Status:
UNKNOWN
Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies
Lead Sponsor:
Metronome Therapeutics
Conditions:
Nonhematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00641160
Start Date
March 1 2008
End Date
November 1 2008
Last Update
September 26 2008
Active Locations (1)
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1
Texas Oncology PA; Sammons Cancer Center
Dallas, Texas, United States, 75246