An Open-Label Pharmacokinetics and Safety Study of Talazoparib



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:February 8, 2017
End Date:May 24, 2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A Phase I Open-label Pharmacokinetics And Safety Study Of Talazoparib (mdv3800) In Patients With Advanced Solid Tumors And Normal Or Varying Degrees Of Renal Impairment

This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients
with advanced solid tumors and impaired renal function.

At the End of the Study, patients with no clinically significant toxicities, no
contraindications to continue treatment with talazoparib, and no disease progression
(underlying cancer progression) may be eligible to continue talazoparib treatment in a
separate open-label extension study after discussion with the Principal Investigator and
obtaining Sponsor permission. Sponsor decision to allow the patient to continue dosing with
talazoparib in an open-label extension study will be based on potential overall benefit-risk,
patient acceptance and other relevant criteria.

Inclusion Criteria:

1. Signed and dated informed consent form (by the patient or a legally acceptable
representative as per the local regulations) obtained prior to initiation of any
study-specific procedure and treatment.

2. Female or male of at least 18 years of age.

3. Histologically or cytologically confirmed advanced solid tumor with no available
standard approved treatment options in the opinion of the Investigator

4. Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 2.

5. Expected life expectancy of ≥ 3 months.

6. Able to swallow the study drug (no contra indication to oral agents).

7. Renal function at screening and enrollment as defined by the Modification of Diet in
Renal Disease (MDRD) equation.

8. Patient has had no clinically significant change in renal status within 3 months prior
to screening, according to Investigator's review of clinical patient records.

9. Patient is not currently on hemodialysis and/or peritoneal dialysis for management of
chronic kidney disease or acute failure/conditions.

10. Patient has no unstable renal function, defined as a change in estimated glomerular
filtration rate (eGFR) (calculated with the MDRD equation) of > 25% for patients with
mild and moderate renal impaired or as a change in eGFR > 30% for patients with severe
renal impaired, from screening to enrollment.

11. Adequate other organ function at screening and enrollment.

12. Female patients of childbearing potential must have a negative serum pregnancy test at
screening, and must agree to use a highly effective birth control method from the time
of the first dose of study drug through 45 days after the last dose of study drug.

13. Male patients must agree to use a condom when having sex with a pregnant woman or with
a non-pregnant female partner of childbearing potential, from 21 days before the first
dose of study drug through 105 days after last dose of study drug.

14. Female patients must not be breastfeeding at screening nor during the study
participation until 45 days after the last dose of study drug.

15. Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other trial procedures.

Exclusion Criteria:

1. Treatment within 14 days or five half lives prior to enrollment with any type of
systemic anticancer-therapy or any investigational drug, whichever is longer.

2. Have not recovered (recovery is defined as CTCAE grade ≤ 1) from the acute toxicities
of previous anticancer standard or investigational therapy, except treatment-related
alopecia or laboratory abnormalities otherwise meeting eligibility requirements.

3. Major surgery within 28 days prior to enrollment.

4. Serious accompanying cardiac disorder.

5. Active known or suspected brain metastasis or active leptomeningeal disease undergoing
or requiring treatment.

6. Symptomatic or impending spinal cord compression or cauda equina syndrome.

7. Has undergone a liver transplant, kidney transplant or nephrectomy.

8. Prior allergic reaction or severe intolerance (meeting the criteria for a serious
adverse event, a grade 3 or 4 AE, or permanent treatment discontinuation) to a poly
ADP ribose polymerase (PARP) inhibitor.

9. Known myelodysplastic syndrome.

10. Seropositive for human immunodeficiency virus (HIV).

11. Any serious or unstable medical condition that interferes with ability to tolerate
treatment or assessments associated with the protocol.

12. Gastrointestinal disorder affecting absorption.

13. Known or suspected hypersensitivity to any of the talazoparib capsule components.

14. Any condition or reason that interferes with ability to participate in the study,
tolerate treatment or assessments associated with the protocol, causes undue risk, or
complicates the interpretation of safety data, in the opinion of the Investigator or
Medical Monitor.
We found this trial at
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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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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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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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Detroit, Michigan 48201
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Edmonton, Alberta
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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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New Brunswick, New Jersey 08903
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Saint Louis, Missouri 63110
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Diego, California 92121
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