Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies

Inclusion Criteria: * capable of understanding study requirements and able to provide Informed Consent * diagnosed with a non-hematologic malignancy for which there are no currently accepted therapies * life expectancy at least 3 months * agreement to use medically acceptable contraception throughout the study * willing and able to comply with the protocol requirements Exclusion Criteria: * currently receiving systemic treatment for malignancy * not yet recovered from the toxicity of prior therapies * platelet count \< 100,000 cells/mm3 within 7 days prior to study entry * ANC \< 1500 cells/mm3 within 7 days prior to study entry * hemoglobin \< 8.5 g/dL within 7 days prior to study entry * AST and/or ALT \> 2.5 X ULN within 7 days prior to study entry * total bilirubin \> 1.5 X ULN within 7 days prior to study entry * creatinine clearance \< 60 mL/min (Cockroft-Gault formula) within 7 days prior to study entry * receipt of any investigational therapy within 3 weeks prior to study entry * known history of HIV, HBV, and/or HCV infection * clinically relevant active infection or serious co-morbid medical condition at study entry * major surgery within 4 weeks prior to study entry * other malignancy within 3 year prior to study entry * pregnant or breast-feeding * presence of a concomitant disease or condition which, in the opinion of the Investigator, could interfere with the conduct of the study or could put the subject at unacceptable risk