NCT05254665

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Docetaxel Polymeric Micelles for Injection	Docetaxel polymeric micelles，usage and quantity of Docetaxel polymeric micelles follows the clinical study proctol，not published.

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-12-01
• Completion: 2024-03-01
• First posted: 2022-02-24
• Last updated: 2022-02-24

Locations

10 sites across 1 country: China