- Histological or cytological diagnosis of advanced solid tumors that is resistant to
standard therapy or for which no standard therapy is available.
- Age ≥18 years.
- ECOG Performance Status (PS) must be 0 or 1.
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
- Resolved acute effects of any prior therapy to baseline severity or Grade ≤1
- Patients with known brain metastases
- Major surgery within 4 weeks of starting study treatment
- Radiation therapy within 2 weeks of starting study treatment
- Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study
- Previous high dose chemotherapy requiring stem cell rescue
- Prior irradiation to >25% of the bone marrow
- Prior treatment with a Notch signal inhibitor
- Known malabsorption syndrome or other condition that may impair absorption of study
- Any of the following in the previous 6 months: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
- Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors
- Current use or anticipated need for known strong CYP3A4 inducers