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

• Status: Unknown status
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Metronome Therapeutics
• Treatments: Vinblastine; Vinorelbine

Criteria

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