Status:
UNKNOWN
Evaluation of the Safety and Efficacy of Albumin-bound Docetaxel
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This trial is an open-label, single-center, dose-escalation and cohort-expansion Phase I clinical study in patients with advanced solid tumors. The aim of this study is designed to evaluate the safety...
Detailed Description
This study was conducted in two stages. The first stage (Stage I) is a dose-escalation study. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD) and the recommended Phase ...
Eligibility Criteria
Inclusion
- Age ≥18, ≤75 years, no gender limitation；
- Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors, for which standard therapy either does not exist or has proven to be ineffective, intolerable or unacceptable for the patient；
- At least one measurable lesion as per RECIST version 1.1；
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1；
- Life expectancy ≥3 months；
- Adequate bone marrow, cardiac, liver and renal function；
Exclusion
- Chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatment within 4 weeks of the first dose of the study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indications；
- Currently enrolled in any other clinical study, or administration of other investigational agents w
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2023
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04471675
Start Date
December 2 2020
End Date
December 15 2023
Last Update
January 31 2022
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China