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

Status unconfirmed · Phase 1

Conditions studied: Nonhematologic Malignancies

In brief

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.

Key facts

Study ID

NCT00641160

Run by

Metronome Therapeutics

People needed

12

Starts

2008-03-01

Expected to finish

2008-11-01

Last updated by the study team

2008-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Texas Oncology PA; Sammons Cancer Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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