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    Clinical Trial Results:
    A Single-Arm, Open-Label, Multicenter, Extended Treatment, Safety Study in Patients Treated With Talazoparib

    Summary
    EudraCT number
    		 2016-001972-31
    Trial protocol
    		 GB   HU   PL   DE  
    Global end of trial date
    20 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jun 2022
    First version publication date
    23 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MDV3800-13 (C3441010)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02921919
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    07 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to obtain additional safety data on long-term talazoparib use.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 10
    Country: Number of subjects enrolled
    Moldova, Republic of: 1
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 62
    Worldwide total number of subjects
    118
    EEA total number of subjects
    17
    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)
    68
    From 65 to 84 years
    47
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible subjects who received talazoparib as a single agent or in combination with another agent in following qualifying studies: PRP-001(NCT01286987), MDV3800-01(NCT02997163), MDV3800-02(NCT02997176), MDV3800-03(NCT03070548), MDV3800-04(NCT03077607), MDV3800-14(NCT03042910) continued talazoparib therapy as single agent in this extension study.

    Pre-assignment
    Screening details
    		 A total of 120 subjects were enrolled in the study of which 118 subjects received the study treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Initial Dose Talazoparib: < 1 mg/day
    Arm description
    		 Subjects were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of less than (<) 1 milligram (mg) orally once daily. Subjects received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Subjects were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Talazoparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily.

    Arm title
    		 Initial Dose Talazoparib: 1 mg/day
    Arm description
    		 Subjects were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of 1 mg orally once daily. Subjects received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Subjects were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Talazoparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of 1 mg orally once daily.

    Number of subjects in period 1
    		Initial Dose Talazoparib: < 1 mg/day Initial Dose Talazoparib: 1 mg/day
    Started
    66
    52
    Completed
    0
    0
    Not completed
    66
    52
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    5
    1
         Physician decision
    3
    2
         Adverse event, non-fatal
    6
    3
         Unspecified
    5
    6
         Lost to follow-up
    -
    1
         Disease Progression
    47
    38

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Initial Dose Talazoparib: < 1 mg/day
    Reporting group description
    		 Subjects were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of less than (<) 1 milligram (mg) orally once daily. Subjects received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Subjects were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

    Reporting group title
    Initial Dose Talazoparib: 1 mg/day
    Reporting group description
    		 Subjects were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of 1 mg orally once daily. Subjects received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Subjects were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

    Reporting group values
    		 Initial Dose Talazoparib: < 1 mg/day Initial Dose Talazoparib: 1 mg/day Total
    Number of subjects
    		 66 52 118
    Age Categorical
    Units: Subjects
        < 50 years
    		 10 9 19
        50 to <65 years
    		 30 17 47
        >= 65 years
    		 25 25 50
        Missing
    		 1 1 2
    Sex: Female, Male
    Units: Subjects
        Female
    		 46 37 83
        Male
    		 20 15 35
    Race
    Units: Subjects
        Asian
    		 3 0 3
        Black or African American
    		 1 2 3
        White
    		 59 48 107
        Unknown or Not Reported
    		 3 2 5
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 6 5 11
        Not Hispanic or Latino
    		 56 45 101
        Unknown or Not Reported
    		 4 2 6

    End points

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    End points reporting groups
    Reporting group title
    Initial Dose Talazoparib: < 1 mg/day
    Reporting group description
    		 Subjects were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of less than (<) 1 milligram (mg) orally once daily. Subjects received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Subjects were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

    Reporting group title
    Initial Dose Talazoparib: 1 mg/day
    Reporting group description
    		 Subjects were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of 1 mg orally once daily. Subjects received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Subjects were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

    Primary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs [1]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subject administered a study drug without regard to possibility of a causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death; inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or was considered as an important medical event. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. AE included both SAEs and all non-SAEs. Treatment-related TEAEs were defined as any TEAE with at least a possible relationship to the study drug as assessed by the investigator or that was missing the assessment of causal relationship whose relationship to the study drug could not be ruled out. Safety population included all subjects who received any amount of talazoparib.
    End point type
    Primary
    End point timeframe
    From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Initial Dose Talazoparib: < 1 mg/day Initial Dose Talazoparib: 1 mg/day
    Number of subjects analysed
    66
    52
    Units: Subjects
        TEAE
    63
    47
        SAE
    27
    18
        Treatment-related TEAEs
    45
    31
        Treatment-related SAEs
    6
    3
    No statistical analyses for this end point

    Primary: Number of Subjects With Grade 3 or 4 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4

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    End point title
    		 Number of Subjects With Grade 3 or 4 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4 [2]
    End point description
    An AE was any untoward medical occurrence in a subject administered a study drug without regard to possibility of a causal relationship. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. Severity was graded using NCI-CTCAE version 4 where, Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE. Number of subjects with Grade 3 or 4 TEAEs were reported. Safety population included all subjects who received any amount of talazoparib.
    End point type
    Primary
    End point timeframe
    From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Initial Dose Talazoparib: < 1 mg/day Initial Dose Talazoparib: 1 mg/day
    Number of subjects analysed
    66
    52
    Units: Subjects
    38
    32
    No statistical analyses for this end point

    Primary: Number of Subjects With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death

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    End point title
    		 Number of Subjects With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death [3]
    End point description
    An AE was any untoward medical occurrence in a subject administered a study drug without regard to possibility of a causal relationship. TEAEs were AEs that occurred on or after the administration of first dose of study drug through approximately 30 days after the last dose. Number of subjects with TEAEs leading to dose reduction, permanent study drug discontinuation and death were reported. Safety population included all subjects who received any amount of talazoparib.
    End point type
    Primary
    End point timeframe
    From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Initial Dose Talazoparib: < 1 mg/day Initial Dose Talazoparib: 1 mg/day
    Number of subjects analysed
    66
    52
    Units: Subjects
        TEAE leading to dose reduction
    6
    7
        TEAE leading to study drug discontinuation
    5
    4
        TEAE leading to death
    7
    7
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Laboratory Abnormalities: Liver Function Tests

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    End point title
    		 Number of Subjects With Clinically Significant Laboratory Abnormalities: Liver Function Tests [4]
    End point description
    The following liver parameters were analysed: aspartate transaminase (AST), alanine aminotransferase (ALT), total bilirubin (TBL) and alkaline phosphatase (ALP). The criteria for clinically significant abnormalities for liver parameters included AST or ALT greater than or equal to (>=) 3 times upper limit of normal (ULN); ALT or AST greater than (>) 5 times ULN; ALT or AST > 10 times ULN; ALT or AST > 20 times ULN; total TBL >2 times ULN; ALT or AST >= 3 times ULN and TBL > 2 times ULN and ALT or AST >= 3 times ULN and TBL > 2 times ULN and ALP < 2 times ULN. Safety population included all subjects who received any amount of talazoparib. Here, “number of subjects analysed” signifies number of subjects who were evaluable for this end point.
    End point type
    Primary
    End point timeframe
    From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Initial Dose Talazoparib: < 1 mg/day Initial Dose Talazoparib: 1 mg/day
    Number of subjects analysed
    61
    50
    Units: Subjects
        ALT or AST >= 3*ULN
    5
    2
        ALT or AST > 5*ULN
    0
    0
        ALT or AST > 10*ULN
    0
    0
        ALT or AST > 20*ULN
    0
    0
        TBL > 2*ULN
    4
    0
        ALT or AST >= 3*ULN and TBL > 2*ULN
    2
    0
        ALT or AST >=3*ULN and TBL > 2*ULN and ALP <2*ULN
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters

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    End point title
    		 Number of Subjects With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters [5]
    End point description
    The following hematology parameters were analysed: hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. Laboratory toxicities were graded using NCI-CTCAE version 4 where, grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death) for each parameter. Number of subjects with Grade 3 and 4 toxicities were reported. Low indicates values lower than the normal range. Safety population included all subjects who received any amount of talazoparib.
    End point type
    Primary
    End point timeframe
    From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Initial Dose Talazoparib: < 1 mg/day Initial Dose Talazoparib: 1 mg/day
    Number of subjects analysed
    66
    52
    Units: Subjects
        Hemoglobin (low): Grade 3
    7
    16
        Hemoglobin (low): Grade 4
    0
    0
        Leukocytes (low): Grade 3
    5
    2
        Leukocytes (low): Grade 4
    0
    0
        Lymphocytes (low): Grade 3
    11
    8
        Lymphocytes (low): Grade 4
    1
    1
        Neutrophils (low): Grade 3
    9
    4
        Neutrophils (low): Grade 4
    1
    0
        Platelets (low): Grade 3
    4
    4
        Platelets (low): Grade 4
    1
    1
    No statistical analyses for this end point

    Primary: Number of Subjects With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters

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    End point title
    		 Number of Subjects With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters [6]
    End point description
    The following chemistry parameters were analysed: alkaline phosphatase, bilirubin and creatinine. Laboratory toxicities were graded using NCI-CTCAE version 4 where, grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (potentially life threatening) and grade 5 (death) for each parameter. Number of subjects with Grade 3 or 4 toxicities were reported. High indicates values higher than the normal range. Safety population included all subjects who received any amount of talazoparib.
    End point type
    Primary
    End point timeframe
    From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Initial Dose Talazoparib: < 1 mg/day Initial Dose Talazoparib: 1 mg/day
    Number of subjects analysed
    66
    52
    Units: Subjects
        Alkaline Phosphatase (high): Grade 3
    5
    1
        Alkaline Phosphatase (high): Grade 4
    1
    0
        Bilirubin (high): Grade 3
    3
    0
        Bilirubin (high): Grade 4
    1
    0
        Creatinine (high): Grade 3
    1
    0
        Creatinine (high): Grade 4
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Changes in Vital Signs and Weight

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    End point title
    		 Number of Subjects With Clinically Significant Changes in Vital Signs and Weight [7]
    End point description
    Criteria for clinically significant changes in vital signs included a) Systolic blood pressure (SBP): 1) absolute results >180 millimeter of mercury (mmHg) and increase from baseline (IFB) >=40 mmHg, 2) absolute results <90 mmHg and decrease from baseline (DFB) >30 mmHg; b) Diastolic blood pressure (DBP): 1) absolute results >110 mmHg and IFB >=30 mmHg , 2) absolute results <50 mmHg and DFB >20 mmHg , 3) IFB >=20 mmHg; c) Heart rate: 1) absolute results >120 beats per minute (bpm) and IFB >30 bpm, 2) absolute results <50 bpm and >20 bpm DFB; d) Temperature: <=34.5 or >=38 degree Celsius. Criteria for clinically significant changes in weight: >10 percent (%) DFB. Safety population included all subjects who received any amount of talazoparib.
    End point type
    Primary
    End point timeframe
    From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Initial Dose Talazoparib: < 1 mg/day Initial Dose Talazoparib: 1 mg/day
    Number of subjects analysed
    66
    52
    Units: Subjects
        SBP: absolute results >180 mmHg and IFB >=40 mmHg
    1
    0
        SBP: absolute results <90 mmHg and DFB >30 mmHg
    1
    0
        DBP: absolute results >110 mmHg and IFB >=30 mmHg
    0
    0
        DBP: absolute results <50 mmHg and DFB >20 mmHg
    0
    0
        DBP: IFB >=20 mmHg
    6
    5
        Heart rate: absolute results>120 bpm & IFB>30 bpm
    2
    0
        Heart rate: absolute results<50 bpm & DFB>20 bpm
    0
    0
        Temperature: <=34.5 or >=38 degree Celsius
    0
    0
        Weight: >10% DFB
    7
    2
    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 up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
    Adverse event reporting additional description
    An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 subject and non-serious for another subject, or a subject may have experienced both a serious and non-serious episode of the same event. Safety population included all subjects who received any amount of talazoparib.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Initial Dose Talazoparib: 1 mg/day
    Reporting group description
    		 Subjects were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of 1 mg orally once daily. Subjects received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Subjects were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

    Reporting group title
    Initial Dose Talazoparib: < 1 mg/day
    Reporting group description
    		 Subjects were administered talazoparib capsules at an initial dose (i.e. the last tolerated dose in the originating study) of < 1 mg orally once daily. Subjects received talazoparib till the investigator considered treatment to be providing clinical benefit or until other study discontinuation criteria were met. Subjects were followed-up for safety until 30 days after the last dose of talazoparib (i.e., permanent discontinuation) or before initiation of a new antineoplastic therapy, whichever occurred first.

    Serious adverse events
    		 Initial Dose Talazoparib: 1 mg/day Initial Dose Talazoparib: < 1 mg/day
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 52 (34.62%)
    27 / 66 (40.91%)
         number of deaths (all causes)
    8
    7
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Intraductal Proliferative Breast Lesion
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Leukaemia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Pleural Effusion
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cancer
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Pericardial Effusion Malignant
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease Progression
         subjects affected / exposed
    0 / 52 (0.00%)
    4 / 66 (6.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Death
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gait Disturbance
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 66 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Platelet Count Decreased
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cauda Equina Syndrome
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         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
    Thrombocytopenia
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 66 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 66 (3.03%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 66 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Obstruction
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular Weakness
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain In Extremity
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Endocarditis Bacterial
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 66 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Abscess
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 66 (3.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal Sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure To Thrive
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gout
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Initial Dose Talazoparib: 1 mg/day Initial Dose Talazoparib: < 1 mg/day
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 52 (88.46%)
    54 / 66 (81.82%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant Ascites
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 66 (0.00%)
         occurrences all number
    5
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 52 (3.85%)
    4 / 66 (6.06%)
         occurrences all number
    2
    5
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 52 (11.54%)
    6 / 66 (9.09%)
         occurrences all number
    7
    8
    Fatigue
         subjects affected / exposed
    11 / 52 (21.15%)
    17 / 66 (25.76%)
         occurrences all number
    15
    20
    Oedema Peripheral
         subjects affected / exposed
    4 / 52 (7.69%)
    7 / 66 (10.61%)
         occurrences all number
    4
    7
    Pain
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 66 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 52 (7.69%)
    7 / 66 (10.61%)
         occurrences all number
    5
    8
    Dyspnoea
         subjects affected / exposed
    6 / 52 (11.54%)
    8 / 66 (12.12%)
         occurrences all number
    7
    8
    Investigations
    Blood Creatinine Increased
         subjects affected / exposed
    3 / 52 (5.77%)
    3 / 66 (4.55%)
         occurrences all number
    4
    6
    Neutrophil Count Decreased
         subjects affected / exposed
    4 / 52 (7.69%)
    4 / 66 (6.06%)
         occurrences all number
    7
    7
    Platelet Count Decreased
         subjects affected / exposed
    9 / 52 (17.31%)
    2 / 66 (3.03%)
         occurrences all number
    27
    12
    Weight Decreased
         subjects affected / exposed
    3 / 52 (5.77%)
    3 / 66 (4.55%)
         occurrences all number
    3
    3
    White Blood Cell Count Decreased
         subjects affected / exposed
    3 / 52 (5.77%)
    6 / 66 (9.09%)
         occurrences all number
    9
    19
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 52 (1.92%)
    6 / 66 (9.09%)
         occurrences all number
    1
    7
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 52 (0.00%)
    5 / 66 (7.58%)
         occurrences all number
    0
    6
    Headache
         subjects affected / exposed
    0 / 52 (0.00%)
    7 / 66 (10.61%)
         occurrences all number
    0
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    18 / 52 (34.62%)
    19 / 66 (28.79%)
         occurrences all number
    64
    41
    Iron Deficiency Anaemia
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 66 (0.00%)
         occurrences all number
    4
    0
    Neutropenia
         subjects affected / exposed
    4 / 52 (7.69%)
    10 / 66 (15.15%)
         occurrences all number
    8
    19
    Thrombocytopenia
         subjects affected / exposed
    5 / 52 (9.62%)
    10 / 66 (15.15%)
         occurrences all number
    13
    15
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    1 / 52 (1.92%)
    4 / 66 (6.06%)
         occurrences all number
    1
    5
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 52 (3.85%)
    5 / 66 (7.58%)
         occurrences all number
    2
    8
    Abdominal Pain
         subjects affected / exposed
    5 / 52 (9.62%)
    9 / 66 (13.64%)
         occurrences all number
    6
    12
    Constipation
         subjects affected / exposed
    2 / 52 (3.85%)
    8 / 66 (12.12%)
         occurrences all number
    2
    8
    Diarrhoea
         subjects affected / exposed
    3 / 52 (5.77%)
    8 / 66 (12.12%)
         occurrences all number
    3
    8
    Nausea
         subjects affected / exposed
    10 / 52 (19.23%)
    18 / 66 (27.27%)
         occurrences all number
    11
    21
    Vomiting
         subjects affected / exposed
    4 / 52 (7.69%)
    12 / 66 (18.18%)
         occurrences all number
    5
    17
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 52 (9.62%)
    6 / 66 (9.09%)
         occurrences all number
    5
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 52 (7.69%)
    6 / 66 (9.09%)
         occurrences all number
    5
    7
    Back Pain
         subjects affected / exposed
    2 / 52 (3.85%)
    10 / 66 (15.15%)
         occurrences all number
    2
    11
    Myalgia
         subjects affected / exposed
    1 / 52 (1.92%)
    4 / 66 (6.06%)
         occurrences all number
    1
    5
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    2 / 52 (3.85%)
    6 / 66 (9.09%)
         occurrences all number
    2
    9
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 52 (5.77%)
    8 / 66 (12.12%)
         occurrences all number
    3
    9
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    7 / 52 (13.46%)
    7 / 66 (10.61%)
         occurrences all number
    9
    10
    Hypokalaemia
         subjects affected / exposed
    1 / 52 (1.92%)
    5 / 66 (7.58%)
         occurrences all number
    1
    5
    Hypomagnesaemia
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 66 (1.52%)
         occurrences all number
    4
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Nov 2018
    The exclusion criteria of the study was updated to ensure the values of hemoglobin and platelet count were in line with the inclusion criteria of the originating Study MDV3800-02/C3441002 from version 4.0 onward for subjects with moderate/severe hepatic impairment to allow extended treatment with talazoparib after completion of the originating study. Talazoparib Dose Modifications guidelines had also been updated to reflect the changes of the exclusion criteria.

    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.
    In age group breakdown, data included 2 untreated subjects and excluded 2 subjects with missing data as presented in the age categorical field of baseline section. This is done due to database limitation as there is no option to report missing data.
    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.

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