NCT00046111已完成1 期
A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- To determine the bioequivalence of new formulation (test) of oral topotecan relative to the current Phase III formulation (reference) of oral topotecan by comparing AUC in patients with advanced solid tumors.
研究概览
简要总结
The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Written informed consent
- •Patients with confirmed advanced solid tumors.
- •No prior chemotherapy within 5 years of the diagnosis of SCLC (small cell lung cancer).
- •At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
- •Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
- •Exclusion criteria:
- •Women who are pregnant or lactating.
- •Patients of child bearing potential refusing to practice adequate contraception.
- •Patients with uncontrolled vomiting.
- •Active infection.
- •Patients with clinical evidence of any gastrointestinal (GI) conditions which would alter GI absorption or GI motility.
- •Patients requiring treatment with cyclosporin A.
- •Severe medical problems other than the cancer, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
- •Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for cancer treatment.
- •Use of investigational drug within 30 days prior to the first dose of study medication.
排除标准
- 未提供
研究组 & 干预措施
Primary Group
Experimental
40 subjects on medium doses of Topotecan and tested for bioequivalence for 4 weeks.
干预措施: topotecan (Drug)
结局指标
主要结局
To determine the bioequivalence of new formulation (test) of oral topotecan relative to the current Phase III formulation (reference) of oral topotecan by comparing AUC in patients with advanced solid tumors.
时间窗: Four weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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