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    Clinical Trial Results:
    A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration- Resistant Prostate Cancer and DNA-Repair Anomalies

    Summary
    EudraCT number
    		 2016-002057-38
    Trial protocol
    		 SE   GB   ES   BE   DK   NL   FR   IT  
    Global end of trial date
    16 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2024
    First version publication date
    23 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    64091742PCR2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02854436
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International BV
    Sponsor organisation address
    Antwerpseweg 15-17, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International BV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International BV, ClinicalTrialsEU@its.jnj.com
    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
    26 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to assess the efficacy of niraparib in subjects with measurable metastatic castration-resistant prostate cancer (mCRPC) and who had either biallelic deoxyribonucleic acid repair anomalies in breast cancer gene (BRCA; BRCA1 or BRCA2) or germline BRCA.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Aug 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 31
    Country: Number of subjects enrolled
    Belgium: 18
    Country: Number of subjects enrolled
    Brazil: 12
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    Spain: 39
    Country: Number of subjects enrolled
    France: 48
    Country: Number of subjects enrolled
    United Kingdom: 17
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Sweden: 24
    Country: Number of subjects enrolled
    Taiwan: 9
    Country: Number of subjects enrolled
    United States: 45
    Worldwide total number of subjects
    289
    EEA total number of subjects
    136
    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)
    84
    From 65 to 84 years
    198
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 For long-term extension (LTE) phase, as pre planned in the protocol no efficacy analysis was performed. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Niraparib
    Arm description
    		 Male subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator’s discretion until no benefits from treatment or Sponsor’s decision.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-64091742
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received niraparib 300mg (3 capsule of 100 mg) once daily.

    Number of subjects in period 1
    		Niraparib
    Started
    289
    Completed
    0
    Not completed
    289
         Adverse event, serious fatal
    208
         Physician decision
    6
         Consent withdrawn by subject
    24
         Adverse event, non-fatal
    1
         Unspecified
    45
         Lost to follow-up
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Niraparib
    Reporting group description
    		 Male subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator’s discretion until no benefits from treatment or Sponsor’s decision.

    Reporting group values
    		 Niraparib Total
    Number of subjects
    		 289 289
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 84 84
        From 65 to 84 years
    		 198 198
        85 years and over
    		 7 7
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.8 ( 7.8 ) -
    Title for Gender
    Units: subjects
        Male
    		 289 289
        Female
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Niraparib
    Reporting group description
    		 Male subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator’s discretion until no benefits from treatment or Sponsor’s decision.

    Primary: Objective Response Rate (ORR) for Subjects with Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation

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    End point title
    		 Objective Response Rate (ORR) for Subjects with Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation [1]
    End point description
    ORR defined as percentage of subjects with BRCA DNA-repair anomalies and measurable disease whose best response is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and with no evidence of bone progression per Prostate Cancer Working Group 3 (PCWG3) criteria. Measurable intent to treat (ITT) population also referred to as efficacy analysis set included all subjects who received at least 1 dose of study drug and had BRCA (biallelic or germline DNA-repair anomalies) and measurable disease at baseline.
    End point type
    Primary
    End point timeframe
    Up to 52 months
    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: No inferential statistics was done. Only descriptive statistics was performed.
    End point values
    		 Niraparib
    Number of subjects analysed
    76
    Units: percentage of subjects
        number (confidence interval 95%)
    34.2 (23.7 to 46.0)
    No statistical analyses for this end point

    Secondary: Objective Response Rate for Subjects with Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation

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    End point title
    		 Objective Response Rate for Subjects with Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation
    End point description
    ORR defined as percentage of subjects with BRCA deoxyribonucleic acid (DNA)-repair anomalies and measurable disease whose best response is either CR or PR per RECIST 1.1 and with no evidence of bone progression per PCWG3 criteria. Measurable ITT analysis set included all subjects who received at least 1 dose of study drug and had non-BRCA (biallelic DNA-repair anomaly) and measurable disease at baseline.
    End point type
    Secondary
    End point timeframe
    Up to 52 months
    End point values
    		 Niraparib
    Number of subjects analysed
    47
    Units: percentage of subjects
        number (confidence interval 95%)
    10.6 (3.5 to 23.1)
    No statistical analyses for this end point

    Secondary: Circulating Tumor Cells (CTC) Response Rate

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    End point title
    		 Circulating Tumor Cells (CTC) Response Rate
    End point description
    CTC response rate was defined as the percentage of subjects with CTC equals to (=) 0 per 7.5 millilitres (mL) blood at 8 weeks post-baseline in subjects with baseline CTC greater than (>) 0. ITT analysis set included all subjects who received at least 1 dose of study drug. Here 'N' (number of subjects analysed) specifies the subjects with baseline CTC (per 7.5 mL blood) > 0. Here, 'n' (number analysed) specifies the number of subjects evaluated for specific categories.
    End point type
    Secondary
    End point timeframe
    At 8 weeks post-baseline
    End point values
    		 Niraparib
    Number of subjects analysed
    202
    Units: percentage of subjects
    number (not applicable)
        BRCA (n=131)
    23.7
        Non-BRCA (n=71)
    8.5
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as time from enrollment to death from any cause. ITT analysis set included subjects who had received at least 1 dose of study drug. Here, 'n' (number analysed) specifies the number of subjects evaluated for specific categories.
    End point type
    Secondary
    End point timeframe
    Up to 52 months
    End point values
    		 Niraparib
    Number of subjects analysed
    223
    Units: months
    median (confidence interval 95%)
        BRCA (n=142)
    13.01 (11.04 to 14.29)
        Non-BRCA (n=81)
    9.63 (8.05 to 13.44)
    No statistical analyses for this end point

    Secondary: Radiographic Progression-Free Survival (rPFS)

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    End point title
    		 Radiographic Progression-Free Survival (rPFS)
    End point description
    rPFS was defined as time from enrollment to radiographic progression or death from any cause, whichever occurred first. Radiographic progression was evaluated per RECIST 1.1 criteria for soft tissue disease and per PCWG3 criteria for bone disease. ITT analysis set included subjects who had received at least 1 dose of study drug. Here, 'n' (number analysed) specifies the number of subjects evaluated for specific categories.
    End point type
    Secondary
    End point timeframe
    Up to 52 months
    End point values
    		 Niraparib
    Number of subjects analysed
    223
    Units: months
    median (confidence interval 95%)
        BRCA (n= 142)
    8.08 (5.55 to 8.38)
        Non-BRCA (n=81)
    3.71 (1.97 to 5.49)
    No statistical analyses for this end point

    Secondary: Time to Radiographic Progression

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    End point title
    		 Time to Radiographic Progression
    End point description
    Time to radiographic progression is defined as time from enrollment to radiographic progression or death due to disease progression, whichever occurs first. Disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that was smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. ITT analysis set included subjects who had received at least 1 dose of study drug. Here, 'n' (number analysed) specifies the number of subjects evaluated for specific categories.
    End point type
    Secondary
    End point timeframe
    Up to 52 months
    End point values
    		 Niraparib
    Number of subjects analysed
    223
    Units: months
    median (confidence interval 95%)
        BRCA (n=142)
    8.08 (5.75 to 8.97)
        Non-BRCA (n=81)
    3.78 (2.00 to 5.55)
    No statistical analyses for this end point

    Secondary: Time to Prostate-Specific Antigen (PSA) Progression

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    End point title
    		 Time to Prostate-Specific Antigen (PSA) Progression
    End point description
    Time to PSA progression was defined as time from enrollment to the first date of documented PSA progression based on PCWG3 criteria. A subjects was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanograms per millilitre (ng/mL) or more, which was confirmed by a second value obtained in 3 or more weeks. ITT analysis set included subjects who had received at least 1 dose of study drug. Here, 'n' (number analysed) specifies the number of subjects evaluated for specific categories.
    End point type
    Secondary
    End point timeframe
    Up to 52 months
    End point values
    		 Niraparib
    Number of subjects analysed
    223
    Units: months
    median (confidence interval 95%)
        BRCA (n=142)
    5.13 (4.60 to 5.59)
        Non-BRCA (n=81)
    3.65 (2.83 to 3.71)
    No statistical analyses for this end point

    Secondary: Time to Symptomatic Skeletal Event (SSE)

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    End point title
    		 Time to Symptomatic Skeletal Event (SSE)
    End point description
    Time to SSE was defined as the time from enrollment to first occurrence of one of the following symptomatic skeletal events: tumor-related spinal cord compression, radiation to bone to relieve skeletal symptoms, surgery to bone or need for tumor-related orthopedic surgical intervention, symptomatic or pathologic fracture. ITT analysis set included subjects who had received at least 1 dose of study drug. Here, 'n' (number analysed) specifies the number of subjects evaluated for specific categories. Here, 99999 indicates that upper limit of 95% confidence interval (CI) was not estimable due to less number of events.
    End point type
    Secondary
    End point timeframe
    Up to 52 months
    End point values
    		 Niraparib
    Number of subjects analysed
    223
    Units: months
    median (confidence interval 95%)
        BRCA (n=142)
    13.80 (10.41 to 99999)
        Non-BRCA (n=81)
    10.35 (8.18 to 99999)
    No statistical analyses for this end point

    Secondary: Duration of Objective Response

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    End point title
    		 Duration of Objective Response
    End point description
    Duration of objective response is defined as time from CR or PR to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first. Unequivocal clinical progression defined as one or more of following: 1) deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS) to Grade 3 or higher; 2) initiated any of following because of tumor progression (even in absence of radiographic evidence of disease): alternative anticancer therapy for prostate cancer, radiation therapy, surgical interventions for complications due to tumor progression. Measurable ITT responder analysis set included all subjects who received at least 1 dose of study drug, responded to it and have BRCA or non-BRCA and measurable disease at baseline. Here, 'n' (number analysed) specifies the number of subjects evaluated for specificed categories. Here, '99999' indicates that upper limit of 95% CI was not estimable due to less number of events.
    End point type
    Secondary
    End point timeframe
    Up to 52 months
    End point values
    		 Niraparib
    Number of subjects analysed
    31
    Units: months
    median (confidence interval 95%)
        BRCA (n=26)
    5.55 (3.91 to 7.20)
        non-BRCA (n=5)
    5.16 (2.14 to 99999)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events (AEs)

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    End point title
    		 Number of Subjects with Adverse Events (AEs)
    End point description
    An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Safety analysis set included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to 52 months
    End point values
    		 Niraparib
    Number of subjects analysed
    289
    Units: Subjects
    288
    No statistical analyses for this end point

    Secondary: Number of Subjects with Worst Toxicity Grades for Clinical Laboratory Tests based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)

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    End point title
    		 Number of Subjects with Worst Toxicity Grades for Clinical Laboratory Tests based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    End point description
    Number of subjects with worst toxicity grades for clinical laboratory tests (chemistry and hematology) based on NCI-CTCAE were reported. The chemistry laboratory parameters were: alanine aminotransferase (ALT) increased, alkaline phosphatase (AP) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine increased, gamma glutamyl transferase (GGT) increased and the hematology parameters were: hemoglobin increased, lymphocyte count increased. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). Safety analysis set included all subjects who received at least 1 dose of study drug and with at least one postbaseline assessment for the specific lab test within the time period. Here, 'n' (number analysed) specifies the number of subjects evaluated for specified categories.
    End point type
    Secondary
    End point timeframe
    Up to 52 months
    End point values
    		 Niraparib
    Number of subjects analysed
    283
    Units: subjects
        ALT increased (Grade 1 or 2) (n=283)
    67
        ALT increased (Grade 3 or 4) (n=283)
    4
        AP increased (Grade 1 or 2) (n=283)
    102
        AP increased (Grade 3 or 4) (n=283)
    7
        AST increased (Grade 1 or 2) (n=283)
    70
        AST increased (Grade 3 or 4) (n=283)
    4
        Blood bilirubin increased (Grade 1 or 2) (n=283)
    9
        Blood bilirubin increased (Grade 3 or 4) (n=283)
    2
        Creatinine increased (Grade 1 or 2) (n=283)
    45
        Creatinine increased (Grade 3 or 4) (n=283)
    2
        GGT increased (Grade 1 or 2) (n=282)
    105
        GGT increased (Grade 3 or 4) (n=282)
    14
        Hemoglobin increased (Grade 1 or 2) (n=283)
    0
        Hemoglobin increased (Grade 3 or 4) (n=283)
    0
        Lymphocyte count increased (Grade 1 or 2) (n=283)
    6
        Lymphocyte count increased (Grade 3 or 4) (n=283)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 52 months.
    Adverse event reporting additional description
    Safety analysis set included all subjects who received at least 1 dose of study drug. Due to change in the conduct of the study, no adverse events data were collected and thus no adverse event data were reported for the LTE phase.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Niraparib
    Reporting group description
    		 Male Subjects who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months). After completion of treatment phase, subjects were offered entry into the long-term extension (LTE) phase (which was planned as per protocol amendment 8, dated 17-Jul-2020) with a separate informed consent and to continue treatment per the investigator’s discretion until no benefits from treatment or Sponsor’s decision.

    Serious adverse events
    		 Niraparib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    134 / 289 (46.37%)
         number of deaths (all causes)
    208
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal Stromal Tumour
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastases to Meninges
         subjects affected / exposed
    3 / 289 (1.04%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Prostate Cancer Metastatic
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Tumour Pain
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Systemic Inflammatory Response Syndrome
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    4 / 289 (1.38%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Performance Status Decreased
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    8 / 289 (2.77%)
         occurrences causally related to treatment / all
    1 / 8
         deaths causally related to treatment / all
    0 / 4
    Facial Pain
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Asthenia
         subjects affected / exposed
    4 / 289 (1.38%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    4 / 289 (1.38%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung Disorder
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Distress
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional State
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Blood Calcium Increased
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Extradural Haematoma
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur Fracture
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hip Fracture
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cystitis Radiation
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Ventricular Tachycardia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac Failure
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Cardiac Arrest
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Atrial Fibrillation
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Altered State of Consciousness
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cauda Equina Syndrome
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    6 / 289 (2.08%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Monoparesis
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nerve Compression
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neuropathy Peripheral
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraparesis
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    6 / 289 (2.08%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    17 / 289 (5.88%)
         occurrences causally related to treatment / all
    17 / 18
         deaths causally related to treatment / all
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Anaemia
         subjects affected / exposed
    13 / 289 (4.50%)
         occurrences causally related to treatment / all
    8 / 15
         deaths causally related to treatment / all
    0 / 1
    Leukopenia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    7 / 289 (2.42%)
         occurrences causally related to treatment / all
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stomatitis
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    5 / 289 (1.73%)
         occurrences causally related to treatment / all
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inflammatory Bowel Disease
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    5 / 289 (1.73%)
         occurrences causally related to treatment / all
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Acute Abdomen
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    4 / 289 (1.38%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    6 / 289 (2.08%)
         occurrences causally related to treatment / all
    2 / 8
         deaths causally related to treatment / all
    0 / 1
    Renal Impairment
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Retention
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 289 (1.04%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Back Pain
         subjects affected / exposed
    7 / 289 (2.42%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Bone Pain
         subjects affected / exposed
    3 / 289 (1.04%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Joint Effusion
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    3 / 289 (1.04%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in Extremity
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in Jaw
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Septic Shock
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Skin Infection
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal Cord Infection
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    3 / 289 (1.04%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    5 / 289 (1.73%)
         occurrences causally related to treatment / all
    2 / 7
         deaths causally related to treatment / all
    1 / 2
    Pyelonephritis Acute
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Haemophilus
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 289 (1.38%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Pneumocystis Jirovecii Pneumonia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Neutropenic Sepsis
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Malaria
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infected Lymphocele
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess Jaw
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal Infection
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    1 / 1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    4 / 289 (1.38%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hypokalaemia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 289 (0.69%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 289 (0.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Niraparib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    280 / 289 (96.89%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    17 / 289 (5.88%)
         occurrences all number
    25
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    20 / 289 (6.92%)
         occurrences all number
    27
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    26 / 289 (9.00%)
         occurrences all number
    35
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    17 / 289 (5.88%)
         occurrences all number
    23
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    25 / 289 (8.65%)
         occurrences all number
    38
    Weight Decreased
         subjects affected / exposed
    50 / 289 (17.30%)
         occurrences all number
    61
    Vascular disorders
    Hot Flush
         subjects affected / exposed
    17 / 289 (5.88%)
         occurrences all number
    19
    Hypertension
         subjects affected / exposed
    34 / 289 (11.76%)
         occurrences all number
    47
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    17 / 289 (5.88%)
         occurrences all number
    18
    Dizziness
         subjects affected / exposed
    19 / 289 (6.57%)
         occurrences all number
    20
    Headache
         subjects affected / exposed
    30 / 289 (10.38%)
         occurrences all number
    40
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    154 / 289 (53.29%)
         occurrences all number
    472
    Leukopenia
         subjects affected / exposed
    27 / 289 (9.34%)
         occurrences all number
    57
    Lymphopenia
         subjects affected / exposed
    24 / 289 (8.30%)
         occurrences all number
    42
    Neutropenia
         subjects affected / exposed
    54 / 289 (18.69%)
         occurrences all number
    114
    Thrombocytopenia
         subjects affected / exposed
    94 / 289 (32.53%)
         occurrences all number
    270
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    45 / 289 (15.57%)
         occurrences all number
    73
    Fatigue
         subjects affected / exposed
    105 / 289 (36.33%)
         occurrences all number
    163
    Oedema Peripheral
         subjects affected / exposed
    41 / 289 (14.19%)
         occurrences all number
    48
    Pyrexia
         subjects affected / exposed
    17 / 289 (5.88%)
         occurrences all number
    19
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    23 / 289 (7.96%)
         occurrences all number
    28
    Constipation
         subjects affected / exposed
    98 / 289 (33.91%)
         occurrences all number
    125
    Diarrhoea
         subjects affected / exposed
    48 / 289 (16.61%)
         occurrences all number
    66
    Dry Mouth
         subjects affected / exposed
    20 / 289 (6.92%)
         occurrences all number
    20
    Dyspepsia
         subjects affected / exposed
    21 / 289 (7.27%)
         occurrences all number
    24
    Nausea
         subjects affected / exposed
    167 / 289 (57.79%)
         occurrences all number
    256
    Stomatitis
         subjects affected / exposed
    19 / 289 (6.57%)
         occurrences all number
    28
    Vomiting
         subjects affected / exposed
    109 / 289 (37.72%)
         occurrences all number
    175
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    39 / 289 (13.49%)
         occurrences all number
    50
    Cough
         subjects affected / exposed
    17 / 289 (5.88%)
         occurrences all number
    21
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    24 / 289 (8.30%)
         occurrences all number
    28
    Musculoskeletal and connective tissue disorders
    Pain in Extremity
         subjects affected / exposed
    30 / 289 (10.38%)
         occurrences all number
    35
    Musculoskeletal Pain
         subjects affected / exposed
    29 / 289 (10.03%)
         occurrences all number
    37
    Bone Pain
         subjects affected / exposed
    30 / 289 (10.38%)
         occurrences all number
    42
    Arthralgia
         subjects affected / exposed
    43 / 289 (14.88%)
         occurrences all number
    76
    Back Pain
         subjects affected / exposed
    59 / 289 (20.42%)
         occurrences all number
    78
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    93 / 289 (32.18%)
         occurrences all number
    130

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2016
    The purpose of the study amendment was the overall reason for the amendment is to address feedback from FDA received 5 July 2016. ECG monitoring at every cycle was added due to FDA concern regarding higher ECG abnormalities in the elderly population. FDA recommendation that toxicities which have not resolved within 21 days should undergo dose reduction or discontinuation. FDA recommendation that a hematologist must be consulted in the event of greater than (>) 1 transfusion or that did not recover to Grade 1 or less after 28 days.
    25 Jan 2017
    The purpose of the study amendment was primary endpoint of the study was amended to comply with feedback from health authorities. The primary endpoint was changed from a composite endpoint to objective response rate (ORR). With this change, the subject population for the primary analysis will include only subjects with measurable disease. Subjects with non-measurable disease will still be included in the study to increase the size of the safety database and assess the activity of niraparib in this population.
    04 Oct 2017
    The purpose of the study amendment was to include additional cardiac monitoring to better understand the cardiovascular effect of niraparib monotherapy in the prostate cancer population. This additional safety monitoring is precautionary only and is not indicative of a known cardiac signal for niraparib. An ITT Population was also added to allow for all subjects with biallelic DNA-repair anomalies to be analyzed separately for efficacy. Other minor changes (ie, removal of pharmacodynamics sampling and updates to the inclusion/exclusion criteria) are also included in this amendment.
    20 Mar 2018
    The purpose of the study amendment was to improve the subject selection criteria based on using an enhanced biomarker assay and the corresponding statistical analysis plan, to remove Holter monitoring, and other minor changes throughout the protocol.
    30 Nov 2018
    The purpose of the study amendment was based on the updated safety information of niraparib with more subjects exposed to drug and to be consistent with clinical practice of physicians, changes were made to inclusion/exclusion criteria and other study-related procedures throughout the protocol.
    20 Jun 2019
    The purpose of the study amendment was to modify and clarify the protocol’s inclusion and exclusion criteria to align with current clinical practice for the treatment of patients with metastatic prostate cancer based on protocol steering committee feedback and to reflect the characteristics of the third line mCRPC population.
    30 Oct 2019
    The purpose of the study amendment was to allow subjects with local germline pathogenic results for Breast Cancer gene 1 (BRCA1) or Breast Cancer gene 2 (BRCA2) DNA-repair defects (DRD) to enter the trial given the high likelihood of biallelic mutations.
    17 Apr 2020
    The purpose of the study amendment was to provide study-related guidance during the global coronavirus (COVID-19) pandemic. For health and safety reasons, subjects may not be able to come to the study site for scheduled procedures.
    17 Jul 2020
    The purpose of the study amendment was (1) to add a Long-term Extension Phase, (2) to include subjects who have germline pathogenic Non-Breast Cancer Gene 1 or Breast Cancer gene 2 (BRCA1 or BRCA2) mutations in the efficacy analyses, and (3) to provide updated patient enrollment recruitment requirements.

    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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