NCT00641160Unknown1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 1
Experimental
干预措施: vinorelbine tartrate (Drug)
Cohort 2
Experimental
干预措施: vinorelbine tartrate (Drug)
Cohort 3
Experimental
干预措施: vinorelbine tartrate (Drug)
结局指标
主要结局
Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs
时间窗: Assessed at each subject visit to the study center
次要结局
- 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)
研究者
研究点 (1)
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