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An Open-Label Pharmacokinetics and Safety Study of Talazoparib

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Intertek USA, Inc.
San Diego, California, 92121 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Signed and dated informed consent form (by the patient or a legally acceptable
representative as per the local regulations) obtained prior to initiation of any
study-specific procedure and treatment.

2. Female or male of at least 18 years of age.

3. Histologically or cytologically confirmed advanced solid tumor with no available
standard approved treatment options in the opinion of the Investigator

4. Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 2.

5. Expected life expectancy of ≥ 3 months.

6. Able to swallow the study drug (no contra indication to oral agents).

7. Renal function at screening and enrollment as defined by the Modification of Diet in
Renal Disease (MDRD) equation.

8. Patient has had no clinically significant change in renal status within 3 months prior
to screening, according to Investigator's review of clinical patient records.

9. Patient is not currently on hemodialysis and/or peritoneal dialysis for management of
chronic kidney disease or acute failure/conditions.

10. Patient has no unstable renal function, defined as a change in estimated glomerular
filtration rate (eGFR) (calculated with the MDRD equation) of > 25% for patients with
mild and moderate renal impaired or as a change in eGFR > 30% for patients with severe
renal impaired, from screening to enrollment.

11. Adequate other organ function at screening and enrollment.

12. Female patients of childbearing potential must have a negative serum pregnancy test at
screening, and must agree to use a highly effective birth control method from the time
of the first dose of study drug through 45 days after the last dose of study drug.

13. Male patients must agree to use a condom when having sex with a pregnant woman or with
a non-pregnant female partner of childbearing potential, from 21 days before the first
dose of study drug through 105 days after last dose of study drug.

14. Female patients must not be breastfeeding at screening nor during the study
participation until 45 days after the last dose of study drug.

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Treatment within 14 days or five half lives prior to enrollment with any type of
systemic anticancer-therapy or any investigational drug, whichever is longer.

2. Have not recovered (recovery is defined as CTCAE grade ? 1) from the acute toxicities
of previous anticancer standard or investigational therapy, except treatment-related
alopecia or laboratory abnormalities otherwise meeting eligibility requirements.

3. Major surgery within 28 days prior to enrollment.

4. Serious accompanying cardiac disorder.

5. Active known or suspected brain metastasis or active leptomeningeal disease undergoing
or requiring treatment.

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

7. Has undergone a liver transplant, kidney transplant or nephrectomy.

8. Prior allergic reaction or severe intolerance (meeting the criteria for a serious
adverse event, a grade 3 or 4 AE, or permanent treatment discontinuation) to a poly
ADP ribose polymerase (PARP) inhibitor.

9. Known myelodysplastic syndrome.

10. Seropositive for human immunodeficiency virus (HIV).

11. Any serious or unstable medical condition that interferes with ability to tolerate
treatment or assessments associated with the protocol.

12. Gastrointestinal disorder affecting absorption.

13. Known or suspected hypersensitivity to any of the talazoparib capsule components.

14. Any condition or reason that interferes with ability to participate in the study,
tolerate treatment or assessments associated with the protocol, causes undue risk, or
complicates the interpretation of safety data, in the opinion of the Investigator or
Medical Monitor.

NCT02997163
Pfizer
Recruiting
An Open-Label Pharmacokinetics and Safety Study of Talazoparib

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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