An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:September 30, 2016
End Date:May 27, 2020
Contact:Pfizer 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 HEPATIC IMPAIRMENT

This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in
patients with advanced solid tumors and impaired hepatic 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. The decision to allow the patient to continue dosing
with talazoparib in an open-label extension (OLE) study will be based on potential overall
benefit-risk and patient meeting eligibility criteria for OLE.

Inclusion Criteria:

1. Signed and dated Informed Consent Form (by the patient or a legally acceptable
representative as per the local regulations).

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

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

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

5. Expected life expectancy of ≥ 3 months.

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

7. Hepatic function at screening and enrollment as defined by the NCI organ dysfunction
working group (NCI-ODWG) criteria.

8. Adequate other organ function at screening and enrollment.

9. Female patients of childbearing potential must have a negative serum pregnancy test at
screening and must agree to use a highly effective form of contraception from the time
of the first dose of study drug through 7 months after the last dose of study drug.

10. 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 4 months after last dose of study drug.

11. Female patients must not be breastfeeding at screening nor during the study
participation until 7 months after the last dose of the study drug.

12. 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 whichever is longer
with any type of systemic anticancer-therapy or any investigational drug

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 needing
treatment

6. Symptomatic or impending spinal cord compression or cauda equine 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
15
sites
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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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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24 Sturtevant St
Orlando, Florida 32806
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Alhambra, California 91801
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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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Fullerton, CA
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Los Angeles, California 90095
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Los Angeles, California 90095
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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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