NCT00095914已完成1 期
Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol) And ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-007 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with ABI-007 in treating patients who have locally advanced or metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine whether a change in the formulation alters the pharmacokinetic profile of paclitaxel in the plasma of patients with incurable locally advanced or metastatic solid tumors treated with ABI-007 and paclitaxel.
Secondary
- Correlate pharmacokinetic data of this regimen with decrease in the neutrophil count at nadir in these patients.
- Determine the intra- and interindividual pharmacokinetic variability of ABI-007 in these patients.
- Determine protein binding of paclitaxel via measurement of α-1-acid glycoprotein and serum albumin levels in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供
研究者
研究点 (2)
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