An Open, Multi-cohort, Phase II Clinical Study Evaluating the Efficacy and Safety of Docetaxel Polymer Micelles for Injection in Patients With Advanced Malignant Solid Tumors
试验速览
- 阶段
- 2 期
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen
研究概览
简要总结
This study is an open, multi-cohort phase II clinical trial, the overall design is divided into two parts: dose confirmation stage and expansion stage. Dose confirmation stage is to evaluate the safety and tolerability of three dosing regimenes of docetaxel polymer micelle for injection in patients with advanced esophageal cancer, and to determine the best dosing regimenes for entering the expansion stage. The expansion stage iwas used to evaluate the efficacy and further safety of the best dosing regimen identified in the dose confirmation stage in patients with advanced solid tumors. All subjects in the dose confirmation stage and expansion stage will continue treatment according to the injection docetaxel micelle regimen they received at enrollment until the disease progresses or the investigator determines that continuing treatment with the study drug will not benefit, or any intolerable toxicity occurs, or they voluntarily withdraw, or for other reasons, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged 18~75 years old
- •Patients with histopathologically or cytologically confirmed advanced or metastatic solid tumors who have failed or are not eligible for standard therapy in the past
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •There are measurable tumors(RECIST 1.1)
排除标准
- •Previous palliative chemotherapy with docetaxel failed
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms
- •Has a history of serious cardiovascular disease
- •A history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV)
- •Active hepatitis B (HBsAg positive, HBV DNA>; ULN) or hepatitis C (HCV antibody positive and HCV RNA>ULN)
- •Has a history of allergies to yew medications
- •Pregnant or lactating women
- •The investigator considered that there were other reasons for the subjects' ineligibility for this clinical study
研究组 & 干预措施
Docetaxel Polymeric Micelles for Injection
Docetaxel Polymeric Micelles for Injection
干预措施: Docetaxel Polymeric Micelles for Injection (Drug)
结局指标
主要结局
Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen
时间窗: 2 years
Incidence of DLT（Dose limited toxicity）
Expansion stage: effect，ORR(Objective Response Rate ) by investigator
时间窗: 2 years
Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria
次要结局
- Dose confirmation stage: Objective Response Rate（ORR） by investigator(2 years)
- Dose confirmation stage: Progression free survival（PFS） by investigator(2 years)
- Dose confirmation stage: Disease Control Rate（DCR）by investigator(2 years)
- Dose confirmation stage: Overall Survival（OS）by investigator(2 years)
- Dose confirmation stage: Peak Plasma Concentration（Cmax）(Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）)
- Dose confirmation stage: Time to Peak（Tmax）(Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）)
- Dose confirmation stage: Half-life（t1/2）(Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）)
- Dose confirmation stage: Area under the plasma concentration versus time curve（AUC）(Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）)
- Dose confirmation stage: Mean Residence Time（MRT）(Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）)
- Expansion stage: Objective Response Rate（DoR）by investigator(2 years)
- Dose confirmation stage: Objective Response Rate（DoR）by investigator(2 years)
- Dose confirmation stage: Clearance（CL）(Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）)
- Dose confirmation stage: Volume of distribution（Vd）(Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）)
- Expansion stage：Progression free survival（PFS） by investigator(2 years)
- Expansion stage：Disease Control Rate（DCR）by investigator(1.5 year)
- Expansion stage：Overall Survival（OS）by investigator(2 years)
- Expansion stage: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(2 years)