A Study of Docetaxel Polymeric Micelles for Injection in Patients With Advanced Solid Tumors
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
1 other identifier
interventional
110
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2022
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2022
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedFebruary 24, 2022
February 1, 2022
10 months
January 19, 2022
February 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Dose confirmation stage: Safety and tolerability to determine the subsequent recommended dosing regimen
Incidence of DLT（Dose limited toxicity）
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
2 years
Secondary Outcomes (17)
Dose confirmation stage: Objective Response Rate（ORR） by investigator
2 years
Dose confirmation stage: Objective Response Rate（DoR）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
- +12 more secondary outcomes
Study Arms (1)
Docetaxel Polymeric Micelles for Injection
EXPERIMENTALDocetaxel Polymeric Micelles for Injection
Interventions
Docetaxel polymeric micelles，usage and quantity of Docetaxel polymeric micelles follows the clinical study proctol，not published.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233099, China
The Forth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123, China
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, 300181, China
Jinhua Municipal Hospital Medical Group
Jinhua, Zhejiang, 321099, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ye Guo, Ph.D
Shanghai East Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2022
First Posted
February 24, 2022
Study Start
February 1, 2022
Primary Completion
December 1, 2022
Study Completion
March 1, 2024
Last Updated
February 24, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share