Clinical trial NCT05254665: A Study of Docetaxel Polymeric Micelles for Injection in Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen
timeFrame: 2 years
measure: Expansion stage: effect，ORR(Objective Response Rate ) by investigator
timeFrame: 2 years
Secondary outcomes:
measure: Dose confirmation stage: Objective Response Rate（ORR） by investigator
timeFrame: 2 years
measure: Dose confirmation stage: Objective Response Rate（DoR）by investigator
timeFrame: 2 years
measure: Dose confirmation stage: Progression free survival（PFS） by investigator
timeFrame: 2 years
measure: Dose confirmation stage: Disease Control Rate（DCR）by investigator
timeFrame: 2 years
measure: Dose confirmation stage: Overall Survival（OS）by investigator
timeFrame: 2 years
measure: Dose confirmation stage: Area under the plasma concentration versus time curve（AUC）
timeFrame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
measure: Dose confirmation stage: Peak Plasma Concentration（Cmax）
timeFrame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
measure: Dose confirmation stage: Time to Peak（Tmax）
timeFrame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
measure: Dose confirmation stage: Half-life（t1/2）
timeFrame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
measure: Dose confirmation stage: Clearance（CL）
timeFrame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
measure: Dose confirmation stage: Volume of distribution（Vd）
timeFrame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
measure: Dose confirmation stage: Mean Residence Time（MRT）
timeFrame: Day 1 to Day 3 of Cycle 1，each cycle is 21 （queue A and C）or 28 days（queue B）
measure: Expansion stage: Objective Response Rate（DoR）by investigator
timeFrame: 2 years
measure: Expansion stage：Progression free survival（PFS） by investigator
timeFrame: 2 years
measure: Expansion stage：Disease Control Rate（DCR）by investigator
timeFrame: 1.5 year
measure: Expansion stage：Overall Survival（OS）by investigator
timeFrame: 2 years
measure: Expansion stage: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 2 years
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Shijiazhuang
country: China
facility: The Forth Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute&Hospital
state: Tianjin
city: Jinhua
country: China
facility: Jinhua Municipal Hospital Medical Group
state: Zhejiang
Study officials:
affiliation: Shanghai East Hospital
name: Ye Guo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: