- Advanced cancer for which there is no treatment available which would have a
reasonable chance of disease palliation or cure
- Age greater than or equal to 18.
- SWOG performance Status less than or equal to 2.
- Meets protocol requirements for specified laboratory values.
- Written informed consent and cooperation of patient.
- Prior treatment with an FPTI
- Knowledge of intracranial metastases or carcinomatous meningitis.
- Poor medical risks because of nonmalignant systemic disease or uncontrolled active
- Medical conditions that would interfere with taking oral medications.
- Significant uncontrolled diarrhea.
- Chemotherapy, radiotherapy or major surgery within 4 weeks; full recovery from prior
- Concomitant use of CYP3A inhibitors/inducers per protocol.
- Known HIV positivity or AIDS-related illness.
- Pregnant or nursing women.
- Men or women of childbearing potential who are not using an effective method of
- Concurrent chemotherapy, hormonal therapy, radiotherapy or immunotherapy.
- QTc prolongation (>440 msecs) at baseline.
- Patients with previous high-dose therapy requiring stem cell rescue or bone marrow
transplant, or irradiation to >30% of bone marrow-containing areas.
- Patients that have received Mitomycin-C or nitrosoureas.