Open-Label Extension and Safety Study of Talazoparib

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-08

Study Completion Date

2021-07-20

Brief Summary

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This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Talazoparib

Group Type EXPERIMENTAL

Talazoparib

Intervention Type DRUG

Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol

Interventions

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Talazoparib

Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol

Intervention Type DRUG

Other Intervention Names

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MDV3800

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UCLA Hematology/Oncology - Alhambra

Alhambra, California, United States

Site Status

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Site Status

UCLA Hematology/Oncology - Burbank

Burbank, California, United States

Site Status