Status:
UNKNOWN
A Study of Docetaxel Polymeric Micelles for Injection in Patients With Advanced Solid Tumors
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 safet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05254665
Start Date
February 1 2022
End Date
March 1 2024
Last Update
February 24 2022
Active Locations (10)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233099
2
The Forth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
3
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052