A Phase Ib Study With Pegylated Recombinant Human Endostatin in Advanced / Metastatic NSCLC or Other Solid Tumors
NCT04413227 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2020-06-02
Summary
The primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.
Conditions
Interventions
- DRUG
-
Pegylated Recombinant Human Endostatin(PEG-ENDO)
PEG-ENDO 1 mg/kg or 2 mg/kg or 4 mg/kg or 6 mg/kg or 8 mg/kg+Docetaxel 75 mg/m2,once every 3 weeks at day 1
Sponsors & Collaborators
-
Jiangsu Simcere Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Huang Dingzhi, Ph.D · Tianjin Medical University Cancer Institute and Hospital
-
Li Lin, Ph.D · Beijing Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-02
- Primary Completion
- 2021-05-31
- Completion
- 2021-09-30
Countries
- China
Study Locations
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