Title
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
Phase
Phase 1Lead Sponsor
Metronome TherapeuticsStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Nonhematologic MalignanciesIntervention/Treatment
vinorelbine ...Study Participants
12The 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.
Dose Level #1 PO for at least 7 days
Dose Level #2 PO for at least 7 days
Dose Level #3 PO for at least 7 days
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
