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A Study of Talazoparib in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070548
Recruitment Status : Completed
First Posted : March 3, 2017
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Solid Tumors
Intervention Drug: Talazoparib
Enrollment 6
Recruitment Details  
Pre-assignment Details 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
Hide 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
Arm/Group Title Talazoparib
Hide 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 Number of Baseline Participants 6
Hide Baseline Analysis Population Description
Safety analysis set included all participants who had received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
50.2  (17.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
6
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
6
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
8.4  (3.8)
2.Primary Outcome
Title Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
0.5
(0.5 to 0.5)
3.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Talazoparib
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
118.9  (65.4)
5.Primary Outcome
Title Terminal Elimination Half-Life (t1/2) of Talazoparib
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hours
89.8  (57.6)
6.Primary Outcome
Title Apparent Total Plasma Clearance (CL/F) of Talazoparib
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: liter/hour
8.39  (3.7)
7.Primary Outcome
Title Apparent Volume of Distribution (Vd/F) of Talazoparib
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: liter
922.6  (445.8)
8.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of 14C- Radioactivity
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: nanogram equivalent/mililiter
12.1  (5.8)
9.Primary Outcome
Title Time to Attain Maximum Observed Plasma Concentration (Tmax) of 14C- Radioactivity
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
0.5
(0.5 to 0.5)
10.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hour*nanogram equivalent/mililiter
199.3  (101.9)
12.Primary Outcome
Title Terminal Elimination Half-Life (t1/2) of 14C- Radioactivity in Plasma
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hours
96.2  (55.1)
13.Primary Outcome
Title Apparent Total Plasma Clearance (CL/F) of 14C- Radioactivity
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: liter/hour
5.35  (2.35)
14.Primary Outcome
Title Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Plasma
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: liter
655.8  (338.1)
15.Primary Outcome
Title Maximum Observed Whole Blood Concentration (Cmax) of 14C- Radioactivity
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: nanogram equivalent/mililiter
12.5  (5.7)
16.Primary Outcome
Title Time to Attain Maximum Observed Whole Blood Concentration (Tmax) of 14C- Radioactivity
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hours
0.5
(0.5 to 0.5)
17.Primary Outcome
Title Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hour*nanogram equivalent/mililiter
205.8  (101.0)
19.Primary Outcome
Title Apparent Total Whole Blood Clearance (CL/F) of 14C- Radioactivity
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: liter/hour
5.21  (2.51)
20.Primary Outcome
Title Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Whole Blood
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: liter
484.4  (237.5)
21.Primary Outcome
Title Amount of Talazoparib Excreted in Urine During Each Collection Interval (Ae t1-t2)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: micrograms
366.07  (45.56)
22.Primary Outcome
Title Percentage of Dose of Talazoparib Excreted During Each Collection Interval (Aet1-t2%) of Talazoparib
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percentage of dose
40.92  (4.324)
23.Primary Outcome
Title Renal Clearance (CLr) of Talazoparib
Hide 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
Hide Outcome Measure Data
Hide 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
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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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: liter/hour
3.808  (1.979)
24.Primary Outcome
Title The Recovery of 14C-Radioactivity as a Percentage of the Administered Dose
Hide 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
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PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.
Arm/Group Title Talazoparib
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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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: Percentage of dose
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
Hide 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
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PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.
Arm/Group Title Talazoparib
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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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
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PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.
Arm/Group Title Talazoparib
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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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
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PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.
Arm/Group Title Talazoparib
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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 Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ratio
1.037  (0.1243)
28.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs)
Hide 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)
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Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib
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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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
4
29.Secondary Outcome
Title Number of Participants With Clinically Significant Vital Signs Parameters
Hide 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
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Safety analysis set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib
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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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
0
30.Secondary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Hide 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
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Safety population set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib
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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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
0
31.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities
Hide 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
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Safety population set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib
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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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
0
32.Secondary Outcome
Title Number of Participants With Change From Baseline in Physical Examination Findings
Hide 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
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Hide Analysis Population Description
Safety population set included all participants who received at least 1 dose of talazoparib.
Arm/Group Title Talazoparib
Hide 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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
0
33.Secondary Outcome
Title Amount of Any Significant Metabolites of Talazoparib in Urine and Feces
Hide 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
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PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.
Arm/Group Title Talazoparib
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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 Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of dose
M481/1: Urine 4.2
MDV10595+M556/1+M396/1: Urine 0.8
MDV10595+M556/1+M396/1: Feces 1.5
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
Hide 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 (%)
Total   0/6 (0.00%) 
Hide Serious Adverse Events
Talazoparib
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Talazoparib
Affected / at Risk (%)
Total   4/6 (66.67%) 
Gastrointestinal disorders   
Constipation * 1  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain * 1  1/6 (16.67%) 
Pain in extremity * 1  1/6 (16.67%) 
Nervous system disorders   
Paraesthesia * 1  1/6 (16.67%) 
Dizziness * 1  2/6 (33.33%) 
Renal and urinary disorders   
Pollakiuria * 1  1/6 (16.67%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03070548    
Other Study ID Numbers: MDV3800-03
C3441003 ( Other Identifier: Alias Study Number )
2016-001394-33 ( EudraCT Number )
First Submitted: January 24, 2017
First Posted: March 3, 2017
Results First Submitted: May 25, 2018
Results First Posted: December 17, 2018
Last Update Posted: December 17, 2018