niraparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Per Os at approximately the same time every day, with or without a meal. Capsules should be swallowed whole with water. The capsules should not be chewed or crushed. Bedtime administration may be a potential method for managing nausea. Per Os at approximately the same time every day, with or without a meal. Capsules should be swallowed whole with water. The capsules should not be chewed or crushed. Bedtime administration may be a potential method for managing nausea. 300 mg/d, continuously for patients with TB >1.5- 3 ULN and/or ASAT/ALAT ≤5ULN. Or 200mg/d initial dosing for patients with TB >1.5 ULN and up to 3ULN and/or ASAT/ALAT > 2.5 ULN and up to 5 ULN with increase to 300mg if 1) liver safety lab tests improve to Grade 1 according to NCI criteria (based on total bilirubin and AST/ALT) with bilirubin <1.5ULN) and 2) no grade >1 related AE are reported.

    Number of subjects in period 1
    		Single Arm
    Started
    2
    Completed
    2

    Baseline characteristics

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

    Reporting group values
    		 Overall study period Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66 (56 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 Niraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer. Only patients with mutation and/or rearrangement leading to inactivation in at least one of the following genes BARD1, BRCA1, BRCA2, BRIP1, FANCA, FANCD2, FANCL, MRE11, NBN, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L are eligible.

    Primary: Objective response rate

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    End point title
    		 Objective response rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    The primary endpoint is the ORR after 16 weeks of treatment (ORR-16W) defined as the rate of patients with CR or PR as per RECIST V1.1.
    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: Only two patients were included, and the sponsor decided to prematurely terminate the study. Consequently, no analysis was performed.
    End point values
    		 Single Arm
    Number of subjects analysed
    2 [2]
    Units: number
        No evaluate
    2
    Notes
    [2] - Trial ended prematurely, no analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The investigator collects (spontaneous patient report or questionning) and immediately notifies the sponsor of all SAEs, in a written report, wether or not theay are deemed to be attributable to research and wich occur during the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only one adverse event was reported for this study: grade 3 vomiting related to treatment

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2022
    The addition of specific details regarding home blood pressure monitoring by the patient on days 8, 22, 8, and 22 impacts the information sheet. The addition of instructions and a record of these home blood pressure measurements in the home monitoring logbook.
    13 Mar 2023
    The removal of the requirement for biallelic inactivation of one of the homologous recombination genes (criterion I3 & study design). The ability to document an alteration of one of the homologous recombination genes using liquid biopsy (addition of a mandatory blood sample for screening, study design). Collection of an archived tumor sample remains required for the ancillary program.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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