Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

Summary

This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.

Conditions

• Neutropenia

Interventions

DRUG

pegfilgrastim,30mcg/kg

Two doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2.

DRUG

pegfilgrastim, 60mcg/kg

Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.

DRUG

pegfilgrastim, 100mcg/kg

Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.

DRUG

filgrastim, 5mcg/kg

At least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Jiangsu Cancer Institute & Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Wuhan TongJi Hospital

  collaborator OTHER

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Changsha Central Hospital

  collaborator OTHER

• Yangzhou No.1 People's Hospital

  collaborator OTHER

• Subei People's Hospital of Jiangsu Province

  collaborator OTHER

• Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

  lead INDUSTRY

Principal Investigators

• Yuankai Shi · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2016-01-31

Countries

• China

Study Locations