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A Study of Docetaxel Polymeric Micelles for Injection in Patients With Advanced Solid Tumors

NCT05254665 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-02-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Docetaxel Polymeric Micelles for Injection

Docetaxel polymeric micelles，usage and quantity of Docetaxel polymeric micelles follows the clinical study proctol，not published.

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ye Guo, Ph.D · Shanghai East Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-12-31
Completion
2024-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254665 on ClinicalTrials.gov