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A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors

Last updated on February 23, 2019

FOR MORE INFORMATION
Study Location
PRA Magyarorszag Kft, Fazis I-es Klinikai Farmakologiai Vizsgalohely
Budapest, , 1077 Hungary
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. Arm A: At least 18 years of age and and willing and able to provide informed consent. Arm B: At least 18 years of age (at
the time point of consent) 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. ECOG performance status ≤ 2 at screening and at time of enrollment.

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 are of childbearing potential using a highly effective
form of contraceptive, and female subjects should not donate eggs from the time point
of investigational medicinal product (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, and
do not donate sperm from the time point of study drug administration until at least
105 days thereafter, and males should not donate sperm from the time point of study
drug administration until at least 105 days thereafter.

8. Female subjects 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Treatment within 14 days or 5 half lives 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. Subjects 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 capsule components.

11. 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].

NCT03077607
Pfizer
Completed
A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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