An Open-Label Pharmacokinetics and Safety Study of Talazoparib

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT02997163

Run by

Pfizer

People needed

34

Starts

2017-02-21

Expected to finish

2019-01-30

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Female or male of at least 18 years of age.
• Histologically or cytologically confirmed advanced solid tumor with no available standard approved treatment options in the opinion of the Investigator
• Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 2.
• Expected life expectancy of ≥ 3 months.
• Able to swallow the study drug (no contra indication to oral agents).
• Renal function at screening and enrollment as defined by the Modification of Diet in Renal Disease (MDRD) equation.
• 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.
• Patient is not currently on hemodialysis and/or peritoneal dialysis for management of chronic kidney disease or acute failure/conditions.
• 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.
• Adequate other organ function at screening and enrollment.
• 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.
• 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.
• Female patients must not be breastfeeding at screening nor during the study participation until 45 days after the last dose of study drug.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

You may not qualify if…

• 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.
• 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.
• Major surgery within 28 days prior to enrollment.
• Serious accompanying cardiac disorder.
• Active known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment.
• Symptomatic or impending spinal cord compression or cauda equina syndrome.
• Has undergone a liver transplant, kidney transplant or nephrectomy.
• 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.
• Known myelodysplastic syndrome.
• Seropositive for human immunodeficiency virus (HIV).
• Any serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
• Gastrointestinal disorder affecting absorption.
• Known or suspected hypersensitivity to any of the talazoparib capsule components.
• 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.

Where it is running

• Fort Wayne Medical Oncology and Hematology, Inc. — Fort Wayne, Indiana, United States
• Fort Wayne Medical Oncology and Hematology, Inc. — Fort Wayne, Indiana, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Karmanos Cancer Institute Weisberg Cancer Treatment Center — Farmington Hills, Michigan, United States
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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