An Open-Label, One-Arm, One-Sequence Crossover Drug-Drug Interaction Study in Advanced Solid Tumor Subjects Subjects to Evaluate the Potential Effect of Custirsen (OGX-011) on the Pharmacokinetics of Paclitaxel
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- To evaluate the impact of custirsen on paclitaxel pharmacokinetics
研究概览
简要总结
The primary goal of this study is to determine if custirsen has an effect on the way the body distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study will also evaluate if custirsen influences the way the body distributes and gets rid of carboplatin (another standard administered chemotherapy) and will measure custirsen blood levels in this cancer population. Finally, the study will evaluate the safety and tolerability of adding custirsen to the standard paclitaxel/carboplatin chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Confirmed diagnosis of a solid tumor that is refractory to standard therapies and is not amenable to treatment with established curative or palliative therapies and for whom paclitaxel and carboplatin is deemed an acceptable treatment by the investigator
- •Males or females ≥18 years of age
- •Life expectancy of ≥12 weeks
- •Minimum of 1 lesion
- •ECOG performance status of 0, 1 or 2
- •Adequate bone marrow reserve
- •Adequate renal and liver function
排除标准
- •Brain metastases that are symptomatic or require ongoing treatment
- •Major trauma or surgery within last 2 months, acute infection within 2 weeks (14 days), or radiotherapy, chemotherapy, immunotherapy or hormonal therapy within past 4 weeks
- •Persistent grade 2 or greater toxicity related to prior therapy
- •Grade 2 or greater peripheral neuropathy
- •Recent or current use of Cyp3A4, Cyp2C8 or P-gp inhibitors
- •Recent or current use of CYP enzyme inducers
研究组 & 干预措施
Paclitaxel/carboplatin with custirsen
Custirsen added to standard paclitaxel/carboplatin chemotherapy
干预措施: Custirsen, paclitaxel and carboplatin (Drug)
结局指标
主要结局
To evaluate the impact of custirsen on paclitaxel pharmacokinetics
时间窗: 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
The maximum peak concentration of paclitaxel after administration.
次要结局
- To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy(0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion)