A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: Talazoparib
Intervention description: Talazoparib 1 mg orally once daily.
Intervention MeSH terms: Talazoparib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age and willing and able to provide informed consent.

          2. Histologically or cytologically confirmed advanced solid tumor with no available
             standard treatment options in the opinion of the investigator.

          3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          4. Estimated life expectancy of ≥ 3 months.

          5. Able to swallow the study drug, have no known intolerance to the study drug or
             excipients, and comply with study requirements.

          6. 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.

          7. 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.

          8. 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.

          9. 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.

        Exclusion Criteria:

          1. Use of antineoplastic therapies within 21 days before day 1.

          2. Use of any other investigational agent within 21 days before day 1.

          3. 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.

          4. 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).

          5. Major surgery within 14 days before day 1.

          6. Diagnosis of myelodysplastic syndrome (MDS) or a hematologic malignancy.

          7. Clinically significant cardiovascular disease.

          8. Significant organ dysfunction.

          9. Gastrointestinal disorder affecting absorption.

         10. Current or anticipated use of a strong P-gp inhibitor, strong P-gp inducer, or strong
             inhibitor of BCRP.

         11. 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.