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

Phase 1

Completed

• Conditions: Chemotherapy Patients
• Interventions: Drug: YPEG-Filgrastim

• Registration Number: NCT01238562
• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-04
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
YPEG-Filgrastim, 10mcg/kg	YPEG-Filgrastim	-
YPEG-Filgrastim, 20mcg/kg	YPEG-Filgrastim	-
YPEG-Filgrastim, 30mcg/kg	YPEG-Filgrastim	-
YPEG-Filgrastim, 45mcg/kg	YPEG-Filgrastim	-
YPEG-Filgrastim, 60mcg/kg	YPEG-Filgrastim	-

Primary Outcome Measures

Name	Time	Method
Measurement of absolute neutrophil counts in the 3 cycles for pharmacodynamic study.	each cycle

Secondary Outcome Measures

Name	Time	Method
Measurement of serum concentration of drugs for Pharmacokinetic study.	each cycle

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China