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

Xiamen Amoytop Biotech

Status and phase: Completed; Phase 1

Conditions: Chemotherapy Patients

Treatments: Drug: YPEG-Filgrastim

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01238562

TB1004CSF

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 5 patient groups

YPEG-Filgrastim, 10mcg/kg

Experimental group

Treatment:

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

YPEG-Filgrastim, 20mcg/kg

Experimental group

Treatment:

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

YPEG-Filgrastim, 30mcg/kg

Experimental group

Treatment:

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

YPEG-Filgrastim, 45mcg/kg

Experimental group

Treatment:

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

YPEG-Filgrastim, 60mcg/kg

Experimental group

Treatment:

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim

Drug: YPEG-Filgrastim