A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Solid Tumor
NCT04719065 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2021-11-01
Summary
This is a multicenter, randomized, open-label, phase Ib study to evaluate the safety, efficacy and pharmacokinetic characteristics of Mitoxantrone Hydrochloride Liposome in subjects with advanced solid tumor.
Conditions
- Advanced Solid Tumor
Interventions
- DRUG
-
Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)
Subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/ m2, IV, on day 1 of each cycle for a maximum of 8 cycles.
Sponsors & Collaborators
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yehui Shi, MD · Tianjin Medical University Cancer Institute and Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-13
- Primary Completion
- 2022-04-13
- Completion
- 2024-04-13
Countries
- China
Study Locations
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