- Histological or cytological diagnosis of locally advanced or metastatic solid tumor
that is resistant to standard therapy or for which no standard therapy is available.
- ECOG Performance Status 0 or 1.
- Adequate Bone Marrow, Renal and Liver Function.
- Able to take oral medications.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1.
- Serum or urine pregnancy test (for females of childbearing potential) negative at
screening.
- Patients with known symptomatic brain metastases requiring steroids.
- Major surgery within 4 weeks prior to the first dose of study treatment.
- Radiation therapy within 4 weeks prior to the first dose of study treatment.
- Any antitumor systemic cytotoxic therapies and/or treatment with immune modulators
within 4 weeks prior to the first dose of study treatment.
- Previous high dose chemotherapy requiring stem cell rescue.
- Prior irradiation to >25% of the bone marrow.
- Active and clinically significant bacterial, fungal, or viral infection
- Myocardial infarction within 6 months before starting therapy, symptomatic congestive
heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication.
- Hypertension that cannot be controlled by medications.
- Participation in other studies involving investigational drug(s) within 4 weeks prior
to the first dose of study treatment.
- Other acute or chronic medical or psychiatric condition, or laboratory abnormality
that may increase the risk associated with study participation or investigational
product administration or may interfere with the interpretation of study results and
would make the patient inappropriate for entry into this study.
- Fertile male patients and female patients of childbearing potential who are unwilling
or unable to use 2 highly effective methods of contraception and for 180 days after
the last dose of investigational product.
- Breastfeeding at screening or at any time during study participation.
- Current use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of
BCRP within 1 week or 5 half lives which ever is longer prior to the first dose of
study treatment.