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CompletedNCT03070548Updated Dec 17, 2018Results posted

A Study of Talazoparib in Patients With Advanced Solid Tumors

A Phase 1 interventional study of Talazoparib in Advanced Solid Tumors, sponsored by Pfizer. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-17.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2016, registered Jan 2017).
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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..

02

Conditions studied

  • Advanced Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 6 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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]).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    ADME

    1 mg talazoparib containing100 μCi of 14C-radiolabeled talazoparib

    Drug: Talazoparib

Interventions

  • DrugTalazoparib

    1 mg of talazoparib containing100 μCi of 14C-radiolabeled talazoparib

    Also known as: MDV3800, BMN673

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Talazoparib

    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

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib

    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

  5. Terminal Elimination Half-Life (t1/2) of Talazoparib

    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

  6. Apparent Total Plasma Clearance (CL/F) of Talazoparib

    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

  7. Apparent Volume of Distribution (Vd/F) of Talazoparib

    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

  8. Maximum Observed Plasma Concentration (Cmax) of 14C- Radioactivity

    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

  9. Time to Attain Maximum Observed Plasma Concentration (Tmax) of 14C- Radioactivity

    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

  10. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity

    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

  11. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity

    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

  12. Terminal Elimination Half-Life (t1/2) of 14C- Radioactivity in Plasma

    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

  13. Apparent Total Plasma Clearance (CL/F) of 14C- Radioactivity

    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

  14. Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Plasma

    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

  15. Maximum Observed Whole Blood Concentration (Cmax) of 14C- Radioactivity

    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

  16. Time to Attain Maximum Observed Whole Blood Concentration (Tmax) of 14C- Radioactivity

    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

  17. Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity

    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

  18. Area Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity

    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

  19. Apparent Total Whole Blood Clearance (CL/F) of 14C- Radioactivity

    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

  20. Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Whole Blood

    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

  21. Amount of Talazoparib Excreted in Urine During Each Collection Interval (Ae t1-t2)

    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

  22. Percentage of Dose of Talazoparib Excreted During Each Collection Interval (Aet1-t2%) of Talazoparib

    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

  23. Renal Clearance (CLr) of Talazoparib

    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

  24. The Recovery of 14C-Radioactivity as a Percentage of the Administered 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).

    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

Secondary outcomes

  1. Ratio of Maximum Observed Plasma Concentration to Maximum Observed Whole Blood Concentration for 14C- Radioactivity

    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

  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

    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

  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

    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

  4. Number of Participants With Treatment Emergent Adverse Events (AEs)

    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)

  5. Number of Participants With Clinically Significant Vital Signs Parameters

    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

  6. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

    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

  7. Number of Participants With Clinically Significant Laboratory Abnormalities

    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

  8. Number of Participants With Change From Baseline in Physical Examination Findings

    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

  9. Amount of Any Significant Metabolites of Talazoparib in Urine and Feces

    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

07

Results

Posted Dec 17, 2018

Participant flow

Participant flow — Overall Study
MilestoneTalazoparib
Started6
Completed6
Not completed0

Outcome measures

PrimaryMaximum 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
Reported as:
Mean · nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of Talazoparib
nanogram per milliliter (ng/mL)Talazoparib
Maximum Observed Plasma Concentration (Cmax) of Talazoparib8.4 ± 3.8
PrimaryTime 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
Reported as:
Median · hours
Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib
hoursTalazoparib
Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib0.5 (0.5 to 0.5)
PrimaryArea Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Talazoparib

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
Reported as:
Mean · hour*nanogram per milliliter (hr*ng/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Talazoparib
hour*nanogram per milliliter (hr*ng/mL)Talazoparib
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Talazoparib129.9 ± 70.4
PrimaryArea Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib

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
Reported as:
Mean · hr*ng/mL
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib
hr*ng/mLTalazoparib
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib118.9 ± 65.4
PrimaryTerminal Elimination Half-Life (t1/2) of Talazoparib

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
Reported as:
Mean · hours
Terminal Elimination Half-Life (t1/2) of Talazoparib
hoursTalazoparib
Terminal Elimination Half-Life (t1/2) of Talazoparib89.8 ± 57.6
PrimaryApparent Total Plasma Clearance (CL/F) of Talazoparib

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
Reported as:
Mean · liter/hour
Apparent Total Plasma Clearance (CL/F) of Talazoparib
liter/hourTalazoparib
Apparent Total Plasma Clearance (CL/F) of Talazoparib8.39 ± 3.7
PrimaryApparent Volume of Distribution (Vd/F) of Talazoparib

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
Reported as:
Mean · liter
Apparent Volume of Distribution (Vd/F) of Talazoparib
literTalazoparib
Apparent Volume of Distribution (Vd/F) of Talazoparib922.6 ± 445.8
PrimaryMaximum Observed Plasma Concentration (Cmax) of 14C- Radioactivity

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
Reported as:
Mean · nanogram equivalent/mililiter
Maximum Observed Plasma Concentration (Cmax) of 14C- Radioactivity
nanogram equivalent/mililiterTalazoparib
Maximum Observed Plasma Concentration (Cmax) of 14C- Radioactivity12.1 ± 5.8
PrimaryTime to Attain Maximum Observed Plasma Concentration (Tmax) of 14C- Radioactivity

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
Reported as:
Median · hours
Time to Attain Maximum Observed Plasma Concentration (Tmax) of 14C- Radioactivity
hoursTalazoparib
Time to Attain Maximum Observed Plasma Concentration (Tmax) of 14C- Radioactivity0.5 (0.5 to 0.5)
PrimaryArea Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity

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
Reported as:
Mean · hour*nanogram equivalent/mililiter
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity
hour*nanogram equivalent/mililiterTalazoparib
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity222.9 ± 108.8
PrimaryArea Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity

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
Reported as:
Mean · hour*nanogram equivalent/mililiter
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity
hour*nanogram equivalent/mililiterTalazoparib
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity199.3 ± 101.9
PrimaryTerminal Elimination Half-Life (t1/2) of 14C- Radioactivity in Plasma

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
Reported as:
Mean · hours
Terminal Elimination Half-Life (t1/2) of 14C- Radioactivity in Plasma
hoursTalazoparib
Terminal Elimination Half-Life (t1/2) of 14C- Radioactivity in Plasma96.2 ± 55.1
PrimaryApparent Total Plasma Clearance (CL/F) of 14C- Radioactivity

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
Reported as:
Mean · liter/hour
Apparent Total Plasma Clearance (CL/F) of 14C- Radioactivity
liter/hourTalazoparib
Apparent Total Plasma Clearance (CL/F) of 14C- Radioactivity5.35 ± 2.35
PrimaryApparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Plasma

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
Reported as:
Mean · liter
Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Plasma
literTalazoparib
Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Plasma655.8 ± 338.1
PrimaryMaximum Observed Whole Blood Concentration (Cmax) of 14C- Radioactivity

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
Reported as:
Mean · nanogram equivalent/mililiter
Maximum Observed Whole Blood Concentration (Cmax) of 14C- Radioactivity
nanogram equivalent/mililiterTalazoparib
Maximum Observed Whole Blood Concentration (Cmax) of 14C- Radioactivity12.5 ± 5.7
PrimaryTime to Attain Maximum Observed Whole Blood Concentration (Tmax) of 14C- Radioactivity

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
Reported as:
Median · hours
Time to Attain Maximum Observed Whole Blood Concentration (Tmax) of 14C- Radioactivity
hoursTalazoparib
Time to Attain Maximum Observed Whole Blood Concentration (Tmax) of 14C- Radioactivity0.5 (0.5 to 0.5)
PrimaryArea Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity

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
Reported as:
Mean · hour*nanogram equivalent/mililiter
Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity
hour*nanogram equivalent/mililiterTalazoparib
Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity234.1 ± 114.1
PrimaryArea Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity

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
Reported as:
Mean · hour*nanogram equivalent/mililiter
Area Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity
hour*nanogram equivalent/mililiterTalazoparib
Area Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity205.8 ± 101.0
PrimaryApparent Total Whole Blood Clearance (CL/F) of 14C- Radioactivity

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
Reported as:
Mean · liter/hour
Apparent Total Whole Blood Clearance (CL/F) of 14C- Radioactivity
liter/hourTalazoparib
Apparent Total Whole Blood Clearance (CL/F) of 14C- Radioactivity5.21 ± 2.51
PrimaryApparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Whole Blood

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
Reported as:
Mean · liter
Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Whole Blood
literTalazoparib
Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Whole Blood484.4 ± 237.5
PrimaryAmount of Talazoparib Excreted in Urine During Each Collection Interval (Ae t1-t2)

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
Reported as:
Mean · micrograms
Amount of Talazoparib Excreted in Urine During Each Collection Interval (Ae t1-t2)
microgramsTalazoparib
Amount of Talazoparib Excreted in Urine During Each Collection Interval (Ae t1-t2)366.07 ± 45.56
PrimaryPercentage of Dose of Talazoparib Excreted During Each Collection Interval (Aet1-t2%) of Talazoparib

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
Reported as:
Mean · percentage of dose
Percentage of Dose of Talazoparib Excreted During Each Collection Interval (Aet1-t2%) of Talazoparib
percentage of doseTalazoparib
Percentage of Dose of Talazoparib Excreted During Each Collection Interval (Aet1-t2%) of Talazoparib40.92 ± 4.324
PrimaryRenal Clearance (CLr) of Talazoparib

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
Reported as:
Mean · liter/hour
Renal Clearance (CLr) of Talazoparib
liter/hourTalazoparib
Renal Clearance (CLr) of Talazoparib3.808 ± 1.979
PrimaryThe Recovery of 14C-Radioactivity as a Percentage of the Administered 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).

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
Reported as:
Mean · Percentage of dose
The Recovery of 14C-Radioactivity as a Percentage of the Administered Dose
Percentage of doseTalazoparib
Urine68.647 ± 8.592
Feces19.669 ± 5.493
SecondaryRatio of Maximum Observed Plasma Concentration to Maximum Observed Whole Blood Concentration for 14C- Radioactivity

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
Reported as:
Mean · ratio
Ratio of Maximum Observed Plasma Concentration to Maximum Observed Whole Blood Concentration for 14C- Radioactivity
ratioTalazoparib
Ratio of Maximum Observed Plasma Concentration to Maximum Observed Whole Blood Concentration for 14C- Radioactivity1.050 ± 0.0625
SecondaryRatio 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

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
Reported as:
Mean · ratio
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
ratioTalazoparib
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- Radioactivity1.047 ± 0.1155
SecondaryRatio 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

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
Reported as:
Mean · ratio
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
ratioTalazoparib
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- Radioactivity1.037 ± 0.1243
SecondaryNumber of Participants With Treatment Emergent Adverse Events (AEs)

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)
Reported as:
Number · participants
Number of Participants With Treatment Emergent Adverse Events (AEs)
participantsTalazoparib
Number of Participants With Treatment Emergent Adverse Events (AEs)4
SecondaryNumber of Participants With Clinically Significant Vital Signs Parameters

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
Reported as:
Number · participants
Number of Participants With Clinically Significant Vital Signs Parameters
participantsTalazoparib
Number of Participants With Clinically Significant Vital Signs Parameters0
SecondaryNumber of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

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
Reported as:
Number · participants
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
participantsTalazoparib
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities0
SecondaryNumber of Participants With Clinically Significant Laboratory Abnormalities

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
Reported as:
Number · participants
Number of Participants With Clinically Significant Laboratory Abnormalities
participantsTalazoparib
Number of Participants With Clinically Significant Laboratory Abnormalities0
SecondaryNumber of Participants With Change From Baseline in Physical Examination Findings

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
Reported as:
Number · participants
Number of Participants With Change From Baseline in Physical Examination Findings
participantsTalazoparib
Number of Participants With Change From Baseline in Physical Examination Findings0
SecondaryAmount of Any Significant Metabolites of Talazoparib in Urine and Feces

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
Reported as:
Number · percentage of dose
Amount of Any Significant Metabolites of Talazoparib in Urine and Feces
percentage of doseTalazoparib
M481/1: Urine4.2
MDV10595+M556/1+M396/1: Urine0.8
MDV10595+M556/1+M396/1: Feces1.5

Adverse events

Collected over 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). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Talazoparib0/6 (0%)0/6 (0%)4/6 (66.7%)
Most frequent other events
Most frequent other events
EventTalazoparib
DizzinessNervous system disorders2/6
ConstipationGastrointestinal disorders1/6
Musculoskeletal painMusculoskeletal and connective tissue disorders1/6
Pain in extremityMusculoskeletal and connective tissue disorders1/6
ParaesthesiaNervous system disorders1/6
PollakiuriaRenal and urinary disorders1/6

Baseline characteristics

Safety analysis set included all participants who had received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)Talazoparib
Mean50.2 ± 17.61
Sex: Female, Male
Sex: Female, Male(Participants)Talazoparib
Female6
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Talazoparib
Hispanic or Latino0
Not Hispanic or Latino6
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Talazoparib
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White6
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • PRA Magyarorszag Kft, Fazis I-es Klinikai Farmakologiai Vizsgalohely
    Budapest, 1077, Hungary
09

References and documents

Study documents

  • Study protocol · Oct 7, 2016
  • Statistical analysis plan · Jul 16, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03070548
Lead sponsor
Pfizer
Collaborators
Medivation, Inc.
Responsible party
Sponsor
First posted
Mar 3, 2017
Start date
Sep 2016
Primary completion
Jun 2017
Completion
Jun 2017
Results posted
Dec 17, 2018
Last update
Dec 17, 2018

Study contacts

Pfizer Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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