Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of Simmitecan Monotherapy and Combination in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 243
- 试验地点
- 9
- 主要终点
- Cmax (maximum plasma concentration)
研究概览
简要总结
This study evaluates the safety, tolerability, preliminary efficacy and pharmacokinetics of Simmitecan in patients with advanced solid tumors and Simmitecan, 5-fluorouracil and Leucovorin Calcium,thalidomide in patients with advanced solid tumor or advanced/metastatic colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 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
Pharmacokinetic data investigation of Simmitecan
To further determine the pharmacokinetic (PK) characteristics of Simmitecan monotherapy in patients with advanced solid tumors
干预措施: Simmitecan (Drug)
Dose escalation study of Simmitecan combined therapy
To determine the maximum tolerated dose (MTD) of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced solid tumor
干预措施: Simmitecan (Drug)
Dose escalation study of Simmitecan combined therapy
To determine the maximum tolerated dose (MTD) of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced solid tumor
干预措施: 5-fluorouracil and Leucovorin Calcium (Drug)
Dose extension study of Simmitecan monotherapy
To preliminarily evaluate the anti-tumor activity of Simmitecan monotherapy in patients with advanced solid tumors, and to determine the recommended phase II dose (RP2D)
干预措施: Simmitecan (Drug)
Dose extension study of Simmitecan combined Thalidomide
To preliminarily evaluate the anti-tumor activity of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced/metastatic colorectal cancer (CRC), and to determine RP2D
干预措施: Simmitecan (Drug)
Dose extension study of Simmitecan combined Thalidomide
To preliminarily evaluate the anti-tumor activity of Simmitecan combined with 5-fluorouracil/Leucovorin Calcium in patients with advanced/metastatic colorectal cancer (CRC), and to determine RP2D
干预措施: Thalidomide (Drug)
Dose escalation&extension Simmitecan combined Thalidomide
To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with gastrointestinal tumors, and to determine RP2D and MTD
干预措施: Simmitecan (Drug)
Dose escalation&extension Simmitecan combined Thalidomide
To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with gastrointestinal tumors, and to determine RP2D and MTD
干预措施: Thalidomide (Drug)
Dose extension study of Simmitecan combined therapy
To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with specific tumors
干预措施: Simmitecan (Drug)
Dose extension study of Simmitecan combined therapy
To preliminarily evaluate the anti-tumor activity of Simmitecan combined with thalidomide in patients with specific tumors
干预措施: 5-fluorouracil and Leucovorin Calcium (Drug)
结局指标
主要结局
Cmax (maximum plasma concentration)
时间窗: before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan
Tmax (time to maximum plasma concentration)
时间窗: before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan
AUC (area under the plasma concentration-time curve)
时间窗: before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan
T½
时间窗: before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan
CL (systemic clearance)
时间窗: before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan
Vz (apparent volume of distribution)
时间窗: before administration (within 5 minutes before administration), 45 and 90 minutes after the start of the infusion of Simmitecan and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48 and 72 hours after the completion of infusion of Simmitecan
Adverse events (AE)
时间窗: AEs will be classified by type, incidence, severity (graded per NCI-CTCAE [version 4.03]), time to onset, seriousness and relationship
次要结局
- Objective response rate (ORR)(Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death.)
- progression free survival (PFS)(Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death.)
- CBR (clinical benefit rate)(Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death.)
- DCR (disease control rate)(Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death.)
- OS (overall survival)(Imaging examination will be performed for tumor assessment every 6 weeks (±7 days) from the first dose of Simmitecan until PD, intolerable toxicity, withdrawal of consent or death.)
- accumulative excretion rate(Accumulative excretion rate within 0-72 h after the first administration of Simmitecan.)