A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: Talazoparib; Itraconazole; Rifampin
Intervention description: Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose; 100 mg oral dose; 600 mg oral dose
Intervention MeSH terms: Itraconazole; Rifampin; Talazoparib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study in patients with advanced solid tumors for the investigation of P-gp
      inhibition and induction on the PK of talazoparib.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Arm A: At least 18 years of age and <65 years of age (at the time point of consent)
             and willing and able to provide informed consent. Arm B: At least 18 years of age (at
             the time point of consent) 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. ECOG performance status ≤ 2 at screening and at time of enrollment.

          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 are of childbearing potential using a highly effective
             form of contraceptive, and female subjects should not donate eggs from the time point
             of investigational medicinal product (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, and
             do not donate sperm from the time point of study drug administration until at least
             105 days thereafter, and males should not donate sperm from the time point of study
             drug administration until at least 105 days thereafter.

          8. Female subjects 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 days or 5 half lives 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. Subjects 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 capsule components.

         11. 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].