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   43974   clinical trials with a EudraCT protocol, of which   7312   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:
    Talapro-1: A Phase 2, Open-Label, Response Rate Study of Talazoparib in Men with DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide And/or Abiraterone Acetate/Prednisone)

    Summary
    EudraCT number
    2016-002036-32
    Trial protocol
    DE   NL   ES   FR   BE   GB   AT   DK   HU   IT  
    Global end of trial date
    31 Mar 2023

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

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    C3441006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03148795
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    MDV3800-06: Other ID
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer Inc., Pfizer ClinicalTrials.gov Call Center, 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
    04 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy, of single agent talazoparib in Deoxyribonucleic acid damage repair (DDR) + Metastatic castration-resistant prostate cancer (mCRPC) as measured by best objective response rate (ORR).
    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
    04 Jul 2017
    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
    Australia: 11
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Brazil: 1
    Country: Number of subjects enrolled
    French Guiana: 22
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Belgium: 12
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Netherlands: 15
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    127
    EEA total number of subjects
    69
    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)
    39
    From 65 to 84 years
    88
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects with measurable soft tissue disease as per RECIST 1.1 and progressive metastatic castration-resistant prostate cancer (CRPC) and DNA damage repair deficiencies, previously received 1 to 2 taxane-based chemotherapy and progressed on at least 1 line of novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) were enrolled.

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

    Arms
    Arm title
    Talazoparib
    Arm description
    Subjects received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the subject was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.
    Arm type
    Experimental

    Investigational medicinal product name
    Talazoparib
    Investigational medicinal product code
    Other name
    PF-06944076
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received talazoparib 1 milligram per day (mg/day).

    Number of subjects in period 1
    Talazoparib
    Started
    127
    Completed
    126
    Not completed
    1
         Progressive Disease
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Talazoparib
    Reporting group description
    Subjects received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the subject was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.

    Reporting group values
    Talazoparib Total
    Number of subjects
    127 127
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    39 39
        From 65-84 years
    88 88
        85 years and over
    0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    68.16 ± 8.02 -
    Sex: Female, Male
    Units: Subjects
        Female
    0 0
        Male
    127 127
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    4 4
        Not Hispanic or Latino
    106 106
        Unknown or Not Reported
    17 17
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0
        Asian
    3 3
        Native Hawaiian or Other Pacific Islander
    0 0
        Black or African American
    4 4
        White
    110 110
        More than one race
    0 0
        Unknown or Not Reported
    10 10

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Talazoparib
    Reporting group description
    Subjects received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the subject was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.

    Primary: Best Objective Response Rate (ORR)

    Close Top of page
    End point title
    Best Objective Response Rate (ORR) [1]
    End point description
    Best ORR was defined as the percentage of subjects with best overall soft tissue response of complete response (CR) or partial response (PR) as per RECIST1.1 by an independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline sum diameters. DDR deficient measurable disease population included all enrolled subjects who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib.
    End point type
    Primary
    End point timeframe
    From first dose of study drug to best overall soft tissue response CR or PR (maximum duration of 25 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No 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.
    End point values
    Talazoparib
    Number of subjects analysed
    104
    Units: Percentage of subjects
        number (confidence interval 95%)
    29.8 (21.2 to 39.6)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

    Close Top of page
    End point title
    Duration of Response (DOR)
    End point description
    DOR was defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) per RECIST 1.1 and no evidence of confirmed bone disease progression per PCWG3 to the date of first objective evidence of radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters. DDR deficient measurable disease population evaluated. 99999 indicates Upper limit of 95% confidence interval (CI) was not estimable as there were less number of subjects with an event.
    End point type
    Secondary
    End point timeframe
    From the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first (maximum duration of 25 months)
    End point values
    Talazoparib
    Number of subjects analysed
    31
    Units: Months
        median (confidence interval 95%)
    12.8 (6.5 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Prostate-Specific Antigen (PSA) Response of Greater Than or Equal to (>=) 50 Percentage (%)

    Close Top of page
    End point title
    Percentage of Subjects With Prostate-Specific Antigen (PSA) Response of Greater Than or Equal to (>=) 50 Percentage (%)
    End point description
    Percentage of subjects with PSA response of >= 50% was reported in this outcome measure. PSA response was calculated as a decline from baseline PSA (ng/mL) by at least 50% measured by central laboratory. Final analyses for this endpoint was till the cutoff date 04 September 2020. DDR deficient measurable disease population included all enrolled subjects who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib. Here ‘’Number of subjects analyzed’’ signifies number of subjects evaluable data for this endpoint.
    End point type
    Secondary
    End point timeframe
    From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)
    End point values
    Talazoparib
    Number of subjects analysed
    96
    Units: Percentage of subjects
        number (confidence interval 95%)
    45.8 (35.6 to 56.3)
    No statistical analyses for this end point

    Secondary: Time to Objective Response

    Close Top of page
    End point title
    Time to Objective Response
    End point description
    Time to objective response was defined as the time from first dose of talazoparib to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per prostate cancer working Group 3 (PCWG3). Soft tissue response is defined as a best overall response of CR or PR per RECIST 1.1 by independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 % decrease in sum of diameters of target lesions taking as reference baseline sum diameters. DDR deficient measurable disease population evaluated.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug to first objective response (maximum duration of 25 months)
    End point values
    Talazoparib
    Number of subjects analysed
    31
    Units: Months
        median (full range (min-max))
    3.4 (1.6 to 7.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Conversion of Circulating Tumor Cell (CTC) Count

    Close Top of page
    End point title
    Percentage of Subjects With Conversion of Circulating Tumor Cell (CTC) Count
    End point description
    Percentage of subjects with conversion of CTC count was defined as percentage of subjects with a CTC count >= 5 CTC per 7.5 milliliter (mL) of blood at baseline that decreased to < 5 CTC per 7.5 mL of blood any time on study. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects with a baseline CTC assessment and at least 1 post-baseline CTC assessment from the DDR deficient measurable disease population. Subjects with a CTC count <5 per 7.5 mL of blood at baseline were not analyzed for this conversion endpoint. Here, "Number of subjects analyzed’’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to anytime on study during final analyses (maximum duration of 25 months)
    End point values
    Talazoparib
    Number of subjects analysed
    33
    Units: Percentage of subjects
        number (confidence interval 95%)
    63.6 (45.1 to 79.6)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With a Null CTC Count

    Close Top of page
    End point title
    Percentage of Subjects With a Null CTC Count
    End point description
    Percentage of subjects with a null CTC count was defined as percentage of subjects with CTC count >=1 CTC per 7.5 mL of blood at baseline that decreased to CTC = 0 per 7.5 mL of blood any time on study. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects with a baseline CTC assessment and at least 1 post-baseline CTC assessment from the DDR deficient measurable disease population. Subjects with a CTC count 0 per 7.5 mL of blood at baseline were not analyzed for this endpoint. Here, "Number of subjects analyzed’’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to anytime on study during final analyses (maximum duration of 25 months)
    End point values
    Talazoparib
    Number of subjects analysed
    45
    Units: Percentage of subjects
        number (confidence interval 95%)
    53.3 (37.9 to 68.3)
    No statistical analyses for this end point

    Secondary: : Percentage of Subjects With Baseline CTC Count <5 CTC Showed Increased CTC Counts at any Time on Study

    Close Top of page
    End point title
    : Percentage of Subjects With Baseline CTC Count <5 CTC Showed Increased CTC Counts at any Time on Study
    End point description
    Percentage of subjects with CTC count <5 CTC per 7.5 mL of blood at baseline those who showed an increased CTC count, compared to baseline, any time on study was reported in this study. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects with a baseline CTC assessment and at least 1 post-baseline CTC assessment from the DDR deficient measurable disease population. Here, "Number of subjects analyzed’’ signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to anytime on study during final analyses (maximum duration of 25 months)
    End point values
    Talazoparib
    Number of subjects analysed
    29
    Units: Percentage of subjects
        number (confidence interval 95%)
    37.9 (20.7 to 57.7)
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Time to Prostate-Specific Antigen (PSA) Progression
    End point description
    Time to PSA progression was defined as the time from first dose of study treatment to the date of PSA progression, which was subsequently confirmed. The time from first dose of talazoparib to the date that a >=25% increase in PSA with an absolute increase of ≥2micogram per liter (2 nanogram per mL) above the nadir (or baseline for subjects with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained >=3 weeks (21 days) later. Kaplan-Meier method was used for analysis. Final analyses for this endpoint was till the cutoff date 04 September 2020. DDR deficient measurable disease population included all enrolled subjects who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib.
    End point type
    Secondary
    End point timeframe
    From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)
    End point values
    Talazoparib
    Number of subjects analysed
    104
    Units: Months
        median (confidence interval 95%)
    9.2 (5.6 to 11.1)
    No statistical analyses for this end point

    Secondary: Radiographic Progression-Free Survival (PFS)

    Close Top of page
    End point title
    Radiographic Progression-Free Survival (PFS)
    End point description
    Radiographic PFS was defined as the time from date of first dose of talazoparib to first objective evidence of radiographic progression as assessed in soft tissue per modified RECIST 1.1 or confirmed progression in bone per PCWG3 guidelines by independent central review or death without documented radiographic progression, whichever occurs first. DDR deficient measurable disease population included all enrolled subjects who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib.
    End point type
    Secondary
    End point timeframe
    From date of first dose of study drug to first objective evidence of radiographic progression or death without documented radiographic progression, whichever occurs first (maximum duration of 25 months)
    End point values
    Talazoparib
    Number of subjects analysed
    104
    Units: Months
        median (confidence interval 95%)
    5.6 (3.7 to 8.8)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    Close Top of page
    End point title
    Overall Survival (OS)
    End point description
    OS was defined as the time from start date (the date of first dose of treatment) to the date of death due to any cause. Subjects who had not died were censored at the date of last contact. Kaplan-Meier method was used for analysis. Final analyses for this endpoint was till the cutoff date 31 March 2023. DDR deficient measurable disease population included all enrolled subjects who had measurable soft tissue disease at screening by investigator assessment, had DDR deficiencies likely to sensitize to PARP inhibitor therapy, and received at least 1 dose of talazoparib.
    End point type
    Secondary
    End point timeframe
    From first dose of study treatment up to death due to any cause during study or date of last contact (approximately 36 months)
    End point values
    Talazoparib
    Number of subjects analysed
    104
    Units: Months
        median (confidence interval 95%)
    16.9 (13.0 to 20.7)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Permanent Treatment Discontinuation Due to Adverse Events

    Close Top of page
    End point title
    Number of Subjects With Permanent Treatment Discontinuation Due to Adverse Events
    End point description
    Treatment discontinuation was defined as permanent cessation of study drug treatment administration. Safety population included all subjects who received at least 1 dose of talazoparib including subjects enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel.
    End point type
    Secondary
    End point timeframe
    During study treatment (approximately up to 36 months)
    End point values
    Talazoparib
    Number of subjects analysed
    127
    Units: Subjects
    21
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

    Close Top of page
    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subjects who received study drug without regard to possibility of causal relationship. AEs included both serious AEs and all non-serious AEs. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety population included all subjects who received at least 1 dose of talazoparib including subjects enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel.
    End point type
    Secondary
    End point timeframe
    First dose of study drug up to 28 days after last dose of study drug (study treatment was approximately for 36 months, safety follow up to approximately 37 months)
    End point values
    Talazoparib
    Number of subjects analysed
    127
    Units: Subjects
    125
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Abnormalities in Vital Signs

    Close Top of page
    End point title
    Number of Subjects With Clinically Significant Abnormalities in Vital Signs
    End point description
    Vital sign abnormalities criteria included: 1) Systolic blood pressure (SBP) in millimeters of mercury (mmHg): absolute result (AR) greater than (>) 180 mmHg and increase from baseline (IFB) greater than or equal to (>=) 40 mmHg or AR < 90 mmHg and decrease from baseline (DFB) > 30 mmHg; 2) Diastolic blood pressure (DBP) (mmHg): AR > 110 mmHg and IFB >= 30 mmHg or AR < 50 mmHg and DFB > 20 mmHg or >= 20 mmHg IFB; 3) Heart rate in beats per minutes (bpm): AR < 50 bpm and DFB > 20 bpm or AR > 120 bpm and IFB > 30 bpm; Weight in kilogram: > 10% DFB. Safety population evaluated. Here, “Number of Subjects Analyzed” signifies subjects evaluable for this endpoint and "n” signifies those subjects who were evaluable at specified rows.
    End point type
    Secondary
    End point timeframe
    During study treatment (approximately up to 36 months)
    End point values
    Talazoparib
    Number of subjects analysed
    125
    Units: Subjects
        SBP: AR >180 mmHg & IFB >=40 mmHg,n=125
    0
        SBP: AR <90 mmHg & DFB >30 mmHg, n=125
    0
        DBP: AR >110mmHg & IFB >=30mmHg, n=125
    0
        DBP: AR <50 mmHg & DFB >20 mmHg, n=125
    0
        DBP: >= 20 mmHg IFB, n=125
    17
        Heart rate: AR < 50bpm & DFB >20bpm, n=125
    0
        Heart rate: AR >120 bpm & IFB >30 bpm, n=125
    2
        Weight: > 10% DFB, n=124
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Shift in Laboratory Parameter Values (Hematology) From Grade less than equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline

    Close Top of page
    End point title
    Number of Subjects With Shift in Laboratory Parameter Values (Hematology) From Grade less than equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline
    End point description
    Hematology parameters included anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, Leukocytosis and white blood cell decreased. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Safety population evaluated. Here, “Number of Subjects Analyzed” signifies subjects evaluable for this endpoint. “n” signifies subjects evaluable at specific rows.
    End point type
    Secondary
    End point timeframe
    During study treatment (approximately up to 36 months)
    End point values
    Talazoparib
    Number of subjects analysed
    125
    Units: Subjects
        Anemia, n=125
    30
        Hemoglobin increased, n=125
    1
        Lymphocyte count decreased, n=125
    23
        Lymphocyte count increased, n=125
    0
        Neutrophil count decreased, n=125
    11
        Platelet count decreased, n=125
    3
        White blood cell decreased, n=125
    5
        Leukocytosis, n=125
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline

    Close Top of page
    End point title
    Number of Subjects With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline
    End point description
    Parameters: alanine aminotransferase (AT) increased (inc), alkaline phosphatase inc, aspartate AT inc, blood bilirubin inc, chronic kidney disease, creatinine inc, gamma-glutamyl transferase (GGT) inc, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypocalcemia, hyponatremia, hypoglycemia, hypokalemia, hypomagnesemia, hypernatremia, hypoalbuminemia, hypophosphatemia. Grade(G)1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G2:moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G3:severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; G4:life-threatening consequence, urgent intervention indicated; G5: death related to AEs. Safety set used. “Number of Subjects Analyzed”: subjects evaluable for endpoint; “n”: subjects evaluable at specific rows.
    End point type
    Secondary
    End point timeframe
    During study treatment (approximately up to 36 months)
    End point values
    Talazoparib
    Number of subjects analysed
    126
    Units: Subjects
        Alanine aminotransferase increased, n=126
    0
        Alkaline phosphatase increased, n=126
    9
        Aspartate aminotransferase increased, n=126
    0
        Blood bilirubin increased, n=126
    0
        Chronic kidney disease, n=126
    2
        Creatinine increased, n=126
    1
        GGT increased, n=53
    3
        Hypercalcemia, n=126
    0
        Hyperglycemia, n=126
    5
        Hyperkalemia, n=126
    4
        Hypermagnesemia, n=126
    1
        Hypernatremia, n=126
    0
        Hypoalbuminemia, n=126
    0
        Hypocalcemia, n=126
    4
        Hypoglycemia, n=126
    0
        Hypokalemia, n=126
    0
        Hypomagnesemia, n=126
    1
        Hyponatremia, n=126
    3
        Hypophosphatemia, n=126
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Dose Modification

    Close Top of page
    End point title
    Number of Subjects With Dose Modification
    End point description
    Number of subjects with dose modification due to adverse events was reported. Safety population included all subjects who received at least 1 dose of talazoparib including subjects enrolled prior to amendment 3 with non-measurable disease and/or with DDR deficiencies, which may sensitize the tumor to PARP inhibition as assessed using an expanded DDR gene panel.
    End point type
    Secondary
    End point timeframe
    During study treatment (approximately up to 36 months)
    End point values
    Talazoparib
    Number of subjects analysed
    127
    Units: Subjects
    37
    No statistical analyses for this end point

    Secondary: Time to Deterioration in Pain Symptom Scores

    Close Top of page
    End point title
    Time to Deterioration in Pain Symptom Scores
    End point description
    Time deterioration is based on BPI-SF question 3: “Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours.” Pain intensity was to be answered on a range of 0 to 10, where 0 corresponded to no pain and 10 worst pain. Time to this event is defined as the time from the date of first dose of study treatment to onset of pain progression, where pain progression is defined as a 2-point or more increase from baseline in the question 3 score. Kaplan-Meier method was used for analysis. Average of all assessments visits is reported in this endpoint. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline till final analysis (maximum duration of 25 months)
    End point values
    Talazoparib
    Number of subjects analysed
    97
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Subjects Reported Pain Scores per BPI-SF Question 3 Through Final Analysis

    Close Top of page
    End point title
    Change From Baseline in Subjects Reported Pain Scores per BPI-SF Question 3 Through Final Analysis
    End point description
    BPI-SF:11-item self-report questionnaire, assessed severity and impact of pain on daily functions. BPI-SF have 4 questions to assess pain intensity (worst, least, average, right now) and 7 questions to assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale from 0 (No pain) to 10 (Pain as bad as you can imagine). Measure can be scored by item, lower scores = less pain or pain interference. BPI-SF question 3 was related to subjects experiencing worst pain in last 24 hours, score range 0 to 10, large values = worse outcomes. Final analysis for this endpoint was till the cutoff date 04 September 2020. DDR deficient measurable disease population evaluated. All subjects reported under 'Number of Subjects Analyzed’ contributed data to the table; however, may not have evaluable data for every row. “n” signifies subjects evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 3, 5, 7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
    End point values
    Talazoparib
    Number of subjects analysed
    97
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 1, n=0
    99999 ± 99999
        Change at Week 3, n=70
    -0.51 ± 2.04
        Change at Week 5, n=72
    -1.39 ± 2.55
        Change at Week 7, n=61
    -1.20 ± 2.89
        Change at Week 9, n=63
    -1.25 ± 2.38
        Change at Week 13, n=55
    -0.85 ± 2.51
        Change at Week 17, n=54
    -1.06 ± 2.73
        Change at Week 21, n=44
    -0.89 ± 2.77
        Change at Week 25, n=44
    -1.14 ± 3.14
        Change at Week 37, n=27
    -1.00 ± 2.30
        Change at Week 49, n=17
    -1.53 ± 3.50
        Change at Week 61, n=12
    -2.50 ± 3.42
        Change at Week 73, n=5
    -2.80 ± 5.17
        Change at Week 85, n=2
    -5.50 ± 3.54
        Change at Follow-up, n=24
    -0.25 ± 3.21
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS)

    Close Top of page
    End point title
    Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS)
    End point description
    The EQ-5D VAS score was a subjects rated questionnaire where subjects rated how they felt at assessment visit on a vertical VAS that ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating a better health condition. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All subjects reported under ‘Number of Subjects Analyzed’ contributed data to the table; however, may not have evaluable data for every row. Here, “n” signifies number of subjects evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
    End point values
    Talazoparib
    Number of subjects analysed
    97
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Change at Week 1, n=0
    99999 ± 99999
        Change at Week 3, n=89
    4.16 ± 17.25
        Change at Week 5, n=93
    4.44 ± 17.26
        Change at Week 7, n=84
    6.61 ± 17.20
        Change at Week 9, n=88
    6.18 ± 20.21
        Change at Week 13, n=71
    7.68 ± 16.85
        Change at Week 17, n=73
    7.84 ± 19.40
        Change at Week 21, n=62
    6.63 ± 19.26
        Change at Week 25, n=59
    5.34 ± 21.50
        Change at Week 37, n=37
    4.65 ± 19.01
        Change at Week 49, n=23
    8.96 ± 17.55
        Change at Week 61, n=16
    12.75 ± 19.02
        Change at Week 73, n=8
    1.25 ± 24.89
        Change at Week 85, n=4
    11.50 ± 25.01
        Change at Week 97, n=1
    17.00 ± 99999
        Change at Follow-up, n=30
    -2.87 ± 21.55
    No statistical analyses for this end point

    Secondary: Number of Subjects With 5 Response Levels for EQ-5D-5L Mobility Domain

    Close Top of page
    End point title
    Number of Subjects With 5 Response Levels for EQ-5D-5L Mobility Domain
    End point description
    EQ-5D-5L: subjects rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D mobility domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All subjects reported under ‘Number of Subjects Analyzed’ contributed data to the table; however, may not have evaluable data for every row. Here, “n” signifies number of subjects evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
    End point values
    Talazoparib
    Number of subjects analysed
    97
    Units: Subjects
        Week 1, No Problem, n=96
    30
        Week 3, No Problem, n=90
    36
        Week 5, No Problem, n=95
    36
        Week 7, No Problem, n=86
    37
        Week 9, No Problem, n=90
    38
        Week 13, No Problem, n=73
    28
        Week 17, No Problem, n=74
    30
        Week 21, No Problem, n=63
    30
        Week 25, No Problem, n=59
    29
        Week 37, No Problem, n=37
    16
        Week 49, No Problem, n=23
    10
        Week 61, No Problem, n=16
    7
        Week 73, No Problem, n=8
    4
        Week 85, No Problem, n=4
    2
        Week 97, No Problem, n=1
    1
        Follow-up, No Problem, n=30
    11
        Week 1, Slight Problem, n=96
    29
        Week 3, Slight Problem, n=90
    23
        Week 5, Slight Problem, n=95
    29
        Week 7, Slight Problem, n=86
    24
        Week 9, Slight Problem, n=90
    26
        Week 13, Slight Problem, n=73
    26
        Week 17, Slight Problem, n=74
    28
        Week 21, Slight Problem, n=63
    15
        Week 25, Slight Problem, n=59
    14
        Week 37, Slight Problem, | n=37
    14
        Week 49, Slight Problem, | n=23
    7
        Week 61, Slight Problem, n=16
    5
        Week 73, Slight Problem, n=8
    2
        Week 85, Slight Problem, n=4
    2
        Week 97, Slight Problem, n=1
    0
        Follow-up, Slight Problem, n=30
    8
        Week 1, Moderate Problem, n=96
    25
        Week 3, Moderate Problem, n=90
    20
        Week 5, Moderate Problem, n=95
    23
        Week 7, Moderate Problem, n=86
    22
        Week 9, Moderate Problem, n=90
    20
        Week 13, Moderate Problem, n=73
    12
        Week 17, Moderate Problem, n=74
    14
        Week 21, Moderate Problem, n=63
    15
        Week 25, Moderate Problem, n=59
    13
        Week 37, Moderate Problem, n=37
    4
        Week 49, Moderate Problem, n=23
    5
        Week 61, Moderate Problem, n=16
    3
        Week 73, Moderate Problem, n=8
    2
        Week 85, Moderate Problem, n=4
    0
        Week 97, Moderate Problem, n=1
    0
        Follow-up, Moderate Problem, n=30
    6
        Week 1, Severe Problem, n=96
    12
        Week 3, Severe Problem, n=90
    10
        Week 5, Severe Problem, n=95
    6
        Week 7, Severe Problem, n=86
    3
        Week 9, Severe Problem, n=90
    4
        Week 13, Severe Problem, n=73
    5
        Week 17, Severe Problem, n=74
    1
        Week 21, Severe Problem, n=63
    3
        Week 25, Severe Problem, n=59
    3
        Week 37, Severe Problem, n=37
    3
        Week 49, Severe Problem, n=23
    1
        Week 61, Severe Problem, n=16
    1
        Week 73, Severe Problem, n=8
    0
        Week 85, Severe Problem, n=4
    0
        Week 97, Severe Problem, n=1
    0
        Follow-up, Severe Problem, n=30
    5
        Week 1, Extreme Problem, n=96
    0
        Week 3, Extreme Problem, n=90
    1
        Week 5, Extreme Problem, n=95
    1
        Week 7, Extreme Problem, n=86
    0
        Week 9, Extreme Problem, n=90
    2
        Week 13, Extreme Problem, n=73
    2
        Week 17, Extreme Problem, n=74
    1
        Week 21, Extreme Problem, n=63
    0
        Week 25, Extreme Problem, n=59
    0
        Week 37, Extreme Problem, n=37
    0
        Week 49, Extreme Problem, n=23
    0
        Week 61, Extreme Problem, n=16
    0
        Week 73, Extreme Problem, n=8
    0
        Week 85, Extreme Problem, n=4
    0
        Week 97, Extreme Problem, n=1
    0
        Follow-up, Extreme Problem, n=30
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With 5 Response Levels for EQ-5D-5L Self-Care Domain

    Close Top of page
    End point title
    Number of Subjects With 5 Response Levels for EQ-5D-5L Self-Care Domain
    End point description
    EQ-5D-5L: subjects rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D self-care domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All subjects reported under ‘Number of Subjects Analyzed’ contributed data to the table; however, may not have evaluable data for every row. Here, “n” signifies number of subjects evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
    End point values
    Talazoparib
    Number of subjects analysed
    97
    Units: Subjects
        Week 1, No Problem, n=95
    65
        Week 3, No Problem, n=90
    63
        Week 5, No Problem, n=95
    62
        Week 7, No Problem, n=85
    59
        Week 9, No Problem, n=90
    64
        Week 13, No Problem, n=73
    51
        Week 17, No Problem, n=74
    55
        Week 21, No Problem, n=63
    44
        Week 25, No Problem, n=59
    39
        Week 37, No Problem, n=37
    25
        Week 49, No Problem, n=23
    18
        Week 61, No Problem, n=16
    11
        Week 73, No Problem, n=8
    7
        Week 85, No Problem, n=4
    4
        Week 97, No Problem, n=1
    1
        Follow-up, No Problem, n=30
    19
        Week 1, Slight Problem, n=95
    18
        Week 3, Slight Problem, n=90
    17
        Week 5, Slight Problem, n=95
    20
        Week 7, Slight Problem, n=85
    14
        Week 9, Slight Problem, n=90
    15
        Week 13, Slight Problem, n=73
    14
        Week 17, Slight Problem, n=74
    13
        Week 21, Slight Problem, n=63
    12
        Week 25, Slight Problem, n=59
    13
        Week 37, Slight Problem, n=37
    10
        Week 49, Slight Problem, n=23
    4
        Week 61, Slight Problem, n=16
    5
        Week 73, Slight Problem, n=8
    1
        Week 85, Slight Problem, n=4
    0
        Week 97, Slight Problem, n=1
    0
        Follow-up Slight Problem, n=30
    3
        Week 1, Moderate Problem, n=95
    9
        Week 3, Moderate Problem, n=90
    8
        Week 5, Moderate Problem, n=95
    12
        Week 7, Moderate Problem, n=85
    12
        Week 9, Moderate Problem, n=90
    8
        Week 13, Moderate Problem, n=73
    3
        Week 17, Moderate Problem, n=74
    4
        Week 21, Moderate Problem, n=63
    5
        Week 25, Moderate Problem, n=59
    7
        Week 37, Moderate Problem, n=37
    2
        Week 49, Moderate Problem, n=23
    1
        Week 61, Moderate Problem, n=16
    0
        Week 73, Moderate Problem, n=8
    0
        Week 85, Moderate Problem, n=4
    0
        Week 97, Moderate Problem, n=1
    0
        Follow-up, Moderate Problem, n=30
    7
        Week 1, Severe Problem, n=95
    3
        Week 3, Severe Problem, n=90
    2
        Week 5, Severe Problem, n=95
    1
        Week 7, Severe Problem, n=85
    0
        Week 9, Severe Problem, n=90
    2
        Week 13, Severe Problem, n=73
    4
        Week 17, Severe Problem, n=74
    2
        Week 21, Severe Problem, n=63
    2
        Week 25, Severe Problem, n=59
    0
        Week 37, Severe Problem, n=37
    0
        Week 49, Severe Problem, n=23
    0
        Week 61, Severe Problem, n=16
    0
        Week 73, Severe Problem, n=8
    0
        Week 85, Severe Problem, n=4
    0
        Week 97, Severe Problem, n=1
    0
        Follow-up, Severe Problem, n=30
    1
        Week 1, Extreme Problem, n=95
    0
        Week 3, Extreme Problem, n=90
    0
        Week 5, Extreme Problem, n=95
    0
        Week 7, Extreme Problem, n=85
    0
        Week 9, Extreme Problem, n=90
    1
        Week 13, Extreme Problem, n=73
    1
        Week 17, Extreme Problem, n=74
    0
        Week 21, Extreme Problem, n=63
    0
        Week 25, Extreme Problem, n=59
    0
        Week 37, Extreme Problem, n=37
    0
        Week 49, Extreme Problem, n=23
    0
        Week 61, Extreme Problem, n=16
    0
        Week 73, Extreme Problem, n=8
    0
        Week 85, Extreme Problem, n=4
    0
        Week 97, Extreme Problem, n=1
    0
        Follow-up, Extreme Problem, n=30
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With 5 Response Levels for EQ-5D-5L Usual Activity Domain

    Close Top of page
    End point title
    Number of Subjects With 5 Response Levels for EQ-5D-5L Usual Activity Domain
    End point description
    EQ-5D-5L: subjects rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D usual activities domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All subjects reported under ‘Number of Subjects Analyzed’ contributed data to the table; however, may not have evaluable data for every row. Here, “n” signifies number of subjects evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
    End point values
    Talazoparib
    Number of subjects analysed
    97
    Units: Subjects
        Week 1, No Problem, n=96
    33
        Week 3, No Problem, n=90
    33
        Week 5, No Problem, n=95
    36
        Week 7, No Problem, n=85
    34
        Week 9, No Problem, n=90
    41
        Week 13, No Problem, n=73
    36
        Week 17, No Problem, n=74
    36
        Week 21, No Problem, n=63
    35
        Week 25, No Problem, n=59
    29
        Week 37, No Problem, n=37
    17
        Week 49, No Problem, n=23
    11
        Week 61, No Problem, n=16
    8
        Week 73, No Problem, n=8
    6
        Week 85, No Problem, n=4
    2
        Week 97, No Problem, n=1
    1
        Follow-up, No Problem, n=30
    10
        Week 1, Slight Problem, n=96
    30
        Week 3, Slight Problem, n=90
    26
        Week 5, Slight Problem, n=95
    30
        Week 7, Slight Problem, n=85
    24
        Week 9, Slight Problem, n=90
    26
        Week 13, Slight Problem, n=73
    22
        Week 17, Slight Problem, n=74
    21
        Week 21, Slight Problem, n=63
    13
        Week 25, Slight Problem, n=59
    12
        Week 37, Slight Problem, n=37
    10
        Week 49, Slight Problem, n=23
    5
        Week 61, Slight Problem, n=16
    4
        Week 73, Slight Problem, n=8
    0
        Week 85, Slight Problem, n=4
    2
        Week 97, Slight Problem, n=1
    0
        Follow-up, Slight Problem, n=30
    10
        Week 1, Moderate Problem, n=96
    19
        Week 3, Moderate Problem, n=90
    22
        Week 5, Moderate Problem, n=95
    21
        Week 7, Moderate Problem, n=85
    22
        Week 9, Moderate Problem, n=90
    15
        Week 13, Moderate Problem, n=73
    10
        Week 17, Moderate Problem, n=74
    14
        Week 21, Moderate Problem, n=63
    12
        Week 25, Moderate Problem, n=59
    12
        Week 37, Moderate Problem, n=37
    7
        Week 49, Moderate Problem, n=23
    6
        Week 61, Moderate Problem, n=16
    3
        Week 73, Moderate Problem, n=8
    2
        Week 85, Moderate Problem, n=4
    0
        Week 97, Moderate Problem, n=1
    0
        Follow-up, Moderate Problem, n=30
    5
        Week 1, Severe Problem, n=96
    10
        Week 3, Severe Problem, n=90
    8
        Week 5, Severe Problem, n=95
    4
        Week 7, Severe Problem, n=85
    3
        Week 9, Severe Problem, n=90
    5
        Week 13, Severe Problem, n=73
    2
        Week 17, Severe Problem, n=74
    2
        Week 21, Severe Problem, n=63
    2
        Week 25, Severe Problem, n=59
    6
        Week 37, Severe Problem, n=37
    3
        Week 49, Severe Problem, n=23
    1
        Week 61, Severe Problem, n=16
    1
        Week 73, Severe Problem, n=8
    0
        Week 85, Severe Problem, n=4
    0
        Week 97, Severe Problem, n=1
    0
        Follow-up, Severe Problem, n=30
    5
        Week 1, Extreme Problem, n=96
    4
        Week 3, Extreme Problem, n=90
    1
        Week 5, Extreme Problem, n=95
    4
        Week 7, Extreme Problem, n=85
    2
        Week 9, Extreme Problem, n=90
    3
        Week 13, Extreme Problem, n=73
    3
        Week 17, Extreme Problem, n=74
    1
        Week 21, Extreme Problem, n=63
    1
        Week 25, Extreme Problem, n=59
    0
        Week 37, Extreme Problem, n=37
    0
        Week 49, Extreme Problem, n=23
    0
        Week 61, Extreme Problem, n=16
    0
        Week 73, Extreme Problem, n=8
    0
        Week 85, Extreme Problem, n=4
    0
        Week 97, Extreme Problem, n=1
    0
        Follow-up, Extreme Problem, n=30
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain

    Close Top of page
    End point title
    Number of Subjects With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain
    End point description
    EQ-5D-5L: subjects rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D pain and discomfort domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All subjects reported under ‘Number of Subjects Analyzed’ contributed data to the table; however, may not have evaluable data for every row. Here, “n” signifies number of subjects evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
    End point values
    Talazoparib
    Number of subjects analysed
    97
    Units: Subjects
        Week 1, No Problem, n=96
    15
        Week 3, No Problem, n=90
    25
        Week 5, No Problem, n=95
    30
        Week 7, No Problem, n=85
    26
        Week 9, No Problem, n=90
    34
        Week 13, No Problem, n=73
    23
        Week 17, No Problem, n=74
    27
        Week 21, No Problem, n=63
    24
        Week 25, No Problem, n=59
    22
        Week 37, No Problem, n=37
    12
        Week 49, No Problem, n=23
    11
        Week 61, No Problem, n=16
    6
        Week 73, No Problem, n=8
    2
        Week 85, No Problem, n=4
    2
        Week 9, No Problem, n=1
    0
        Follow-up, No Problem, n=30
    9
        Week 1, Slight Problem, n=96
    35
        Week 3, Slight Problem, n=90
    25
        Week 5, Slight Problem, n=95
    27
        Week 7, Slight Problem, n=85
    32
        Week 9, Slight Problem, n=90
    29
        Week 13, Slight Problem, n=73
    33
        Week 17, Slight Problem, n=74
    25
        Week 21, Slight Problem, n=63
    19
        Week 25, Slight Problem, n=59
    17
        Week 37, Slight Problem, n=37
    12
        Week 49, Slight Problem, n=23
    3
        Week 61, Slight Problem, n=16
    5
        Week 73, Slight Problem, n=8
    4
        Week 85, Slight Problem, n=4
    2
        Week 97, Slight Problem, n=1
    1
        Follow-up, Slight Problem, n=30
    8
        Week 1, Moderate Problem, n=96
    30
        Week 3, Moderate Problem, n=90
    32
        Week 5, Moderate Problem, n=95
    29
        Week 7, Moderate Problem, n=85
    23
        Week 9, Moderate Problem, n=90
    21
        Week 13, Moderate Problem, n=73
    12
        Week 17, Moderate Problem, n=74
    17
        Week 21, Moderate Problem, n=63
    17
        Week 25, Moderate Problem, n=59
    17
        Week 37, Moderate Problem, n=37
    10
        Week 49, Moderate Problem, n=23
    7
        Week 61, Moderate Problem, n=16
    5
        Week 73, Moderate Problem, n=8
    1
        Week 85, Moderate Problem, n=4
    0
        Week 97, Moderate Problem, n=1
    0
        Follow-up, Moderate Problem, n=30
    9
        Week 1, Severe Problem, n=96
    16
        Week 3, Severe Problem, n=90
    8
        Week 5, Severe Problem, n=95
    9
        Week 7, Severe Problem, n=85
    4
        Week 9, Severe Problem, n=90
    6
        Week 13, Severe Problem, n=73
    3
        Week 17, Severe Problem, n=74
    5
        Week 21, Severe Problem, n=63
    2
        Week 25, Severe Problem, n=59
    3
        Week 37, Severe Problem, n=37
    3
        Week 49, Severe Problem, n=23
    2
        Week 61, Severe Problem, n=16
    0
        Week 73, Severe Problem, n=8
    1
        Week 85, Severe Problem, n=4
    0
        Week 97, Severe Problem, n=1
    0
        Follow-up, Severe Problem, n=30
    4
        Week 1, Extreme Problem, n=96
    0
        Week 3, Extreme Problem, n=90
    0
        Week 5, Extreme Problem, n=95
    0
        Week 7, Extreme Problem, n=85
    0
        Week 9, Extreme Problem, n=90
    0
        Week 13, Extreme Problem, n=73
    2
        Week 17, Extreme Problem, n=74
    0
        Week 21, Extreme Problem, n=63
    1
        Week 25, Extreme Problem, n=59
    0
        Week 37, Extreme Problem, n=37
    0
        Week 49, Extreme Problem, n=23
    0
        Week 61, Extreme Problem, n=16
    0
        Week 73, Extreme Problem, n=8
    0
        Week 85, Extreme Problem, n=4
    0
        Week 97, Extreme Problem, n=1
    0
        Follow-up, Extreme Problem, n=30
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain

    Close Top of page
    End point title
    Number of Subjects With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain
    End point description
    EQ-5D-5L: subjects rated assessed level of current health using 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety, and depression. EQ-5D anxiety and depression domain had 5 responses: no problem, slight problem, moderate problem, severe problem and extreme problem. Final analyses for this endpoint was till the cutoff date 04 September 2020. All subjects from the DDR deficient measurable disease population with a baseline PRO assessment and at least 1 post-baseline PRO assessment prior to the end of treatment. All subjects reported under ‘Number of Subjects Analyzed’ contributed data to the table; however, may not have evaluable data for every row. Here, “n” signifies number of subjects evaluable for specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
    End point values
    Talazoparib
    Number of subjects analysed
    97
    Units: Subjects
        Week 1, No Problem, n=96
    48
        Week 3, No Problem, n=90
    45
        Week 5, No Problem, n=95
    43
        Week 7, No Problem, n=85
    45
        Week 9, No Problem, n=90
    49
        Week 13, No Problem, n=73
    40
        Week 17, No Problem, n=74
    40
        Week 21, No Problem, n=63
    41
        Week 25, No Problem, n=59
    29
        Week 37, No Problem, n=37
    20
        Week 49, No Problem, n=23
    12
        Week 61, No Problem, n=16
    8
        Week 73, No Problem, n=8
    4
        Week 85, No Problem, n=4
    2
        Week 97, No Problem, n=1
    1
        Follow-up, No Problem, n=30
    16
        Week 1, Slight Problem, n=96
    30
        Week 3, Slight Problem, n=90
    27
        Week 5, Slight Problem, n=95
    35
        Week 7, Slight Problem, n=85
    30
        Week 9, Slight Problem, n=90
    27
        Week 13, Slight Problem, n=73
    23
        Week 17, Slight Problem, n=74
    21
        Week 21, Slight Problem, n=63
    15
        Week 25, Slight Problem, n=59
    24
        Week 37, Slight Problem, n=37
    14
        Week 49, Slight Problem, n=23
    9
        Week 61, Slight Problem, n=16
    8
        Week 73, Slight Problem, n=8
    3
        Week 85, Slight Problem, n=4
    2
        Week 97, Slight Problem, n=1
    0
        Follow-up, Slight Problem, n=30
    6
        Week 1, Moderate Problem, n=96
    18
        Week 3, Moderate Problem, n=90
    17
        Week 5, Moderate Problem, n=95
    16
        Week 7, Moderate Problem, n=85
    7
        Week 9, Moderate Problem, n=90
    12
        Week 13, Moderate Problem, n=73
    6
        Week 17, Moderate Problem, n=74
    12
        Week 21, Moderate Problem, n=63
    7
        Week 25, Moderate Problem, n=59
    4
        Week 37, Moderate Problem, n=37
    3
        Week 49, Moderate Problem, n=23
    2
        Week 61, Moderate Problem, n=16
    0
        Week 73, Moderate Problem, n=8
    1
        Week 85, Moderate Problem, n=4
    0
        Week 97, Moderate Problem, n=1
    0
        Follow-up, Moderate Problem, n=30
    5
        Week 1, Severe Problem, n=96
    0
        Week 3, Severe Problem, n=90
    1
        Week 5, Severe Problem, n=95
    0
        Week 7, Severe Problem, n=85
    2
        Week 9, Severe Problem, n=90
    1
        Week 13, Severe Problem, n=73
    2
        Week 17, Severe Problem, n=74
    0
        Week 21, Severe Problem, n=63
    0
        Week 25, Severe Problem, n=59
    2
        Week 37, Severe Problem, n=37
    0
        Week 49, Severe Problem, n=23
    0
        Week 61, Severe Problem, n=16
    0
        Week 73, Severe Problem, n=8
    0
        Week 85, Severe Problem, n=4
    0
        Week 97, Severe Problem, n=1
    0
        Follow-up, Severe Problem, n=30
    3
        Week 1, Extreme Problem, n=96
    0
        Week 3, Extreme Problem, n=90
    0
        Week 5, Extreme Problem, n=95
    1
        Week 7, Extreme Problem, n=85
    1
        Week 9, Extreme Problem, n=90
    1
        Week 13, Extreme Problem, n=73
    2
        Week 17, Extreme Problem, n=74
    1
        Week 21, Extreme Problem, n=63
    0
        Week 25, Extreme Problem, n=59
    0
        Week 37, Extreme Problem, n=37
    0
        Week 49, Extreme Problem, n=23
    0
        Week 61, Extreme Problem, n=16
    0
        Week 73, Extreme Problem, n=8
    0
        Week 85, Extreme Problem, n=4
    0
        Week 97, Extreme Problem, n=1
    0
        Follow-up, Extreme Problem, n=30
    0
    No statistical analyses for this end point

    Secondary: Pre-dose Plasma Concentration (Ctrough) of Talazoparib

    Close Top of page
    End point title
    Pre-dose Plasma Concentration (Ctrough) of Talazoparib
    End point description
    Ctrough was defined as pre-dose plasma concentration during dosing and observed directly from data. Pharmacokinetic (PK) population included all subjects from the safety population who had at least 1 reportable drug concentration data point. Here, “Number of Subjects Analyzed” signifies subjects evaluable for this endpoint and "n” signifies subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Pre-dose at Week 1, 5, 9 and 13
    End point values
    Talazoparib
    Number of subjects analysed
    92
    Units: nanograms per milliliter
    geometric mean (geometric coefficient of variation)
        At Week 1, n=92
    2631.898 ± 23.2043
        At Week 5, n=82
    4748.147 ± 63.2488
        At Week 9, n=71
    4213.250 ± 52.8028
        At Week 13, n=55
    4378.123 ± 47.5360
    No statistical analyses for this end point

    Secondary: Post-dose Plasma Concentration (Ctrough) of Talazoparib

    Close Top of page
    End point title
    Post-dose Plasma Concentration (Ctrough) of Talazoparib
    End point description
    Plasma concentration was measured 2 hours after dosing and observed directly from data. PK population included all subjects from the safety population who had at least 1 reportable drug concentration data point. Here, “Number of Subjects Analyzed” signifies subjects evaluable for this endpoint and "n” signifies subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    2 hours post-dose at Week 1 and 5
    End point values
    Talazoparib
    Number of subjects analysed
    31
    Units: nanograms per milliliter
    geometric mean (geometric coefficient of variation)
        At week 1, n=25
    2289.540 ± 51.0724
        At Week 5, n=31
    10713.918 ± 49.4248
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    SAEs and Non-SAEs: Baseline up to 28 days after last dose of study drug (maximum up to 37 months); All-cause mortality: During study included safety follow up and beyond that (approximately 69 months of study)
    Adverse event reporting additional description
    Same event may appear as both an AE and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event. Safety population set was analyzed.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Talazoparib
    Reporting group description
    Subjects received talazoparib 1 milligram per day (mg/day) orally until radiographic progression that was determined by independent central review, unacceptable toxicity, withdrawal of consent, or death. Talazoparib was continued upon disease progression only if, in the opinion of the investigator the subjects was clinically benefitting, no new concurrent systemic therapy was initiated, and the sponsor was notified. Maximum duration of treatment was approximately 36 months.

    Serious adverse events
    Talazoparib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    51 / 127 (40.16%)
         number of deaths (all causes)
    45
         number of deaths resulting from adverse events
    11
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Neoplasm progression
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metastases to spine
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Disease progression
         subjects affected / exposed
    5 / 127 (3.94%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    General physical health deterioration
         subjects affected / exposed
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Pain
         subjects affected / exposed
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Penile pain
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    9 / 127 (7.09%)
         occurrences causally related to treatment / all
    1 / 9
         deaths causally related to treatment / all
    0 / 1
    Dyspnoea
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Platelet count decreased
         subjects affected / exposed
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Overdose
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Hemianopia
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 127 (0.79%)
         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
    9 / 127 (7.09%)
         occurrences causally related to treatment / all
    7 / 10
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Back pain
         subjects affected / exposed
    4 / 127 (3.15%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    4 / 127 (3.15%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 127 (2.36%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Talazoparib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    120 / 127 (94.49%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    12 / 127 (9.45%)
         occurrences all number
    13
    Hypertension
         subjects affected / exposed
    7 / 127 (5.51%)
         occurrences all number
    9
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    32 / 127 (25.20%)
         occurrences all number
    62
    Pyrexia
         subjects affected / exposed
    10 / 127 (7.87%)
         occurrences all number
    18
    Oedema peripheral
         subjects affected / exposed
    23 / 127 (18.11%)
         occurrences all number
    32
    Fatigue
         subjects affected / exposed
    28 / 127 (22.05%)
         occurrences all number
    39
    Chest pain
         subjects affected / exposed
    9 / 127 (7.09%)
         occurrences all number
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 127 (7.87%)
         occurrences all number
    10
    Dyspnoea
         subjects affected / exposed
    17 / 127 (13.39%)
         occurrences all number
    22
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    8 / 127 (6.30%)
         occurrences all number
    10
    Investigations
    Lymphocyte count decreased
         subjects affected / exposed
    11 / 127 (8.66%)
         occurrences all number
    25
    Aspartate aminotransferase increased
         subjects affected / exposed
    8 / 127 (6.30%)
         occurrences all number
    10
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 127 (5.51%)
         occurrences all number
    7
    White blood cell count decreased
         subjects affected / exposed
    13 / 127 (10.24%)
         occurrences all number
    32
    Weight decreased
         subjects affected / exposed
    7 / 127 (5.51%)
         occurrences all number
    7
    Platelet count decreased
         subjects affected / exposed
    27 / 127 (21.26%)
         occurrences all number
    80
    Neutrophil count decreased
         subjects affected / exposed
    22 / 127 (17.32%)
         occurrences all number
    43
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    9 / 127 (7.09%)
         occurrences all number
    9
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    8 / 127 (6.30%)
         occurrences all number
    8
    Dizziness
         subjects affected / exposed
    15 / 127 (11.81%)
         occurrences all number
    20
    Paraesthesia
         subjects affected / exposed
    8 / 127 (6.30%)
         occurrences all number
    12
    Headache
         subjects affected / exposed
    9 / 127 (7.09%)
         occurrences all number
    11
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    67 / 127 (52.76%)
         occurrences all number
    208
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    27 / 127 (21.26%)
         occurrences all number
    29
    Diarrhoea
         subjects affected / exposed
    22 / 127 (17.32%)
         occurrences all number
    28
    Nausea
         subjects affected / exposed
    45 / 127 (35.43%)
         occurrences all number
    65
    Vomiting
         subjects affected / exposed
    16 / 127 (12.60%)
         occurrences all number
    17
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    8 / 127 (6.30%)
         occurrences all number
    10
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    13 / 127 (10.24%)
         occurrences all number
    17
    Bone pain
         subjects affected / exposed
    9 / 127 (7.09%)
         occurrences all number
    12
    Back pain
         subjects affected / exposed
    19 / 127 (14.96%)
         occurrences all number
    31
    Arthralgia
         subjects affected / exposed
    19 / 127 (14.96%)
         occurrences all number
    30
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 127 (6.30%)
         occurrences all number
    8
    Urinary tract infection
         subjects affected / exposed
    10 / 127 (7.87%)
         occurrences all number
    15
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    38 / 127 (29.92%)
         occurrences all number
    57

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Mar 2017
    Safety related updates included: - Increased the frequency of clinical laboratory tests after week 25 from every 12 weeks to every 8 weeks for increased patient safety and consistency across talazoparib studies. - Added guidance for dose modification of talazoparib and updates talazoparib product information for increased patient safety and consistency across talazoparib studies.
    15 Nov 2018
    The primary purpose of this Amendment is to address updated information reported in the August 2018 version of the Talazoparib Investigator’s Brochure. In addition, guidance for talazoparib dose modifications due to adverse events was updated to align with the Risk Management Committee (RMC) recommendations and the proposed regional labels. Changes included: • Extension of the time required, for contraceptive use and for patients to refrain from sperm donation, from 105 days to 4 months. • Clarification/changes regarding prior and concomitant medications. • Clarifications to responses to adverse events, including talazoparib dose modifications. • Updated safety and efficacy data from clinical studies in patients that have taken talazoparib. • Updated pharmacokinetics data. • Update to the benefits and risks assessment. • The section pertaining to medication errors was updated to address talazoparib overdose.
    22 Sep 2022
    Safety related updates included: Talazoparib Benefits and Risks Assessment section was amended with updated information reported in the May 2021 version of the Talazoparib Investigator's Brochure.

    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
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA