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

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

The purpose of this study is to determine the safety of oral administration of vinorelbine once daily for at least 7 days. The study will be conducted in subjects with a non-hematologic malignancy 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