Open-Label Extension and Safety Study of Talazoparib



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:November 8, 2016
End Date:September 30, 2020
Contact:Pfizer Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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.


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).
We found this trial at
27
sites
New Brunswick, New Jersey 08903
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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Fort Wayne, IN
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24 Sturtevant St
Orlando, Florida 32806
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Orlando, FL
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Alhambra, California 91801
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Alhambra, CA
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Bakersfield, CA
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Bloomington, Indiana
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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201 South Buena Vista Street
Burbank, California 91505
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Detroit, Michigan 48201
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Detroit, MI
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Edmonton, Alberta
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Edmonton,
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Fullerton, CA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Indianapolis, IN
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Indianapolis, Indiana 46202
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Indianapolis, Indiana 46202
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Los Angeles, California 90095
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Los Angeles, California 90095
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Pasadena, California 91105
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Pembroke Pines, Florida 33028
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Porter Ranch, California 91326
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Santa Monica, California 90404
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3445 Pacific Coast Highway
Torrance, California 90505
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Valencia, California 91355
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