A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

This study is designed to evaluate the effects of talazoparib on cardiac repolarization in patients with advanced solid tumors with no available standard treatment options.

Key facts

Study ID

NCT03042910

Run by

Pfizer

People needed

38

Starts

2016-10-13

Expected to finish

2017-06-22

Last updated by the study team

2019-12-17

Who can join

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

You may qualify if…

• At least 18 years of age and willing and able to provide informed consent.
• Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Estimated life expectancy of ≥ 3 months.
• Able to swallow the study drug, have no known intolerance to the study drug or excipients, and comply with study requirements.
• Female patients of childbearing potential must have a negative 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 last dose of study drug.
• 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 study drug through 105 days after last dose of study drug. Contraception should be considered for a nonpregnant female partner of childbearing potential.
• Male and female patients must agree not to donate sperm or eggs, respectively, from the first dose of study drug through 105 days and 45 days after the last dose of study drug, respectively.
• Female patients may not be breastfeeding at screening and must not breastfeed during study participation through 45 days after the last dose of study drug.

You may not qualify if…

• Use of antineoplastic therapies within 21 days before day 1.
• Use of any other investigational agent within 21 days before day 1.
• Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ≤ 1) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
• Electrolyte abnormality that has not responded to correction, including hypokalemia or hypocalcemia less than the lower limit of normal, or hyperkalemia or hypercalcemia greater than the upper limit of normal (ULN).
• Major surgery within 14 days before day 1.
• Diagnosis of myelodysplastic syndrome (MDS) or a hematologic malignancy.
• Clinically significant cardiovascular disease.
• Significant organ dysfunction.
• Gastrointestinal disorder affecting absorption.
• Current or anticipated use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BCRP.
• Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator or medical monitor.

Where it is running

• CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• UCLA Hematology/Oncology - Burbank — Burbank, California, United States
• St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
• UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D. — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
• TRIO-US Central Administration — Los Angeles, California, United States
• UCLA Hematology/Oncology — Los Angeles, California, United States
• UCLA West Medical Pharmacy. Attn: Steven L. Wong, Pharm.D. — Los Angeles, California, United States
• UCLA Hematology/Oncology - Pasadena — Pasadena, California, United States
• UCLA Hematology/Oncology - Porter Ranch — Porter Ranch, California, United States
• Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates — Redondo Beach, California, United States
• UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
• UCLA Hematology/Oncology - Santa Clarita — Valencia, California, United States
• Memorial Cancer Institute at Memorial Regional Hospital — Hollywood, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Orlando Health, Inc. — Orlando, Florida, United States
• Memorial Hospital West — Pembroke Pines, Florida, United States
• Fort Wayne Medical Oncology and Hematology, Inc. — Fort Wayne, Indiana, United States
• Fort Wayne Medical Oncology and Hematology, Inc. — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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