Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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 relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.
• Collaborator: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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