A Phase 2 interventional study of Docetaxel Polymeric Micelles for Injection in Advanced Solid Tumors, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Status unknown at 10 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 110 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 75 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Docetaxel Polymeric Micelles for Injection
Drug: Docetaxel Polymeric Micelles for Injection
Docetaxel polymeric micelles，usage and quantity of Docetaxel polymeric micelles follows the clinical study proctol，not published.
Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen
Incidence of DLT（Dose limited toxicity）
Time frame: 2 years
Expansion stage: effect，ORR(Objective Response Rate ) by investigator
Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria
Time frame: 2 years
Dose confirmation stage: Objective Response Rate（ORR） by investigator
Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria
Time frame: 2 years
Dose confirmation stage: Objective Response Rate（DoR）by investigator
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria
Time frame: 2 years
Dose confirmation stage: Progression free survival（PFS） by investigator
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
Time frame: 2 years
Dose confirmation stage: Disease Control Rate（DCR）by investigator
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
Time frame: 2 years
Dose confirmation stage: Overall Survival（OS）by investigator
OS is the time interval from the date of randomization to death from any cause.
Time frame: 2 years
Dose confirmation stage: Area under the plasma concentration versus time curve（AUC）
Area under the plasma concentration versus time curve
Time frame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
Dose confirmation stage: Peak Plasma Concentration（Cmax）
Peak Plasma Concentration，Maximum concentration of HT001 derived from plasma concentration-time profile
Time frame: 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）
Time of peak blood concentration of HT001 derived from plasma concentration-time profile
Time frame: 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）
Half-life of HT001 derived from plasma concentration-time profile
Time frame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
Dose confirmation stage: Clearance（CL）
Clearance of HT001 derived from plasma concentration-time profile
Time frame: 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）
Volume of distribution of HT001 derived from plasma concentration-time profile
Time frame: 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）
Mean Residence Time of HT001 derived from plasma concentration-time profile
Time frame: 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
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria
Time frame: 2 years
Expansion stage：Progression free survival（PFS） by investigator
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
Time frame: 2 years
Expansion stage：Disease Control Rate（DCR）by investigator
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
Time frame: 1.5 year
Expansion stage：Overall Survival（OS）by investigator
OS is the time interval from the date of randomization to death from any cause.
Time frame: 2 years
Expansion stage: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Time frame: 2 years
Plan to share: No
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Jiangsu Simcere Pharmaceutical Co., Ltd.