Advanced Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUGDocetaxel Polymeric Micelles for Injection
Docetaxel polymeric micelles，usage and quantity of Docetaxel polymeric micelles follows the clinical study proctol，not published.
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen | 2 years | Incidence of DLT（Dose limited toxicity） |
| Expansion stage: effect，ORR(Objective Response Rate ) by investigator | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose confirmation stage: Progression free survival（PFS） by investigator | 2 years | PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment according to the RECIST 1.1 criteria |
| Dose confirmation stage: Disease Control Rate（DCR）by investigator | 2 years | Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria |
| Dose confirmation stage: Overall Survival（OS）by investigator | 2 years | OS is the time interval from the date of randomization to death from any cause. |
| 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） | Area under the plasma concentration versus time curve |
| 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） | Peak Plasma Concentration，Maximum concentration of HT001 derived from plasma concentration-time profile |
| 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） | Time of peak blood concentration of HT001 derived from plasma concentration-time profile |
| 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） | Half-life of HT001 derived from plasma concentration-time profile |
| Dose confirmation stage: Objective Response Rate（ORR） by investigator | 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 |
| 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） | Volume of distribution of HT001 derived from plasma concentration-time profile |
| 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） | Mean Residence Time of HT001 derived from plasma concentration-time profile |
| Expansion stage: Objective Response Rate（DoR）by investigator | 2 years | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria |
| Expansion stage：Progression free survival（PFS） by investigator | 2 years | PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment according to the RECIST 1.1 criteria |
| Expansion stage：Disease Control Rate（DCR）by investigator | 1.5 year | Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria |
| Expansion stage：Overall Survival（OS）by investigator | 2 years | OS is the time interval from the date of randomization to death from any cause. |
| Expansion stage: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | 2 years | Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0 |
| 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） | Clearance of HT001 derived from plasma concentration-time profile |
| Dose confirmation stage: Objective Response Rate（DoR）by investigator | 2 years | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria |
Countries
China
Contacts
Primary ContactHongmei Lin, Ph.D
Backup ContactZhi Zhang, Bachelor
Outcome results
None listed