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 |
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.
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
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
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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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1515 Holcombe Blvd
Houston, Texas 77030
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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Los Angeles, California 90095
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