Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 2, Open-Label, Single-Arm Study of Pamiparib (BGB-290) for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Homologous Recombination Deficiency (HRD)

    Summary
    EudraCT number
    		 2018-002587-28
    Trial protocol
    		 GB   ES  
    Global end of trial date
    02 Sep 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Dec 2021
    First version publication date
    18 Aug 2021
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Initially since this study was a terminated study and sample availability was low, data were not analyzed.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BGB-290-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03712930
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BeiGene, Ltd
    Sponsor organisation address
    BeiGene, Ltd., c/o BeiGene USA, Inc. 2955 Campus Drive, Suite 200 San Mateo, California , United States, 94403
    Public contact
    BeiGene DDT Call Center, BeiGene, 1 877-828-5568, clinicaltrials@beigene.com
    Scientific contact
    clinicaltrials@beigene.com, BeiGene, 1 877-828-5568, 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
    11 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Sep 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of pamiparib in patients with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD-positive; per Epic Sciences assay), as per Prostate Cancer Clinical Trials Working Group [PCWG3] criteria.
    Protection of trial subjects
    This trial was designed and monitored in accordance with Sponsor procedures, which comply with the ethical principles of GCP as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki. The IEC/IRB-approved ICF was signed and dated by the subject or the subject’s legally authorized representative before his or her participation in the study. A copy of each signed ICF was provided to the subject or the subject’s legally authorized representative. All signed and dated ICFs were retained in each patient’s study file or in the site file. For any updated or revised ICFs, written informed consent was obtained using the IEC/IRB-approved updated/revised ICFs for continued participation in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Feb 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    United States: 6
    Country: Number of subjects enrolled
    Spain: 1
    Worldwide total number of subjects
    13
    EEA total number of subjects
    1
    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)
    4
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Eighteen subjects were screened; 5 subjects failed screening and 13 subjects were dosed.

    Pre-assignment
    Screening details
    		 All subjects enrolled had unknown BRCA1/2 status at study entry and were assigned to cohorts 1B or 2B; there were no subjects known to be BRCA1/2 positive at enrollment.

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

    Arms
    Arm title
    		 Pamiparib
    Arm description
    		 Participants received 60 mg pamiparib orally twice daily
    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 mg pamiparib capsule orally twice daily

    Number of subjects in period 1
    		Pamiparib
    Started
    13
    Completed
    0
    Not completed
    13
         Physician decision
    1
         Death
    7
         Progressive Disease
    2
         Study terminated by sponsor
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 -

    Reporting group values
    		 Overall Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 4 4
        From 65 to 84 years
    		 9 9
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.3 ( 9.49 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 13 13

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Pamiparib
    Reporting group description
    		 Participants received 60 mg pamiparib orally twice daily

    Primary: Objective Response Rate (ORR) Determined by Independent Central Review

    		 Close Top of page
    End point title
    		 Objective Response Rate (ORR) Determined by Independent Central Review [1]
    End point description
    ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by an Independent Review Committee (IRC). Efficacy-Evaluable Analysis Set: includes all participants in the Safety Analysis Set who had measurable disease at baseline and at least 1 post-baseline tumor assessment, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before tumor assessment. Participants with available data were included in the analysis.
    End point type
    Primary
    End point timeframe
    Up to 1 year and 6 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: This study stopped prematurely and only 13 subjects enrolled. No summary statistics are available given the limited data from the small number of evaluable subjects.
    End point values
    		 Pamiparib
    Number of subjects analysed
    12
    Units: Percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Primary: Prostate-Specific Antigen (PSA) Response Rate

    		 Close Top of page
    End point title
    		 Prostate-Specific Antigen (PSA) Response Rate [2]
    End point description
    PSA response rate is defined as the percentage of participants with PSA decline ≥ 50% from baseline [confirmed by a second PSA value ≥ 3 weeks later] for CTC-HRD-positive patients with or without measurable disease. PSA-Evaluable Analysis Set: includes all participants in the Safety Analysis Set with ≥3 rising PSA levels with ≥ 1 week between determinations and screening PSA ≥ 2 μg/L) and who had at least 1 post-baseline PSA measurement unless they permanently discontinue pamiparib or the study early due to clinical progression or death before completed PSA assessment.
    End point type
    Primary
    End point timeframe
    Up to 1 year and 6 months
    Notes
    [2] - 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: This study stopped prematurely and only 13 subjects enrolled. No summary statistics are available given the limited data from the small number of evaluable subjects.
    End point values
    		 Pamiparib
    Number of subjects analysed
    13
    Units: Percentage of Participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Duration of Response

    		 Close Top of page
    End point title
    		 Duration of Response
    End point description
    DOR is defined as the time from the date of the earliest documented CR or PR (that is subsequently confirmed) to radiographic disease progression or death due to any cause, whichever occurs first. Efficacy-Evaluable Analysis Set: includes all participants in the Safety Analysis Set who had measurable disease at baseline and at least 1 post-baseline tumor assessment, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before tumor assessment. Participants with available data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 7 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    12 [3]
    Units: Months
    9999
    Notes
    [3] - 9999 = Not applicable; No confirmed CR/PR. Duration of Response is not applicable.
    No statistical analyses for this end point

    Secondary: Objective Response Rate by Investigator

    		 Close Top of page
    End point title
    		 Objective Response Rate by Investigator
    End point description
    ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by the investigator. Efficacy-Evaluable Analysis Set: includes all participants in the Safety Analysis Set who had measurable disease at baseline and at least 1 post-baseline tumor assessment, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before tumor assessment. Participants with available data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 6 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    12
    Units: Percentage of Participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Time to Objective Response by Investigator

    		 Close Top of page
    End point title
    		 Time to Objective Response by Investigator
    End point description
    Time to objective response is defined as the time from the date of the first dose of study drug to the first documented confirmed response of CR or PR assessed by the investigator and summarized for participants who have achieved a confirmed objective response. Efficacy-Evaluable Analysis Set: includes all participants in the Safety Analysis Set who had measurable disease at baseline and at least 1 post-baseline tumor assessment, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before tumor assessment. Participants with available data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 6 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    12 [4]
    Units: Months
    9999
    Notes
    [4] - 9999 = Not applicable; No participants with confirmed CR/PR. Time to response is not applicable.
    No statistical analyses for this end point

    Secondary: Clinical Benefit Rate By Investigator

    		 Close Top of page
    End point title
    		 Clinical Benefit Rate By Investigator
    End point description
    Clinical benefit rate is defined as the percentage of participants with a documented confirmed CR, PR, or stable disease
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 6 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    12
    Units: Percentage of participants
        number (not applicable)
    25
    No statistical analyses for this end point

    Secondary: Time to PSA Response

    		 Close Top of page
    End point title
    		 Time to PSA Response
    End point description
    Time to PSA response is defined as the time from the date of the first dose of study drug to the first PSA decline ≥ 50% that is subsequently confirmed. Assessments are summarized for participants who have achieved a confirmed PSA response. PSA-Evaluable Analysis Set: includes all participants in the Safety Analysis Set with ≥3 rising PSA levels with ≥ 1 week between determinations and screening PSA ≥ 2 μg/L and who had at least 1 post-baseline PSA measurement, unless they permanently discontinue pamiparib or the study early due to clinical progression or death before completed PSA assessment.
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 6 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    13 [5]
    Units: Months
    9999
    Notes
    [5] - 9999 = Not applicable; Participants with PSA response is 0. Time to PSA response is not applicable
    No statistical analyses for this end point

    Secondary: Duration of PSA Response

    		 Close Top of page
    End point title
    		 Duration of PSA Response
    End point description
    Duration of PSA response is defined as the time from the date of the earliest documented PSA response (that is subsequently confirmed) to PSA progression or death due to any cause, whichever occurs first. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 μg/L above the nadir (or above the baseline for patients with no PSA decline after12 weeks), confirmed by a second value ≥ 3 weeks later. The nadir is defined as the lowest value at or after baseline. PSA-Evaluable Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 7 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    13 [6]
    Units: Months
    9999
    Notes
    [6] - 9999 = Not applicable; Participants with PSA Response is 0. Duration of PSA response not applicable
    No statistical analyses for this end point

    Secondary: Time to PSA Progression

    		 Close Top of page
    End point title
    		 Time to PSA Progression
    End point description
    Time to PSA progression is defined as the time from the date of the first dose of study drug to a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir [or above the baseline for participants with no PSA decline after 12 weeks], confirmed by a second value ≥ 3 weeks later. Safety Analysis Set : includes all participants enrolled into the study who received any dose of pamiparib.
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 7 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    13
    Units: Months
        arithmetic mean (standard deviation)
    3.13 ( 1.533 )
    No statistical analyses for this end point

    Secondary: Time to Symptomatic Skeletal Event

    		 Close Top of page
    End point title
    		 Time to Symptomatic Skeletal Event
    End point description
    Time to symptomatic skeletal event is defined as time from the date of the first dose of study drug to the first symptomatic fracture, radiation or surgery to bone, or spinal cord compression
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 7 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    13 [7]
    Units: Months
    9999
    Notes
    [7] - 9999 = Not applicable; Not participants had SSE
    No statistical analyses for this end point

    Secondary: Radiographic Progression-Free Survival

    		 Close Top of page
    End point title
    		 Radiographic Progression-Free Survival
    End point description
    Radiographic progression-free survival is defined as the time from the date of the first dose of study drug to radiographic disease progression by IRC or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 7 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    13
    Units: Months
        median (confidence interval 95%)
    2.6 (1.5 to 3.7)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

    		 Close Top of page
    End point title
    		 Overall survival (OS)
    End point description
    Overall survival is defined as the time from the date of the first dose of study drug to death due to any cause. Safety Analysis Set: includes all participants enrolled in the study who received any dose of pamiparib.
    End point type
    Secondary
    End point timeframe
    Up to 1 year and 7 months
    End point values
    		 Pamiparib
    Number of subjects analysed
    13
    Units: Months
        median (confidence interval 95%)
    5.8 (1.6 to 5.9)
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-Emergent Adverse Events graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)Version 4.03

    		 Close Top of page
    End point title
    		 Number of Participants with Treatment-Emergent Adverse Events graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)Version 4.03
    End point description
    End point type
    Secondary
    End point timeframe
    From the date of first Pamiparib dose until 30 days after the last dose or initiation of new anti-cancer therapy, whichever occurs first. (Up to 1 year and 7 months)
    End point values
    		 Pamiparib
    Number of subjects analysed
    13
    Units: Number
        Participants with at Least One TEAE
    13
        Grade 3 or Higher
    11
        Serious
    6
        Leading to Death
    1
        Leading to Treatment Discontinuation
    3
        Leading to Dose Modification
    11
        Leading to Dose Interruption
    9
        Leading to Dose Reduction
    5
        Treatment Related TEAEs
    11
        Treatment Related Grade 3 or Higher
    7
        Treatment Related Serious
    1
        Treatment Related Leading to Death
    0
        Treatment Related Leading to Discontinuation
    3
        Treatment Related Leading to Dose Modification
    7
        Treatment Related Leading to Dose Interruption
    6
        Treatment Related Leading to Dose Reduction
    3
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From the date of first dose of Pamiparib until 30 days after the last dose or initiation of new anti-cancer therapy, whichever occurs first (up to approximately 1 year and 7 months)
    Adverse event reporting additional description
    Safety Analysis Set (SAF): included all subjects enrolled in the study who received any dose of pamiparib. The Safety Analysis Set was used for all safety analyses.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Pamiparib
    Reporting group description
    		 Participants received 60 mg pamiparib orally twice daily

    Serious adverse events
    		 Pamiparib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 13 (46.15%)
         number of deaths (all causes)
    9
         number of deaths resulting from adverse events
    1
    Nervous system disorders
    Hemiparesis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Pamiparib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 13 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 13 (38.46%)
         occurrences all number
    5
    Asthenia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    2
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Investigations
    Weight decreased
         subjects affected / exposed
    3 / 13 (23.08%)
         occurrences all number
    4
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    2
    Blood creatinine increased
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Taste disorder
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 13 (53.85%)
         occurrences all number
    11
    Neutropenia
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    4
    Thrombocytopenia
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    2
    Leukopenia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Orbital oedema
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 13 (53.85%)
         occurrences all number
    8
    Diarrhoea
         subjects affected / exposed
    4 / 13 (30.77%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    4 / 13 (30.77%)
         occurrences all number
    4
    Abdominal pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Rectal tenesmus
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    2
    Back pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    2
    Oral candidiasis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 13 (46.15%)
         occurrences all number
    6
    Dehydration
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    2
    Hypophosphataemia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Malnutrition
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Oct 2018
    To incorporate additional changes based on feedback from the United States Food and Drug Administration (US FDA) To incorporate changes per BeiGene protocol template for better consistency across multiple studies Minor editorial and formatting changes have been made to enhance clarity and readability;

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 May 2020
    Due to changes in standard of care for mCRPC, slow enrollment and lack of responses in this heavily pretreated patient population, the study was terminated.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon Apr 29 10:22:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA