Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients
Lead Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Chemotherapy Patients
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response rela...
Eligibility Criteria
Inclusion
- Age: 18～70yrs
- Signed informed consent
- Confirmed malignant tumor patients by histopathological or cytological diagnosis, suitable for chemotherapy with carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin
- Karnofsky score ≥70
- Life expectancy \>3 months
- WBC≥3,500 per cubic milliliter, ANC≥1,500 per cubic milliliter, PLT≥100,000 per cubic milliliter
- Normal coagulation function, no evidences of hemorrhage
- Normal liver, heart, kidney function
Exclusion
- Pregnant or lactating females
- Proven active infectious diseases (e.g. viral hepatitis, TB)
- Not adequately controlled infections
- Known hypersensitivity to filgrastim or any other components of the study drug
- Unstable or uncontrolled cardiac disease or hypertension
- Currently participated in any other clinical trials
- Patients with previous or expected to receive systemic radiotherapy
- Evidence of metastatic disease in bone marrow, brain, et al
- Alcoholic or drug abusers
- Other conditions which in the opinion of the investigator preclude enrollment into the study
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01238562
Start Date
April 1 2010
End Date
November 1 2011
Last Update
February 4 2013
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021