A Study of Talazoparib in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: Talazoparib
Intervention description: 1 mg of talazoparib containing100 μCi of 14C-radiolabeled talazoparib
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: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the mass balance of talazoparib after a single dose of talazoparib.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least 18 years of age and willing and able to provide informed consent.

          2. Histologically confirmed advanced solid tumor (limited to platinum-resistant ovarian
             carcinoma, cervical adenocarcinoma, small cell lung carcinoma or triple-negative
             breast cancer) judged by the Investigator to not be appropriate for standard therapy.

          3. Eastern Co-Operative Oncology Group (ECOG) performance status ≤ 2 at screening and Day
             -1.

          4. Expected life expectancy of ≥ 3 months.

          5. Able to swallow the study drug and comply with study requirements.

          6. Female subjects may be enrolled if they are considered not of childbearing potential,
             or who are post-menopausal, or of childbearing potential using a highly effective form
             of contraception, and female subjects should not donate eggs from the time point of
             IMP administration until at least 45 days thereafter.

          7. Males with partners of childbearing potential may be enrolled if they use a condom
             when having sex with a pregnant woman or with a woman of childbearing potential from
             21 days before the first dose of study drug through 105 days after the last dose of
             study drug, and males should not donate sperm from the time point of study drug
             administration until at least 105 days thereafter.

          8. Female patients must not be breastfeeding at screening and during the study
             participation until 45 days after the last dose of the study drug.

          9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory
             tests, and other trial procedures.

        Exclusion Criteria:

          1. Treatment within 14 weeks or five half-live prior to dosing with any type of systemic
             anticancer therapy or any investigational agent, whichever is longer.

          2. Major surgery within 8 weeks before screening.

          3. Serious accompanying disorder or impaired organ function.

          4. Symptomatic or impending spinal cord compression or cauda equina syndrome.

          5. Non-healing wound, ulcer, or bone fracture, not including a pathological bone fracture
             caused by a pre-existent pathological bone lesion.

          6. Known myelodysplastic syndrome.

          7. Patients with the following serologies should be excluded: HBsAg+ or anti-HBc+; HCV+;
             HIV+.

          8. Serious or unstable medical condition that interferes with ability to tolerate
             treatment or assessments associated with the protocol.

          9. Gastrointestinal disorder affecting absorption.

         10. Known hypersensitivity to any of the talazoparib solution components.

         11. Use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BRCP
             within 7 days or 5 half-lives, whichever is longer, before Day 1.

         12. Any condition or reason 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 Sponsor (e.g. non-compliance, excessive alcohol consumption,
             intake of drugs of abuse unless these drugs are medically indicated [e.g. opiates for
             pain relief]).