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

Simcere

Status and phase: Unknown; Phase 2

Conditions: Advanced Solid Tumors

Treatments: Drug: Docetaxel Polymeric Micelles for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05254665

B02B00903-DTAX-201

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Docetaxel Polymeric Micelles for Injection

Experimental group

Description:

Docetaxel Polymeric Micelles for Injection

Treatment:

Drug: Docetaxel Polymeric Micelles for Injection