NCT00096317已完成1 期
The Effect of Ketoconazole on the Pharmacokinetics and Pharmacodynamics of Ixabepilone In Patients With Advanced Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Effect of ketoconazole on the pharmacokinetics of ixabepilone
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving ixabepilone with ketoconazole may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving ixabepilone together with ketoconazole and to see how well they work in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the effect of ketoconazole on the pharmacokinetics of ixabepilone in patients with advanced solid tumors.
Secondary
- Determine the safety of ixabepilone when administered alone and in combination with ketoconazole in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed solid tumor
- •Unresponsive to currently available therapy OR no known effective treatment exists
- •Measurable or nonmeasurable disease
- •Brain metastases allowed, provided the following criteria are met:
- •Completed cranial radiotherapy at least 4 weeks ago
- •Stable or reduced brain metastases by brain imaging*
- •Clinically stable disease AND no steroid therapy within the past 2 weeks (Baseline brain imaging is not required for patients with no signs or symptoms of brain metastasis)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No more than 3 prior chemotherapy regimens
- •No other concurrent chemotherapy (standard or investigational)
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to > 25% of major bone-marrow containing areas (e.g., pelvis or lumbar spine)
- •At least 1 week since prior minor surgery and recovered
- •At least 3 weeks since prior major surgery and recovered
- •More than 2 weeks since prior drugs that would inhibit or stimulate drug metabolism
排除标准
- 未提供
结局指标
主要结局
Effect of ketoconazole on the pharmacokinetics of ixabepilone
次要结局
- Safety of ixabepilone with and without ketoconazole
- Antitumor activity
研究者
研究点 (1)
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