Nonhematologic Malignancies
Conditions
Keywords
vinorelbine, metronomic dosing, oral administration, nonhematologic malignancies, pharmacokinetics
Brief 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.
Interventions
DRUGvinorelbine tartrate
Dose Level #1 PO for at least 7 days
Sponsors
Metronome Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs | Assessed at each subject visit to the study center |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of orally administered vinorelbine | Samples collected on Study Days 1, 2, and 8 |
| Exploratory analysis of blood markers of biological activity | Blood samples collected at selected subject visits to the study center |
Countries
United States
Outcome results
None listed