A Phase 1 Study of the Safety, Pharmacokinetics, and Biological Activity of Metronomic Dosing With Orally Administered Vinorelbine Tablets in Subjects With Non-Hematologic Malignancies For Which There Are No Currently Accepted Therapies

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