Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies
- Registration Number
- NCT00641160
- Lead Sponsor
- Metronome Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 vinorelbine tartrate - Cohort 2 vinorelbine tartrate - Cohort 3 vinorelbine tartrate -
- Primary Outcome Measures
Name Time Method Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs Assessed at each subject visit to the study center
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Texas Oncology PA; Sammons Cancer Center
🇺🇸Dallas, Texas, United States