Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies
This trial is active, not recruiting.
|Start date||March 2008|
|End date||November 2008|
|Trial size||12 participants|
|Trial identifier||NCT00641160, MT-CL002|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs
time frame: Assessed at each subject visit to the study center
Pharmacokinetics of orally administered vinorelbine
time frame: Samples collected on Study Days 1, 2, and 8
Exploratory analysis of blood markers of biological activity
time frame: Blood samples collected at selected subject visits to the study center
Male or female participants at least 18 years old.
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
|Official title||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|
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