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
Porter Ranch, California 91326
1982
mi
from 43215
Porter Ranch, CA
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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...
643
mi
from 43215
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...
137
mi
from 43215
Fort Wayne, IN
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24 Sturtevant St
Orlando, Florida 32806
795
mi
from 43215
Orlando, FL
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Alhambra, California 91801
1964
mi
from 43215
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...
164
mi
from 43215
Ann Arbor, MI
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1982
mi
from 43215
Bakersfield, CA
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Bloomington, Indiana
194
mi
from 43215
Bloomington, IN
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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...
643
mi
from 43215
Boston, MA
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201 South Buena Vista Street
Burbank, California 91505
1973
mi
from 43215
Burbank, CA
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Detroit, Michigan 48201
164
mi
from 43215
Detroit, MI
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Edmonton, Alberta
1700
mi
from 43215
Edmonton,
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1959
mi
from 43215
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...
995
mi
from 43215
Houston, TX
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167
mi
from 43215
Indianapolis, IN
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Indianapolis, Indiana 46202
166
mi
from 43215
Indianapolis, IN
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Indianapolis, Indiana 46202
167
mi
from 43215
Indianapolis, IN
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1972
mi
from 43215
Los Angeles, CA
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1972
mi
from 43215
Los Angeles, CA
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Los Angeles, California 90095
1982
mi
from 43215
Los Angeles, CA
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Los Angeles, California 90095
1982
mi
from 43215
Los Angeles, CA
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New Brunswick, New Jersey 08903
453
mi
from 43215
New Brunswick, NJ
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Pasadena, California 91105
1965
mi
from 43215
Pasadena, CA
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Pembroke Pines, Florida 33028
976
mi
from 43215
Pembroke Pines, FL
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Santa Monica, California 90404
1986
mi
from 43215
Santa Monica, CA
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3445 Pacific Coast Highway
Torrance, California 90505
1984
mi
from 43215
Torrance, CA
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Valencia, California 91355
1981
mi
from 43215
Valencia, CA
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