Trial Outcomes & Findings for STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS (NCT NCT04635631)

NCT ID: NCT04635631

Last Updated: 2023-10-10

Results Overview

Maximum plasma concentration of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9. Cmax was directly observed from data.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 15 participants
• Primary outcome timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing
• Results posted on: 2023-10-10

Participant Flow

A total of 15 participants were enrolled and received talazoparib 1 mg once daily (QD).

Participant milestones

Measure	Talazoparib 1 mg QD Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1.
Overall Study STARTED	15
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	Talazoparib 1 mg QD Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1.
Overall Study Adverse Event	1
Overall Study Progressive disease	13
Overall Study Withdrawal by Subject	1

Baseline Characteristics

STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS

Baseline characteristics by cohort

Measure	Talazoparib 1 mg QD n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1.
Age, Continuous	53 years n=5 Participants
Age, Customized 18 to <45 years	4 Participants n=5 Participants
Age, Customized 45 to <65 years	8 Participants n=5 Participants
Age, Customized >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	15 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	15 Participants n=5 Participants
Race/Ethnicity, Customized Other (Not Chinese)	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing

Population: The analysis population included all participants enrolled and treated who had at least 1 of the pharmacokinetic (PK) parameters of interest in the single-dose and/or multiple dose PK part.

Maximum plasma concentration of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9. Cmax was directly observed from data.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Maximum Observed Concentration (Cmax) of Talazoparib Following Single Oral Dose	8.506 nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 41

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest in the single-dose and/or multiple dose PK part.

Time to reach Cmax (maximum plasma concentration) of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Time to Cmax (Tmax) of Talazoparib Following Single Oral Dose	1.90 hours Interval 0.517 to 7.63

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest in the single-dose and/or multiple dose PK part.

Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Area Under Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Talazoparib Following Single Oral Dose	172.0 ng*hr/mL Geometric Coefficient of Variation 32

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest in the single-dose and/or multiple dose PK part.

Area under the plasma concentration versus time curve from time zero to the time tau (=24 hours) of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of Talazoparib Following Single Oral Dose	86.54 ng*hr/mL Geometric Coefficient of Variation 29

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this outcome measure (OM).

Apparent oral clearance of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F is calculated as dose/AUCinf. AUCinf = area under the plasma concentration versus time curve from time zero extrapolated to infinite time.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=10 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Apparent Oral Clearance (CL/F) of Talazoparib Following Single Oral Dose	4.798 liter/hour (L/hr) Geometric Coefficient of Variation 31

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this OM.

Apparent volume of distribution of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9. Vz/F is calculated as Dose/(AUCinf * kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUCinf is area under the plasma concentration versus time curve from time zero extrapolated to infinite time.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=10 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Apparent Volume of Distribution (Vz/F) of Talazoparib Following Single Oral Dose	456.8 Liter Geometric Coefficient of Variation 37

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this OM.

Terminal half-life of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9. t1/2 is defined as the time for plasma concentration of drug to decrease by one half.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=10 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Terminal Half-Life (t1/2) of Talazoparib Following Single Oral Dose	67.00 hours Standard Deviation 11.779

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this OM.

Area under the plasma concentration versus time curve from time zero extrapolated to infinite time of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=10 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Talazoparib Following Single Oral Dose	208.3 ng*hr/mL Geometric Coefficient of Variation 31

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed data to this OM.

Maximum plasma concentration of talazoparib at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=12 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Cmax of Talazoparib Following Multiple Oral Doses (Steady State)	14.35 ng/mL Geometric Coefficient of Variation 169

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed data to this OM.

Time for Cmax of talazoparib at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=12 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Tmax of Talazoparib Following Multiple Oral Doses (Steady State)	1.85 hours Interval 0.533 to 23.7

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed data to this OM.

Minimum plasma concentration observed during the dosing interval at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=12 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Minimum Plasma Concentration (Cmin) of Talazoparib Following Multiple Oral Doses (Steady State)	2.616 ng/mL Geometric Coefficient of Variation 95

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this OM.

Area under the plasma concentration versus time curve within a dosing interval of tau (=24 hours) at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=12 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
AUCtau of Talazoparib Following Multiple Oral Doses (Steady State)	147.8 ng*hr/mL Geometric Coefficient of Variation 123

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this OM.

Apparent clearance at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state CL/F is calculated as dose/AUCtau. AUCtau = area under the plasma concentration versus time curve within a dosing interval of tau (=24 hours) at steady state after multiple doses.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=12 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
CL/F of Talazoparib Following Multiple Oral Doses (Steady State)	6.770 L/hr Geometric Coefficient of Variation 123

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this OM.

Observed accumulation ratio at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22. Rac is calculated as AUCtau/AUCsd,tau, where AUCtau = Area under the plasma concentration versus time curve within a dosing interval of tau (=24 hours) at steady state after multiple doses, AUCsd,tau = area under the plasma concentration versus time curve from time zero extrapolated to the time tau (=24 hours) after single dose.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=12 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Observed Accumulation Ratio (Rac) of Talazoparib Following Multiple Oral Doses (Steady State)	1.733 ratio Geometric Coefficient of Variation 127

PRIMARY outcome

Timeframe: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.

Population: The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this OM.

Steady-state accumulation ratio after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22. Rss is calculated as AUCtau/AUCinf, where AUCtau = Area under the plasma concentration versus time curve within a dosing interval of tau (=24 hours) at steady state after multiple doses, AUCinf = Area under the plasma concentration versus time curve from time zero extrapolated to infinite time after single dose.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=8 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Steady-State Accumulation Ratio (Rss) of Talazoparib Following Multiple Oral Doses (Steady State)	0.6958 ratio Geometric Coefficient of Variation 192

SECONDARY outcome

Timeframe: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1(mild)=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) All-causality TEAEs leading to discontinuation from talazoparib	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) All-causality TEAEs	14 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatment-related TEAEs	13 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Grade 3 or 4 all-causality TEAEs	10 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Grade 3 or 4 treatment-related TEAEs	6 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Grade 5 TEAEs (TEAEs leading to death)	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) All-causality TEAEs leading to dose interruption of talazoparib	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatment-related TEAEs leading to dose interruption of talazoparib	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) All-causality TEAEs leading to dose reduction of talazoparib	5 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatment-related TEAEs leading to dose reduction of talazoparib	5 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Treatment-related TEAEs leading to discontinuation from talazoparib	1 Participants

SECONDARY outcome

Timeframe: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With Serious Adverse Events (SAEs) All-causality SAE	3 Participants
Number of Participants With Serious Adverse Events (SAEs) Treatment-related SAE	3 Participants

SECONDARY outcome

Timeframe: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated. Treatment-related TEAEs were determined by the investigator. Grade 3 or 4 TEAEs reported by at least 1 participant are reported here.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Anaemia	4 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Gamma-glutamyltransferase increased	3 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 4 Gamma-glutamyltransferase increased	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Neutrophil count decreased	3 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 4 Neutrophil count decreased	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Platelet count decreased	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 4 Platelet count decreased	2 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Aspartate aminotransferase increased	2 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Abdominal distension	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Blood bilirubin increased	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Hypercholesterolaemia	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Hyperglycaemia	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 4 Hypernatraemia	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 4 Hyperuricaemia	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Hypokalaemia	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Hyponatraemia	1 Participants
Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade Grade 3 Neutropenia	1 Participants

SECONDARY outcome

Timeframe: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated. Treatment-related TEAEs were determined by the investigator. Grade 3 or 4 treatment-related TEAEs reported by at least 1 participant are reported here.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade Grade 3 Anaemia	4 Participants
Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade Grade 3 Neutrophil count decreased	3 Participants
Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade Grade 4 Neutrophil count decreased	1 Participants
Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade Grade 3 Platelet count decreased	1 Participants
Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade Grade 4 Platelet count decreased	2 Participants
Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade Grade 3 Hyponatraemia	1 Participants
Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade Grade 3 Neutropenia	1 Participants

SECONDARY outcome

Timeframe: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Treatment-related TEAEs were determined by the investigator.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT All-causality Anaemia leading to dose interruption	1 Participants
Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT Treatment-related Anaemia leading to dose interruption	1 Participants
Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT All-causality Aspartate aminotransferase increased leading to dose interruption	1 Participants
Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT All-causality Neutrophil count decreased leading to dose interruption	1 Participants
Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT Treatment-related Neutrophil count decreased leading to dose interruption	1 Participants
Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT All-causality Platelet count decreased leading to dose interruption	1 Participants
Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT Treatment-related Platelet count decreased leading to dose interruption	1 Participants

SECONDARY outcome

Timeframe: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Treatment-related TEAEs were determined by the investigator.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT All-causality Anaemia leading to dose reduction	3 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT Treatment-related Anaemia leading to dose reduction	3 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT All-causality Neutrophil count decreased leading to dose reduction	3 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT Treatment-related Neutrophil count decreased leading to dose reduction	3 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT All-causality Platelet count decreased leading to dose reduction	3 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT Treatment-related Platelet count decreased leading to dose reduction	3 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT All-causality Neutropenia leading to dose reduction	1 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT Treatment-related Neutropenia leading to dose reduction	1 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT All-causality Hypernatraemia leading to dose reduction	1 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT All-causality Hyponatraemia leading to dose reduction	1 Participants
Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT Treatment-related Hyponatraemia leading to dose reduction	1 Participants

SECONDARY outcome

Timeframe: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Treatment-related TEAEs were determined by the investigator.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With TEAEs Leading to Discontinuation From Talazoparib by PT All-causality Neutrophil count decreased leading to discontinuation from talazoparib	1 Participants
Number of Participants With TEAEs Leading to Discontinuation From Talazoparib by PT Treatment-related Neutrophil count decreased leading to discontinuation from talazoparib	1 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Hematology lab parameters included hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell (WBC) count, neutrophils%, eosinophils%, monocytes%, basophils%, lymphocytes%. Grades of lab abnormalities were defined per NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL;Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=life-threatening consequences, urgent intervention indicated. On-treatment is defined as time from first dose date of talazoparib through at least 28 days after last dose or start day of new anti-cancer therapy minus 1 day. Shifts meeting criteria and reported in at least 1 participant are reported in this OM.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Anemia: Grade 0 to Grade 3	3 Participants
Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Anemia: Grade 1 to Grade 3	1 Participants
Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Lymphocyte count decreased: Grade 0 to Grade 3	1 Participants
Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Neutrophil count decreased: Grade 0 to Grade 3	5 Participants
Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Neutrophil count decreased: Grade 0 to Grade 4	1 Participants
Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Platelet count decreased: Grade 0 to Grade 3	1 Participants
Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Platelet count decreased: Grade 0 to Grade 4	2 Participants
Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade White blood cell decreased: Grade 0 to Grade 3	1 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Chemistry lab parameters included blood urea nitrogen or urea,creatinine,glucose (fasting),calcium,sodium,potassium,magnesium,chloride,aspartate aminotransferase,alanine aminotransferase,total bilirubin,alkaline phosphatase,uric acid,albumin,total protein,creatinine clearance. Grades of lab results were defined per NCI CTCAE v4.03.Grade 1=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL;Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=life-threatening consequences, urgent intervention indicated.On-treatment=time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day. Shifts meeting criteria and reported in at least 1 participant are reported.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Chemistry Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Aspartate aminotransferase: Grade 1 to Grade 3	2 Participants
Number of Participants With On-Treatment Chemistry Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Hyperglycemia: Grade 1 to Grade 3	1 Participants
Number of Participants With On-Treatment Chemistry Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Alkaline phosphatase increased: Grade 0 to Grade 3	1 Participants
Number of Participants With On-Treatment Chemistry Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Blood bilirubin increased: Grade 0 to Grade 3	1 Participants
Number of Participants With On-Treatment Chemistry Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Hypernatremia: Grade 0 to Grade 4	1 Participants
Number of Participants With On-Treatment Chemistry Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Hypokalemia: Grade 0 to Grade 3	1 Participants
Number of Participants With On-Treatment Chemistry Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Hyponatremia: Grade 0 to Grade 3	1 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention. Number of participants analyzed = number of participant evaluable for this OM.

Urinalysis examined pH,glucose,protein,blood,ketones,nitrites,leukocyte esterase/leukocytes,urobilinogen,urine bilirubin,microscopy. Grades of lab results were defined by NCI CTCAE v4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL;Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=life-threatening consequences, urgent intervention indicated. On-treatment=time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day. This OM is based only on lab data. Grade 4 proteinuria cannot be assessed based only on lab data, so is not applicable/not reported.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=13 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Urinalysis Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Protenuria: Grade 0 to Grade 3	0 Participants
Number of Participants With On-Treatment Urinalysis Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Protenuria: Grade 1 to Grade 3	0 Participants
Number of Participants With On-Treatment Urinalysis Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade Protenuria: Grade 2 to Grade 3	0 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Vital signs data included systolic and diastolic blood pressure (BP), pulse rate, respiratory rate (RR), temperature and weight. BP and pulse rate were recorded in sitting position. Potentially clinically significant vital signs abnormalities are defined as: systolic BP absolute result >180 mmHg and increase from baseline ≥40 mmHg, absolute result <90 mmHg and decrease from baseline >30 mmHg; diastolic BP absolute result >110 mmHg and increase from baseline ≥30 mmHg, absolute result <50 mmHg and decrease from baseline >20 mmHg, increase from baseline ≥20 mmHg; pulse rate absolute result >120 beats per minute (bpm) and increase from baseline >30 bpm, absolute result <50 bpm and decrease from baseline > 20 bpm; weight >10% decrease from baseline. Participants with vital signs data meeting any criteria above are reported in this OM if any. On-treatment is defined as time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Vital Signs Data Meeting Pre-Specified Criteria for Potentially Clinically Significant Results	1 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Standard 12-lead electrocardiograms (ECGs) utilizing limb leads (with a 10 second rhythm strip) were collected using an ECG machine that automatically calculated the heart rate and measured PR, RR, QT intervals, QTc, QTcF and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes. On-treatment is defined as the time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category QTcB interval value <=450 millisecond (msec)	9 Participants
Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category QTcB interval value >450 msec and <=480 msec	5 Participants
Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category QTcB interval value >480 msec and <=500 msec	0 Participants
Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category QTcB interval value >500 msec	1 Participants
Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category QTcF interval value <=450 msec	14 Participants
Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category QTcF interval value >450 msec and <=480 msec	1 Participants
Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category QTcF interval value >480 msec and <=500 msec	0 Participants
Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category QTcF interval value>500 msec	0 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Standard 12-lead electrocardiograms (ECGs) utilizing limb leads (with a 10 second rhythm strip) were collected using an ECG machine that automatically calculated the heart rate and measured PR, RR, QT intervals, QTc, QTcF and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes. On-treatment is defined as the time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Maximum Increase From Baseline in QTcB and QTcF Data by Category QTcB interval increase from baseline <=30 msec	9 Participants
Number of Participants With On-Treatment Maximum Increase From Baseline in QTcB and QTcF Data by Category QTcB interval increase from baseline >30 msec and <=60 msec	2 Participants
Number of Participants With On-Treatment Maximum Increase From Baseline in QTcB and QTcF Data by Category QTcB interval increase from baseline >60 msec	4 Participants
Number of Participants With On-Treatment Maximum Increase From Baseline in QTcB and QTcF Data by Category QTcF interval increase from baseline <=30 msec	9 Participants
Number of Participants With On-Treatment Maximum Increase From Baseline in QTcB and QTcF Data by Category QTcF interval increase from baseline >30 msec and <=60 msec	3 Participants
Number of Participants With On-Treatment Maximum Increase From Baseline in QTcB and QTcF Data by Category QTcF interval increase from baseline >60 msec	3 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose/start day of new anti-cancer drug therapy minus 1 day (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Concomitant medications or nondrug treatments/procedures were defined as medications or nondrug treatments/procedures, other than study intervention, which started prior to first dose date of study treatment and continued on on-treatment period as well as those started during the on-treatment period. On-treatment is defined as the time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Concomitant Medications	14 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose/start day of new anti-cancer drug therapy minus 1 day (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Concomitant medications or nondrug treatments/procedures were defined as medications or nondrug treatments/procedures, other than study intervention, which started prior to first dose date of study treatment and continued on on-treatment period as well as those started during the on-treatment period. On-treatment is defined as the time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day. On-treatment concomitant medications reported in at least 20% participants are reported for this OM.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Concomitant Medications With Frequency >=20% by PT Recombinant human thrombopoietin	3 Participants
Number of Participants With On-Treatment Concomitant Medications With Frequency >=20% by PT Lidocaine	3 Participants
Number of Participants With On-Treatment Concomitant Medications With Frequency >=20% by PT Glucose	3 Participants
Number of Participants With On-Treatment Concomitant Medications With Frequency >=20% by PT Dexamethasone sodium phosphate	3 Participants
Number of Participants With On-Treatment Concomitant Medications With Frequency >=20% by PT Granulocyte colony stimulating factor	3 Participants
Number of Participants With On-Treatment Concomitant Medications With Frequency >=20% by PT Herbal preparation	3 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose/start day of new anti-cancer drug therapy minus 1 day (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Concomitant medications or nondrug treatments/procedures were defined as medications or nondrug treatments/procedures, other than study intervention, which started prior to first dose date of study treatment and continued on on-treatment period as well as those started during the on-treatment period. On-treatment is defined as the time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures	5 Participants

SECONDARY outcome

Timeframe: From first dose date up to at least 28 days after last dose/start day of new anti-cancer drug therapy minus 1 day (maximum of approximately 46 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Concomitant medications or nondrug treatments/procedures were defined as medications or nondrug treatments/procedures, other than study intervention, which started prior to first dose date of study treatment and continued on on-treatment period as well as those started during the on-treatment period. On-treatment is defined as the time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT Abdominal cavity drainage	2 Participants
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT Bladder catheterisation	1 Participants
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT Endotracheal intubation	1 Participants
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT Enema administration	1 Participants
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT Enteral nutrition	1 Participants
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT Oxygen therapy	1 Participants
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT Platelet transfusion	1 Participants
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT Therapeutic procedure	1 Participants
Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT Transfusion	3 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 until disease progression, start of subsequent anti-cancer therapy or death due to any cause (maximum of approximately 45 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Tumor assessments were performed regularly during Cycles 1-12, then per local standard practice after Cycle 12. OR by investigator assessment was defined as a CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 recorded from Cycle 1 Day 1 until disease progression, start of subsequent anti-cancer therapy or death due to any cause. CR is defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. Short diameter is used in the sum for target nodes, while longest diameter is used in the sum for all other target lesions. An exact 95% confidence interval (CI) was calculated using Clopper-Pearson method. Given the exploratory nature of this endpoint, confirmation of response (CR/PR) was not required per protocol.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=15 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Percentage of Participants Achieving Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) (Confirmed or Unconfirmed)	6.7 Percentage of participants Interval 0.2 to 31.9

SECONDARY outcome

Timeframe: Cycle 1 Day 1 until disease progression, start of subsequent anti-cancer therapy or death due to any cause (maximum of approximately 45 weeks)

Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention and had an objective response (CR or PR). Number of participants analyzed = number of participant(s) evaluable for this OM.

Tumor assessments were performed regularly during Cycles 1-12 and per local standard practice after Cycle 12. Per RECIST v1.1, CR=complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). PR is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions. Short diameter is used in the sum for target nodes, while longest diameter is used in the sum for all other target lesions. For participants with an OR (CR or PR), DOR = the time from first documentation of CR or PR to date of first documentation of objective progression or death. DOR data were censored on the date of last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study. DOR was only calculated for participant(s) with an objective response. DOR was to be summarized using the Kaplan-Meier method if data permitted.

Outcome measures

Measure	Talazoparib 1 mg Once Daily (QD) n=1 Participants Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.
Duration of Response (DOR) for Participant(s) Achieving CR or PR	172 Days

Adverse Events

Talazoparib 1 mg QD

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Talazoparib 1 mg QD n=15 participants at risk Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1.
Blood and lymphatic system disorders Anaemia	13.3% 2/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Neutrophil count decreased	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Platelet count decreased	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypernatraemia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hyponatraemia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Pyrexia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Other adverse events

Measure	Talazoparib 1 mg QD n=15 participants at risk Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1.
Blood and lymphatic system disorders Anaemia	60.0% 9/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Neutropenia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Atrioventricular block first degree	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Sinus tachycardia	13.3% 2/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Ear and labyrinth disorders Vertigo	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Eye disorders Vision blurred	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal distension	13.3% 2/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain	13.3% 2/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Constipation	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Nausea	20.0% 3/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Vomiting	20.0% 3/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Fatigue	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Non-cardiac chest pain	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Pneumonia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Alanine aminotransferase increased	46.7% 7/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Aspartate aminotransferase increased	40.0% 6/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood alkaline phosphatase increased	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood bilirubin increased	20.0% 3/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood creatinine increased	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Blood lactate dehydrogenase increased	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Electrocardiogram QT prolonged	26.7% 4/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Electrocardiogram T wave abnormal	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Gamma-glutamyltransferase increased	33.3% 5/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Lymphocyte count decreased	46.7% 7/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Neutrophil count decreased	53.3% 8/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Platelet count decreased	40.0% 6/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Weight decreased	13.3% 2/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Weight increased	20.0% 3/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations White blood cell count decreased	53.3% 8/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations White blood cells urine positive	13.3% 2/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Decreased appetite	13.3% 2/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypercholesterolaemia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hyperglycaemia	20.0% 3/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypernatraemia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypertriglyceridaemia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hyperuricaemia	26.7% 4/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypoalbuminaemia	40.0% 6/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypokalaemia	26.7% 4/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hypomagnesaemia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hyponatraemia	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Nervous system disorders Dizziness	13.3% 2/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Renal and urinary disorders Haematuria	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Reproductive system and breast disorders Pelvic fluid collection	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Cough	13.3% 2/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Rash	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Embolism	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Coronary artery disease	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal discomfort	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Frequent bowel movements	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Malaise	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Urethritis	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Urinary tract infection	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Limb discomfort	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Renal and urinary disorders Hydronephrosis	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumor benign	6.7% 1/15 • From baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of 46 weeks) The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER