A Randomized Crossover Oral Bioavailability Study Comparing the Pharmacokinetics and Pharmacodynamics of Picoplatin Administered Orally With Picoplatin Administered Intravenously in Subjects With Advanced Non-Hematological Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- MTD
研究概览
简要总结
Picoplatin is a new platinum-based chemotherapy drug that has been studied in a variety of cancers. Phase 1 and 2 studies have demonstrated that picoplatin may be effective in patients whose cancer returns or does not improve after treatment with chemotherapy. In these studies, picoplatin was administered intravenously. A capsule containing picoplatin has been formulated. This study will investigate the activity of the oral capsule in humans. Participants with advanced solid tumors will be enrolled.
详细描述
The primary study design is a randomized, two-period crossover, open label study in which a single dose (Cycle 1) of picoplatin will be given either IV or by oral capsule, followed 4 weeks later by a single dose (Cycle 2) of picoplatin given either IV or by oral capsule (whichever route was not used in Cycle 1). Participants may continue to receive cycles of IV picoplatin every 3 weeks, beginning with Cycle 3, as part of a Continuation Study.
This study will determine the relative safety, bioavailability, pharmacokinetics, pharmacodynamics, and urinary excretion of picoplatin administered orally with reference to picoplatin administered intravenously.
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
- •Histological diagnosis of non-hematological malignancy.
- •Patients for whom no standard therapy exists and for whom, in the opinion of the investigator, treatments with single agent picoplatin is appropriate.
- •18 years of age or older.
- •ECOG performance status 0-
- •Life expectancy of at least 12 weeks.
- •(Additional inclusion criteria apply.)
排除标准
- •Symptomatic or uncontrolled brain metastases.
- •Prior radiation involving ≥ 30% of the total bone marrow space.
- •Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study.
- •Gastrointestinal surgery that might interfere with absorption of orally administered drug.
- •Active inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding.
- •Clinical evidence of pancreatic injury or active pancreatitis.
- •Female subjects who are pregnant or breastfeeding.
- •(Additional exclusion criteria apply.)
研究组 & 干预措施
1
two-period crossover, open label study in which a single dose (Cycle 1) of picoplatin will be given either IV or PO, followed 4 weeks later by a single dose (Cycle 2) of picoplatin given by the route not used for Cycle 1. Subjects subsequently may continue to receive IV picoplatin commencing with Cycle 3 in a Continuation Study.
干预措施: Picoplatin (Drug)
结局指标
主要结局
MTD
时间窗: MTD
Comparison of platinum levels excreted in urine from 0-8 and 8-24 hours after start of IV or oral drug
时间窗: PK
次要结局
未报告次要终点