A Study of Talazoparib in Patients With Advanced Solid Tumors

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03070548
• Collaborator: Medivation, Inc. (Industry)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study will evaluate the mass balance of talazoparib after a single dose of talazoparib.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: Talazoparib	Phase 1

Detailed Description

Patients participating in this study with no clinically significant toxicities may be eligible to continue treatment on a separate extension protocol after discussion with the Principal Investigator and obtaining Sponsor permission..

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Open-label Study Of 14c-labeled Talazoparib In Patients With Advanced Solid Tumors
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ADME 1 mg talazoparib containing100 μCi of 14C-radiolabeled talazoparib	Drug: Talazoparib; 1 mg of talazoparib containing100 μCi of 14C-radiolabeled talazoparib; Other Names: MDV3800 BMN673

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of Talazoparib [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

2. Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Talazoparib [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf).

4. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration.

5. Terminal Elimination Half-Life (t1/2) of Talazoparib [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half.

6. Apparent Total Plasma Clearance (CL/F) of Talazoparib [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   Clearance of a drug was measure of the rate at which a drug was metabolized or eliminated by normal biological processes.

7. Apparent Volume of Distribution (Vd/F) of Talazoparib [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of the drug.

8. Maximum Observed Plasma Concentration (Cmax) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

9. Time to Attain Maximum Observed Plasma Concentration (Tmax) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

10. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

11. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

12. Terminal Elimination Half-Life (t1/2) of 14C- Radioactivity in Plasma [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    Terminal elimination half-life was defined as the time measured for the plasma radioactivity concentration to decrease by one half. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

13. Apparent Total Plasma Clearance (CL/F) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

14. Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Plasma [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

15. Maximum Observed Whole Blood Concentration (Cmax) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

16. Time to Attain Maximum Observed Whole Blood Concentration (Tmax) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

17. Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

18. Area Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

19. Apparent Total Whole Blood Clearance (CL/F) of 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

20. Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Whole Blood [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

    Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of the drug. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

21. Amount of Talazoparib Excreted in Urine During Each Collection Interval (Ae t1-t2) [Pre-dose, 0 to 8 hours (hrs), 8 to 24 hrs, 24 to 48 hrs, 48 to 72 hrs, 72 to 96 hrs and then after every 24 hrs until up to 504 hrs post-dose]

    Ae t1-t2 was defined as the amount of talazoparib excreted into urine during each collection interval (t1-t2).

22. Percentage of Dose of Talazoparib Excreted During Each Collection Interval (Aet1-t2%) of Talazoparib [Pre-dose, 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs, 48 to 72 hrs, 72 to 96 hrs and then after every 24 hrs until up to 504 hrs post-dose]

    Aet1-t2% was the percentage of Aet1-t2, where Aet1-t2 was defined as the amount of talazoparib excreted into urine during each collection interval (t1-t2).

23. Renal Clearance (CLr) of Talazoparib [Pre-dose, 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs, 48 to 72 hrs, 72 to 96 hrs and then after every 24 hrs until up to 504 hrs post-dose]

    Renal clearance was calculated as cumulative amount of drug excreted in urine divided by AUC(0-last) (area under the plasma concentration-time curve from zero to the time of the last measurable concentration).

24. The Recovery of 14C-Radioactivity as a Percentage of the Administered Dose [From 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs and then after every 24 hrs until up to 504 hrs post-dose]

    Recovery of 14C-radioactivity in urine and feces was calculated in terms of percentage of administered dose after administration of a single 1 mg dose of oral solution (containing 100 micro-curie 14C-labeled talazoparib).

Secondary Outcome Measures

1. Ratio of Maximum Observed Plasma Concentration to Maximum Observed Whole Blood Concentration for 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   100 micro-curie of 14C radiolabeled talazoparib was present in 1 mg of talazoparib.

2. Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity to Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity for 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

3. Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration to Area Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable for 14C- Radioactivity [Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose]

   AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.

4. Number of Participants With Treatment Emergent Adverse Events (AEs) [Day 1 to 14 days after last day of mass balance phase and at least 30 days after Day1/before initiation of new cytotoxic chemotherapy, new investigational treatment/first day of extension protocol, whichever occurs first(up to maximum duration of 8 weeks)]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug through 14 days after the last day of mass balance phase and at least 30 days after Day 1 or before initiation of new cytotoxic chemotherapy, new investigational treatment, or the first day of extension protocol, whichever occurs first (up to maximum duration of 8 weeks from screening to follow-up for each participant) or before initiation of new cytotoxic chemotherapy, new investigational treatment, or the first day of extension protocol, whichever occurs first, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs).

5. Number of Participants With Clinically Significant Vital Signs Parameters [Baseline up to Day 22]

   Vital Signs included heart rate, respiratory rate, body temperature, systolic blood pressure and diastolic blood pressure. clinical significance of vital signs was determined at the investigator's discretion.

6. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [Baseline up to Day 22]

   Criteria for clinically significant ECG abnormalities : Heart Rate; increase from baseline greater than (>)25 %and to a value >100, decrease from baseline >25% and to a value < 50; PR Interval: increase from baseline >25% and to a value >200; QRS Duration: increase from baseline >25% and to a value >100; QT interval using Fridericia's correction (QTcF): ranges >450 msec, >480 msec, >500 msec, Increase from baseline >30 msec and >60 msec; QT Interval: ranges >450 msec, >480 msec, >500 msec, Increase from baseline >30 msec and >60 msec.

7. Number of Participants With Clinically Significant Laboratory Abnormalities [Baseline up to Day 22]

   Haematological, biochemistry and urinalysis parameters. Biochemistry parameters:alkaline phosphatase 30-120units per liter(U/L), creatinine 53-110micromole/L(micromol/L), gamma glutamyl transferase 7-50U/L, glucose 3.3-5.5millimoles/L(mmol/L), lactate dehydrogenase 200-460U/L, triglycerides 0.4-1.7mmol/L, cholesterol 2.6-5.2mmol/L, phosphate 0.8-1.45mmol/L, sodium 135-146mmol/L, urea 2.8-7.2mmol/L, chloride 95-109mmol/L, creatine kinase 24-170U/L, aspartate aminotransferase 4-46U/L, potassium 3.5-5.5mmol/L. Haematology parameters:haemoglobin 120-155 gram/L(g/L), erythrocytes 4-5.2 10^12/L, haematocrit 0.35-0.45, prothrombin time 13.7-15.6 second(sec), lymphocytes 1-3.7 10^9/L, platelets 150-400 10^9/L, prothrombin intl. normalized ratio 0.89-1.1, activated partial thromboplastin time 25-43 sec, basophils 0-0.09 10^9/L, neutrophils 1.5-7 10^9/L, and leukocytes 4-10 10^9/L. Urinalysis parameters:urinalysis specific gravity 1.012-1.03, urinalysis pH 4.8-7.8.

8. Number of Participants With Change From Baseline in Physical Examination Findings [Baseline up to Day 22]

   Physical examination included examination of abdomen, cardiovascular, eyes, ears, nose, throat, general appearance, head, neck, thyroid, lymph nodes, musculoskeletal, neurological, skin/subcutaneous tissue and thorax/lungs.

9. Amount of Any Significant Metabolites of Talazoparib in Urine and Feces [From 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs and then after every 24 hrs until up to 504 hrs post-dose]

   M4 (M481/1, cysteine conjugate of mono-desfluoro-talazoparib) metabolite was found in urine. MDV10595 (M1, dehydrogenated talazoparib (PF-07052386), M556/1 (glucuronide conjugate of talazoparib), and M2 (M396/1, mono-oxidative talazoparib) metabolites were calculated together and were also found in urine. Three metabolites named as: MDV10595 (M1)/M556/1 and M2 (M396/1) which were calculated together were detected in feces. Amount of metabolite in this outcome measure was measured in terms of percentage of dose of talazoparib.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. At least 18 years of age and willing and able to provide informed consent.

2. Histologically confirmed advanced solid tumor (limited to platinum-resistant ovarian carcinoma, cervical adenocarcinoma, small cell lung carcinoma or triple-negative breast cancer) judged by the Investigator to not be appropriate for standard therapy.

3. Eastern Co-Operative Oncology Group (ECOG) performance status ≤ 2 at screening and Day -1.

4. Expected life expectancy of ≥ 3 months.

5. Able to swallow the study drug and comply with study requirements.

6. Female subjects may be enrolled if they are considered not of childbearing potential, or who are post-menopausal, or of childbearing potential using a highly effective form of contraception, and female subjects should not donate eggs from the time point of IMP administration until at least 45 days thereafter.

7. Males with partners of childbearing potential may be enrolled if they use a condom when having sex with a pregnant woman or with a woman of childbearing potential from 21 days before the first dose of study drug through 105 days after the last dose of study drug, and males should not donate sperm from the time point of study drug administration until at least 105 days thereafter.

8. Female patients must not be breastfeeding at screening and during the study participation until 45 days after the last dose of the study drug.

9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

1. Treatment within 14 weeks or five half-live prior to dosing with any type of systemic anticancer therapy or any investigational agent, whichever is longer.

2. Major surgery within 8 weeks before screening.

3. Serious accompanying disorder or impaired organ function.

4. Symptomatic or impending spinal cord compression or cauda equina syndrome.

5. Non-healing wound, ulcer, or bone fracture, not including a pathological bone fracture caused by a pre-existent pathological bone lesion.

6. Known myelodysplastic syndrome.

7. Patients with the following serologies should be excluded: HBsAg+ or anti-HBc+; HCV+; HIV+.

8. Serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.

9. Gastrointestinal disorder affecting absorption.

10. Known hypersensitivity to any of the talazoparib solution components.

11. Use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BRCP within 7 days or 5 half-lives, whichever is longer, before Day 1.

12. Any condition or reason that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Sponsor (e.g. non-compliance, excessive alcohol consumption, intake of drugs of abuse unless these drugs are medically indicated [e.g. opiates for pain relief]).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Magyarorszag Kft, Fazis I-es Klinikai Farmakologiai Vizsgalohely	Budapest		Hungary	1077

Sponsors and Collaborators

• Pfizer
• Medivation, Inc.

Investigators

• Study Director: Pfizer Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Oct 7, 2016
• Statistical Analysis Plan - Jul 16, 2017

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03070548
• Other Study ID Numbers: MDV3800-03; C3441003; 2016-001394-33
• First Posted: Mar 3, 2017
• Last Update Posted: Dec 17, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Neoplasms; Talazoparib

Study Results

Participant Flow

Pre-assignment Detail	This is a mass balance study with 14C-radiolabeled talazoparib in at least 6 participants with advanced solid tumors who qualified for treatment with talazoparib. Participants who completed the mass-balance part in this study had the option to continue treatment on an open-label extension protocol.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 miligram (mg) oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Overall Participants	6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.2 (17.61)
Sex: Female, Male (Count of Participants)
Female	6 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	6 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 100%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [nanogram per milliliter (ng/mL)]	8.4 (3.8)

2. Primary Outcome

Title	Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Median (Full Range) [hours]	0.5

3. Primary Outcome

Title	Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Talazoparib
Description	AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf).
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [hour*nanogram per milliliter (hr*ng/mL)]	129.9 (70.4)

4. Primary Outcome

Title	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib
Description	AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [hr*ng/mL]	118.9 (65.4)

5. Primary Outcome

Title	Terminal Elimination Half-Life (t1/2) of Talazoparib
Description	Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [hours]	89.8 (57.6)

6. Primary Outcome

Title	Apparent Total Plasma Clearance (CL/F) of Talazoparib
Description	Clearance of a drug was measure of the rate at which a drug was metabolized or eliminated by normal biological processes.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [liter/hour]	8.39 (3.7)

7. Primary Outcome

Title	Apparent Volume of Distribution (Vd/F) of Talazoparib
Description	Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of the drug.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [liter]	922.6 (445.8)

8. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of 14C- Radioactivity
Description	100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [nanogram equivalent/mililiter]	12.1 (5.8)

9. Primary Outcome

Title	Time to Attain Maximum Observed Plasma Concentration (Tmax) of 14C- Radioactivity
Description	100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Median (Full Range) [hours]	0.5

10. Primary Outcome

Title	Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity
Description	AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [hour*nanogram equivalent/mililiter]	222.9 (108.8)

11. Primary Outcome

Title	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity
Description	AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [hour*nanogram equivalent/mililiter]	199.3 (101.9)

12. Primary Outcome

Title	Terminal Elimination Half-Life (t1/2) of 14C- Radioactivity in Plasma
Description	Terminal elimination half-life was defined as the time measured for the plasma radioactivity concentration to decrease by one half. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [hours]	96.2 (55.1)

13. Primary Outcome

Title	Apparent Total Plasma Clearance (CL/F) of 14C- Radioactivity
Description	Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [liter/hour]	5.35 (2.35)

14. Primary Outcome

Title	Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Plasma
Description	Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [liter]	655.8 (338.1)

15. Primary Outcome

Title	Maximum Observed Whole Blood Concentration (Cmax) of 14C- Radioactivity
Description	100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [nanogram equivalent/mililiter]	12.5 (5.7)

16. Primary Outcome

Title	Time to Attain Maximum Observed Whole Blood Concentration (Tmax) of 14C- Radioactivity
Description	100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Median (Full Range) [hours]	0.5

17. Primary Outcome

Title	Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity
Description	AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [hour*nanogram equivalent/mililiter]	234.1 (114.1)

18. Primary Outcome

Title	Area Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity
Description	AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [hour*nanogram equivalent/mililiter]	205.8 (101.0)

19. Primary Outcome

Title	Apparent Total Whole Blood Clearance (CL/F) of 14C- Radioactivity
Description	Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [liter/hour]	5.21 (2.51)

20. Primary Outcome

Title	Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Whole Blood
Description	Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of the drug. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [liter]	484.4 (237.5)

21. Primary Outcome

Title	Amount of Talazoparib Excreted in Urine During Each Collection Interval (Ae t1-t2)
Description	Ae t1-t2 was defined as the amount of talazoparib excreted into urine during each collection interval (t1-t2).
Time Frame	Pre-dose, 0 to 8 hours (hrs), 8 to 24 hrs, 24 to 48 hrs, 48 to 72 hrs, 72 to 96 hrs and then after every 24 hrs until up to 504 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [micrograms]	366.07 (45.56)

22. Primary Outcome

Title	Percentage of Dose of Talazoparib Excreted During Each Collection Interval (Aet1-t2%) of Talazoparib
Description	Aet1-t2% was the percentage of Aet1-t2, where Aet1-t2 was defined as the amount of talazoparib excreted into urine during each collection interval (t1-t2).
Time Frame	Pre-dose, 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs, 48 to 72 hrs, 72 to 96 hrs and then after every 24 hrs until up to 504 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [percentage of dose]	40.92 (4.324)

23. Primary Outcome

Title	Renal Clearance (CLr) of Talazoparib
Description	Renal clearance was calculated as cumulative amount of drug excreted in urine divided by AUC(0-last) (area under the plasma concentration-time curve from zero to the time of the last measurable concentration).
Time Frame	Pre-dose, 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs, 48 to 72 hrs, 72 to 96 hrs and then after every 24 hrs until up to 504 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [liter/hour]	3.808 (1.979)

24. Primary Outcome

Title	The Recovery of 14C-Radioactivity as a Percentage of the Administered Dose
Description	Recovery of 14C-radioactivity in urine and feces was calculated in terms of percentage of administered dose after administration of a single 1 mg dose of oral solution (containing 100 micro-curie 14C-labeled talazoparib).
Time Frame	From 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs and then after every 24 hrs until up to 504 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Urine	68.647 (8.592)
Feces	19.669 (5.493)

25. Secondary Outcome

Title	Ratio of Maximum Observed Plasma Concentration to Maximum Observed Whole Blood Concentration for 14C- Radioactivity
Description	100 micro-curie of 14C radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [ratio]	1.050 (0.0625)

26. Secondary Outcome

Title	Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity to Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity for 14C- Radioactivity
Description	AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [ratio]	1.047 (0.1155)

27. Secondary Outcome

Title	Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration to Area Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable for 14C- Radioactivity
Description	AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.
Time Frame	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Mean (Standard Deviation) [ratio]	1.037 (0.1243)

28. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug through 14 days after the last day of mass balance phase and at least 30 days after Day 1 or before initiation of new cytotoxic chemotherapy, new investigational treatment, or the first day of extension protocol, whichever occurs first (up to maximum duration of 8 weeks from screening to follow-up for each participant) or before initiation of new cytotoxic chemotherapy, new investigational treatment, or the first day of extension protocol, whichever occurs first, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs).
Time Frame	Day 1 to 14 days after last day of mass balance phase and at least 30 days after Day1/before initiation of new cytotoxic chemotherapy, new investigational treatment/first day of extension protocol, whichever occurs first(up to maximum duration of 8 weeks)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of talazoparib.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Number [participants]	4 66.7%

29. Secondary Outcome

Title	Number of Participants With Clinically Significant Vital Signs Parameters
Description	Vital Signs included heart rate, respiratory rate, body temperature, systolic blood pressure and diastolic blood pressure. clinical significance of vital signs was determined at the investigator's discretion.
Time Frame	Baseline up to Day 22

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of talazoparib.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Number [participants]	0 0%

30. Secondary Outcome

Title	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description	Criteria for clinically significant ECG abnormalities : Heart Rate; increase from baseline greater than (>)25 %and to a value >100, decrease from baseline >25% and to a value < 50; PR Interval: increase from baseline >25% and to a value >200; QRS Duration: increase from baseline >25% and to a value >100; QT interval using Fridericia's correction (QTcF): ranges >450 msec, >480 msec, >500 msec, Increase from baseline >30 msec and >60 msec; QT Interval: ranges >450 msec, >480 msec, >500 msec, Increase from baseline >30 msec and >60 msec.
Time Frame	Baseline up to Day 22

Outcome Measure Data

Analysis Population Description

Safety population set included all participants who received at least 1 dose of talazoparib.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Number [participants]	0 0%

31. Secondary Outcome

Title	Number of Participants With Clinically Significant Laboratory Abnormalities
Description	Haematological, biochemistry and urinalysis parameters. Biochemistry parameters:alkaline phosphatase 30-120units per liter(U/L), creatinine 53-110micromole/L(micromol/L), gamma glutamyl transferase 7-50U/L, glucose 3.3-5.5millimoles/L(mmol/L), lactate dehydrogenase 200-460U/L, triglycerides 0.4-1.7mmol/L, cholesterol 2.6-5.2mmol/L, phosphate 0.8-1.45mmol/L, sodium 135-146mmol/L, urea 2.8-7.2mmol/L, chloride 95-109mmol/L, creatine kinase 24-170U/L, aspartate aminotransferase 4-46U/L, potassium 3.5-5.5mmol/L. Haematology parameters:haemoglobin 120-155 gram/L(g/L), erythrocytes 4-5.2 10^12/L, haematocrit 0.35-0.45, prothrombin time 13.7-15.6 second(sec), lymphocytes 1-3.7 10^9/L, platelets 150-400 10^9/L, prothrombin intl. normalized ratio 0.89-1.1, activated partial thromboplastin time 25-43 sec, basophils 0-0.09 10^9/L, neutrophils 1.5-7 10^9/L, and leukocytes 4-10 10^9/L. Urinalysis parameters:urinalysis specific gravity 1.012-1.03, urinalysis pH 4.8-7.8.
Time Frame	Baseline up to Day 22

Outcome Measure Data

Analysis Population Description

Safety population set included all participants who received at least 1 dose of talazoparib.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Number [participants]	0 0%

32. Secondary Outcome

Title	Number of Participants With Change From Baseline in Physical Examination Findings
Description	Physical examination included examination of abdomen, cardiovascular, eyes, ears, nose, throat, general appearance, head, neck, thyroid, lymph nodes, musculoskeletal, neurological, skin/subcutaneous tissue and thorax/lungs.
Time Frame	Baseline up to Day 22

Outcome Measure Data

Analysis Population Description

Safety population set included all participants who received at least 1 dose of talazoparib.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
Number [participants]	0 0%

33. Secondary Outcome

Title	Amount of Any Significant Metabolites of Talazoparib in Urine and Feces
Description	M4 (M481/1, cysteine conjugate of mono-desfluoro-talazoparib) metabolite was found in urine. MDV10595 (M1, dehydrogenated talazoparib (PF-07052386), M556/1 (glucuronide conjugate of talazoparib), and M2 (M396/1, mono-oxidative talazoparib) metabolites were calculated together and were also found in urine. Three metabolites named as: MDV10595 (M1)/M556/1 and M2 (M396/1) which were calculated together were detected in feces. Amount of metabolite in this outcome measure was measured in terms of percentage of dose of talazoparib.
Time Frame	From 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs and then after every 24 hrs until up to 504 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.

Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
Measure Participants	6
M481/1: Urine	4.2
MDV10595+M556/1+M396/1: Urine	0.8
MDV10595+M556/1+M396/1: Feces	1.5

Adverse Events

Time Frame	Day1 up to 14days after last day of mass balance phase and at least 30days after Day1/ before initiation of new cytotoxic chemotherapy, new investigational treatment/ first day of extension protocol, whichever occurs first (up to maximum duration of 8weeks from screening to follow-up for each participant)
Adverse Event Reporting Description	Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who had received at least 1 dose of study drug.
Arm/Group Title	Talazoparib
Arm/Group Description	Participants with advanced solid tumors received a single dose of talazoparib 1 mg oral solution (containing approximately 100 micro Curie of 14C-talazoparib) on Day 1. Participants were followed-up within 14 days after the last day of mass balance phase and at least 30 days after Day 1 or the first day of extension protocol, whichever occurred first (up to maximum duration of 8 weeks from screening to follow-up for each participant).
All Cause Mortality
	Talazoparib
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	Talazoparib
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Talazoparib
	Affected / at Risk (%)	# Events
Total	4/6 (66.7%)
Gastrointestinal disorders
Constipation	1/6 (16.7%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	1/6 (16.7%)
Pain in extremity	1/6 (16.7%)
Nervous system disorders
Paraesthesia	1/6 (16.7%)
Dizziness	2/6 (33.3%)
Renal and urinary disorders
Pollakiuria	1/6 (16.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.