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.
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.