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Open-Label Extension and Safety Study of Talazoparib

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cancer
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.
Show details

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

- Female patients of childbearing potential must have a negative pregnancy test before
the first dose of talazoparib and must agree to use a highly effective birth control
method from the time of the first dose of talazoparib through 45 days after the last
dose.

- Male patients must use a condom when having sex with a pregnant woman or with a woman
of childbearing potential from the time of the first dose of talazoparib through 105
days after the last dose. Contraception should be considered for a nonpregnant female
partner of childbearing potential.

- Female patients may not be breastfeeding at the first dose of talazoparib and must not
breastfeed during study participation through 45 days after the last dose of
talazoparib.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Permanently discontinued from any Medivation sponsored study with talazoparib alone or
in combination with another agent.

- Received an antineoplastic therapy or investigational agent after treatment with
talazoparib in the originating protocol.

- Has a clinically significant cardiovascular, dermatologic, endocrine,
gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or
pulmonary disorder or any other condition, including excessive alcohol or drug abuse,
or secondary malignancy, that may interfere with study participation in the opinion of
the investigator.

- Diagnosis of myelodysplastic syndrome (MDS).

NCT02921919
Pfizer
Recruiting
Open-Label Extension and Safety Study of Talazoparib

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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]

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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]

Call Now