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Open-Label Extension and Safety Study of Talazoparib

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
UCLA Hematology/Oncology - Alhambra
Alhambra, California, 91801 United States
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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Open-Label Extension and Safety Study of Talazoparib
A Single-arm, Open-label, Multicenter, Extended Treatment, Safety Study In Patients Treated With Talazoparib
This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.
Not Provided
Interventional
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Cancer
Drug: Talazoparib
Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol
Other Name: MDV3800
Experimental: Talazoparib
Intervention: Drug: Talazoparib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 30, 2020
June 30, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Canada,   Hungary,   Moldova, Republic of,   Poland,   Russian Federation,   United Kingdom,   United States
 
 
NCT02921919
MDV3800-13
C3441010 ( Other Identifier: Alias Study Number )
2016-001972-31 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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