Status:
UNKNOWN
A Phase Ib Study With Pegylated Recombinant Human Endostatin in Advanced / Metastatic NSCLC or Other Solid Tumors
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions:
NSCLC
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Detailed Description
This is a multicenter, open-label, dose-escalation study in subjects with advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.There will be five cohorts planning as followin...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent.
- 18-70years old, male or female.
- Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer(NSCLC) or other solid tumor, previous treated with standard therapy , or standard therapy not suitabl ,or without standard therapy.
- At least one measurable disease according to RECIST v1.1.
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Demonstrate adequate organ function -
Exclusion
- uncontrolled primary CNS tumors, brain metastases, or meningeal metastases.
- Evidence of a tumor that compresses or invades major blood vessels.
- History of hemoptysis (\>1/2 teaspoon per event) or severe bleeding or evidence of bleeding disorders in the last 3 months.
- Clinically significant active cardiovascular disease within 6 months prior to planned start of PEG-ENDO.
- Prior treatment with anti-agiogenetic agent.
- Pregnant female patients; breastfeeding female patients.
- \-
Key Trial Info
Start Date :
April 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04413227
Start Date
April 2 2020
End Date
September 30 2021
Last Update
June 2 2020
Active Locations (2)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100005
2
Tianjin medical university cancer institute&hospital
Tianjin, Tianjin Municipality, China, 300060