E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（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
研究组 & 干预措施
E7080 (Dose Escalation Cohort)
This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
干预措施: E7080 (Drug)
E7080 (Dose Escalation Cohort)
This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
干预措施: Paclitaxel (Drug)
E7080 (Dose Escalation Cohort)
This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin.
干预措施: Carboplatin (Drug)
E7080 (Expansion Cohort)
Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
干预措施: E7080 (Drug)
E7080 (Expansion Cohort)
Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
干预措施: Paclitaxel (Drug)
E7080 (Expansion Cohort)
Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1
Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.
次要结局
- Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.(At Screening, on Day 22 of every even cycle, and at discontinuation)
- Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.(At various time points until Day 22 of Cycle 1)
- To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.(Throughout the study until 30 days after last dose)