Expired Study
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Dallas, Texas 75246


Purpose:

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.


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


NCT ID:

NCT00641160


Primary Contact:

Study Director
George Tidmarsh, MD, PhD
Metronome Therapeutics


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75246
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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