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ClinicalTrials.gov ID

NCT05254665

Lead Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 2

Enrollment

110Estimated

Last Update Posted

Feb 24, 2022Actual

Start Date

Feb 2022Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Mar 2024Estimated

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

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.

• Advanced Solid Tumors

• Docetaxel Polymeric Micelles for Injection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.INDUSTRY

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