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    Clinical Trial Results:
    A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

    Summary
    EudraCT number
    		 2017-003493-13
    Trial protocol
    		 GB   ES   HU   BE   PL   CZ  
    Global end of trial date
    03 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Sep 2023
    First version publication date
    09 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BGB-290-303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03427814
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BeiGene
    Sponsor organisation address
    1840 Gateway Drive, San Mateo, CA , United States, 94404
    Public contact
    Clinical Trial Information Email, BeiGene Ltd., +1 781801 1800, clinicaltrials@beigene.com
    Scientific contact
    Clinical Trial Information Email, BeiGene Ltd., +1 781801 1800, clinicaltrials@beigene.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
    03 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of maintenance therapy with BGB-290 versus placebo in patients with inoperable locally advanced or metastatic gastric cancer with a complete response (CR) or confirmed partial response (PR) after first-line platinum-based chemotherapy, as measured by: Progression-free survival (PFS) by Investigator
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and in accordance with BeiGene procedures, which comply with the principles of GCP, International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use guidelines, the Declaration of Helsinki, and local regulatory requirements
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jul 2018
    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
    Poland: 4
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Czechia: 1
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    China: 19
    Country: Number of subjects enrolled
    Georgia: 2
    Country: Number of subjects enrolled
    Hong Kong: 1
    Country: Number of subjects enrolled
    Japan: 11
    Country: Number of subjects enrolled
    Russian Federation: 29
    Country: Number of subjects enrolled
    Singapore: 1
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United States: 11
    Worldwide total number of subjects
    136
    EEA total number of subjects
    51
    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)
    74
    From 65 to 84 years
    61
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled in multiple study centers in Asia, Australia, Europe, and North America.

    Pre-assignment
    Screening details
    		 Screening period was -28 to -1 days prior to first dose

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pamiparib
    Arm description
    		 Participants received 60 milligrams (mg) pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator’s discretion, start of new anticancer therapy, or Sponsor's decision to end the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60 milligrams (mg) orally, twice daily

    Arm title
    		 Placebo
    Arm description
    		 Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator’s discretion, start of new anticancer therapy, or Sponsor's decision to end the study
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg placebo orally twice daily

    Number of subjects in period 1
    		Pamiparib Placebo
    Started
    71
    65
    Completed
    0
    0
    Not completed
    71
    65
         Consent withdrawn by subject
    4
    4
         Sponsor's Decision
    1
    -
         Investigator's Decision
    1
    2
         Death
    42
    31
         Treatment Completed
    -
    1
         Sponsor's Decision to End Study
    21
    25
         Transfer to Long Term Extension
    1
    -
         Lost to follow-up
    -
    2
         Disease Progression
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pamiparib
    Reporting group description
    		 Participants received 60 milligrams (mg) pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator’s discretion, start of new anticancer therapy, or Sponsor's decision to end the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator’s discretion, start of new anticancer therapy, or Sponsor's decision to end the study

    Reporting group values
    		 Pamiparib Placebo Total
    Number of subjects
    		 71 65 136
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.5 ( 9.8 ) 62.1 ( 11.23 ) -
    Gender categorical
    Units: Subjects
        Female
    		 25 20 45
        Male
    		 46 45 91

    End points

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    End points reporting groups
    Reporting group title
    Pamiparib
    Reporting group description
    		 Participants received 60 milligrams (mg) pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator’s discretion, start of new anticancer therapy, or Sponsor's decision to end the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator’s discretion, start of new anticancer therapy, or Sponsor's decision to end the study

    Primary: Progression Free Survival (PFS) by Investigator Assessment

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    End point title
    		 Progression Free Survival (PFS) by Investigator Assessment
    End point description
    PFS, is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first. Intent-To-Treat (ITT) Analysis Set is defined as all randomized subjects who are assigned to study drug (pamiparib or placebo).
    End point type
    Primary
    End point timeframe
    Approximately 23 months
    End point values
    		 Pamiparib Placebo
    Number of subjects analysed
    71
    65
    Units: Months
        median (confidence interval 95%)
    3.7 (1.94 to 5.26)
    2.1 (1.87 to 3.75)
    Statistical analysis title
    		 Satirical analysis 1
    Comparison groups
    Pamiparib v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1428 [1]
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - The one-sided p-value was based on a stratified log-rank test.

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as the time from randomization to death due to any cause. ITT Analysis Set
    End point type
    Secondary
    End point timeframe
    Approximately 23 months
    End point values
    		 Pamiparib Placebo
    Number of subjects analysed
    71
    65 [2]
    Units: Months
        median (confidence interval 95%)
    10.2 (8.71 to 16.33)
    12.0 (8.21 to 9999)
    Notes
    [2] - 9999 = Not Estimable due to insufficient number of events
    No statistical analyses for this end point

    Secondary: Time To Second Subsequent Treatment (TSST)

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    End point title
    		 Time To Second Subsequent Treatment (TSST)
    End point description
    TSST is defined as the time from randomization until the second subsequent anticancer therapy or death after next-line therapy. ITT Analysis Set
    End point type
    Secondary
    End point timeframe
    Approximately 23 months
    End point values
    		 Pamiparib Placebo
    Number of subjects analysed
    71
    65
    Units: Months
        median (confidence interval 95%)
    9.8 (8.05 to 10.94)
    9.7 (7.49 to 14.00)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR is defined as the percentage of participants with a best overall response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment Efficacy Evaluable Analysis Set includes all randomized participants who had measurable disease at baseline and had at least one post baseline tumor assessment unless discontinued treatment due to clinical progression or death prior to tumor assessment
    End point type
    Secondary
    End point timeframe
    Approximately 23 months
    End point values
    		 Pamiparib Placebo
    Number of subjects analysed
    39
    32
    Units: Percentage of participants
        number (confidence interval 95%)
    7.7 (1.62 to 20.87)
    6.3 (0.77 to 20.81)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR, is defined as the time from the first documented confirmed response of CR or PR to progressive disease (PD) per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first. Efficacy Evaluable Analysis Set; Only responders were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Approximately 23 months
    End point values
    		 Pamiparib Placebo
    Number of subjects analysed
    3 [3]
    2 [4]
    Units: Months
        median (confidence interval 95%)
    3.6 (3.48 to 9999)
    9999 (5.55 to 9999)
    Notes
    [3] - 9999 = Not estimable due to insufficient number of events
    [4] - 9999 = Not estimable due to insufficient number of events
    No statistical analyses for this end point

    Secondary: Time To Response

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    End point title
    		 Time To Response
    End point description
    Time to response is defined as the time from randomization to the first documented response of CR or PR per RECIST Version 1.1 by investigator assessment. Efficacy Evaluable Analysis Set; Only responders were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Approximately 23 months
    End point values
    		 Pamiparib Placebo
    Number of subjects analysed
    3
    2
    Units: Months
        median (confidence interval 95%)
    3.68 (1.8 to 7.3)
    1.87 (1.87 to 1.9)
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    End point description
    Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
    End point type
    Secondary
    End point timeframe
    From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
    End point values
    		 Pamiparib Placebo
    Number of subjects analysed
    71
    65
    Units: Number of participants
        Participant With At Least 1 TEAE
    66
    61
        Participants with Serious TEAEs
    17
    11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator’s discretion, start of new anticancer therapy, or Sponsor's decision to end the study

    Reporting group title
    Pamiparib 60 mg BID
    Reporting group description
    		 Participants received 60 milligrams (mg) pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator’s discretion, start of new anticancer therapy, or Sponsor's decision to end the study.

    Serious adverse events
    		 Placebo Pamiparib 60 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 65 (16.92%)
    17 / 71 (23.94%)
         number of deaths (all causes)
    31
    42
         number of deaths resulting from adverse events
    2
    3
    Investigations
    Platelet count decreased
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hepatic rupture
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 65 (1.54%)
    3 / 71 (4.23%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 71 (2.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    General physical health deterioration
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    3 / 65 (4.62%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant dysphagia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 71 (2.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postrenal failure
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumocystis jirovecii infection
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 71 (2.82%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo Pamiparib 60 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 65 (87.69%)
    65 / 71 (91.55%)
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    4 / 65 (6.15%)
    6 / 71 (8.45%)
         occurrences all number
    6
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 65 (7.69%)
    9 / 71 (12.68%)
         occurrences all number
    6
    11
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 65 (7.69%)
    8 / 71 (11.27%)
         occurrences all number
    6
    9
    Blood bilirubin increased
         subjects affected / exposed
    1 / 65 (1.54%)
    3 / 71 (4.23%)
         occurrences all number
    2
    4
    Blood creatinine increased
         subjects affected / exposed
    2 / 65 (3.08%)
    5 / 71 (7.04%)
         occurrences all number
    2
    5
    Platelet count decreased
         subjects affected / exposed
    2 / 65 (3.08%)
    8 / 71 (11.27%)
         occurrences all number
    3
    10
    Neutrophil count decreased
         subjects affected / exposed
    3 / 65 (4.62%)
    7 / 71 (9.86%)
         occurrences all number
    4
    17
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 65 (1.54%)
    4 / 71 (5.63%)
         occurrences all number
    3
    4
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    3 / 65 (4.62%)
    4 / 71 (5.63%)
         occurrences all number
    3
    4
    Weight increased
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    White blood cell count decreased
         subjects affected / exposed
    3 / 65 (4.62%)
    8 / 71 (11.27%)
         occurrences all number
    6
    16
    Weight decreased
         subjects affected / exposed
    2 / 65 (3.08%)
    9 / 71 (12.68%)
         occurrences all number
    2
    9
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 65 (3.08%)
    2 / 71 (2.82%)
         occurrences all number
    3
    3
    Hypotension
         subjects affected / exposed
    0 / 65 (0.00%)
    5 / 71 (7.04%)
         occurrences all number
    0
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 65 (0.00%)
    3 / 71 (4.23%)
         occurrences all number
    0
    3
    Headache
         subjects affected / exposed
    2 / 65 (3.08%)
    2 / 71 (2.82%)
         occurrences all number
    2
    2
    Dysgeusia
         subjects affected / exposed
    2 / 65 (3.08%)
    6 / 71 (8.45%)
         occurrences all number
    2
    6
    Paraesthesia
         subjects affected / exposed
    3 / 65 (4.62%)
    1 / 71 (1.41%)
         occurrences all number
    4
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    9 / 65 (13.85%)
    4 / 71 (5.63%)
         occurrences all number
    10
    4
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 65 (1.54%)
    3 / 71 (4.23%)
         occurrences all number
    1
    5
    Lymphopenia
         subjects affected / exposed
    0 / 65 (0.00%)
    4 / 71 (5.63%)
         occurrences all number
    0
    4
    Neutropenia
         subjects affected / exposed
    3 / 65 (4.62%)
    5 / 71 (7.04%)
         occurrences all number
    4
    8
    Thrombocytopenia
         subjects affected / exposed
    5 / 65 (7.69%)
    4 / 71 (5.63%)
         occurrences all number
    7
    7
    Anaemia
         subjects affected / exposed
    10 / 65 (15.38%)
    25 / 71 (35.21%)
         occurrences all number
    12
    31
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    12 / 65 (18.46%)
    16 / 71 (22.54%)
         occurrences all number
    12
    16
    Chest pain
         subjects affected / exposed
    0 / 65 (0.00%)
    3 / 71 (4.23%)
         occurrences all number
    0
    5
    Fatigue
         subjects affected / exposed
    4 / 65 (6.15%)
    4 / 71 (5.63%)
         occurrences all number
    4
    4
    Pyrexia
         subjects affected / exposed
    1 / 65 (1.54%)
    6 / 71 (8.45%)
         occurrences all number
    1
    6
    Oedema peripheral
         subjects affected / exposed
    4 / 65 (6.15%)
    5 / 71 (7.04%)
         occurrences all number
    4
    5
    Malaise
         subjects affected / exposed
    2 / 65 (3.08%)
    4 / 71 (5.63%)
         occurrences all number
    2
    4
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 65 (4.62%)
    4 / 71 (5.63%)
         occurrences all number
    3
    5
    Dysphagia
         subjects affected / exposed
    7 / 65 (10.77%)
    3 / 71 (4.23%)
         occurrences all number
    7
    3
    Diarrhoea
         subjects affected / exposed
    9 / 65 (13.85%)
    13 / 71 (18.31%)
         occurrences all number
    10
    21
    Constipation
         subjects affected / exposed
    9 / 65 (13.85%)
    9 / 71 (12.68%)
         occurrences all number
    9
    13
    Abdominal pain upper
         subjects affected / exposed
    7 / 65 (10.77%)
    12 / 71 (16.90%)
         occurrences all number
    7
    13
    Abdominal pain
         subjects affected / exposed
    13 / 65 (20.00%)
    9 / 71 (12.68%)
         occurrences all number
    14
    9
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 65 (4.62%)
    4 / 71 (5.63%)
         occurrences all number
    3
    4
    Stomatitis
         subjects affected / exposed
    3 / 65 (4.62%)
    3 / 71 (4.23%)
         occurrences all number
    3
    4
    Odynophagia
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 71 (1.41%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    12 / 65 (18.46%)
    23 / 71 (32.39%)
         occurrences all number
    14
    26
    Vomiting
         subjects affected / exposed
    2 / 65 (3.08%)
    16 / 71 (22.54%)
         occurrences all number
    2
    17
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 65 (3.08%)
    3 / 71 (4.23%)
         occurrences all number
    2
    3
    Dysphonia
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea
         subjects affected / exposed
    2 / 65 (3.08%)
    2 / 71 (2.82%)
         occurrences all number
    2
    2
    Rhinorrhoea
         subjects affected / exposed
    3 / 65 (4.62%)
    0 / 71 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    Onycholysis
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Dry skin
         subjects affected / exposed
    0 / 65 (0.00%)
    3 / 71 (4.23%)
         occurrences all number
    0
    3
    Pruritus
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 65 (7.69%)
    3 / 71 (4.23%)
         occurrences all number
    5
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 65 (4.62%)
    7 / 71 (9.86%)
         occurrences all number
    3
    8
    Myalgia
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 71 (1.41%)
         occurrences all number
    2
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Muscle spasms
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 71 (1.41%)
         occurrences all number
    2
    1
    Back pain
         subjects affected / exposed
    7 / 65 (10.77%)
    3 / 71 (4.23%)
         occurrences all number
    7
    3
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 65 (3.08%)
    4 / 71 (5.63%)
         occurrences all number
    3
    5
    Pneumonia
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 65 (13.85%)
    19 / 71 (26.76%)
         occurrences all number
    11
    21

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Feb 2020
    Changed from Phase 3 to Phase 2 Decreased the planned enrollment from 540 patients (Phase 3) to 128 patients (Phase 2) Changed PFS assessment by Blinded Independent Review Committee (Phase 3) to investigator assessed (Phase 2) Design was changed to provide 80% power for measuring PFS (Phase 2), instead of 90% power for measures of PFS and overall survival (Phase 3) Timing of final PFS analysis planned to occur when 85 PFS events had occurred (Phase 2), reduced from 363 PFS event (ie, 66% of the reduced target sample size) (Phase 3) Interim analysis was removed Provisions added to continue providing study drug to patients who received blinded pamiparib after unblinding Added provisions for emergency unblinding of a patient’s treatment assignment at the investigator’s discretion, per request by Regulatory Health Authority Reduced planned study duration from 3.5 years (Phase 3) to 2.5 years (Phase 2) Increased the safety precautions to reduce risk of pregnancies by requiring female partners of nonsterile male study patients to agree to practice highly effective methods of birth control and add limitation on sperm donation after last study drug administration.

    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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