NCT01918241

Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

Saftey and Efficacy Phase II Study of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd., · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consist of a screening period and a 21-day chemotherapy period of the same chemotherapy treatment cycle(s).Screening the subjects according to the inclusion criteria and exclusion criteria before 2 weeks of chemotherapy, and the screening successfully patients will be eligible for this study. The 1st chemotherapy treatment cycle defined as subjects screening period, subjects will be treated with the TC or EC regimen on the 1st day, aiming to screen out Chemotherapy-induced Neutropenia of ≥grade 3 (ANC\<1.0×10\^9/L) who can have the eligible to enter the 2nd chemotherapy treatment cycle, otherwise to quit the study. On the 1st day in cycle 2, subjects will be treated with the same regimen as the 1st chemotherapy treatment cycle, and be received the test drugs or controlled from the 3rd day to observe the efficacy and safety. 【Primary Outcome Measures】: • Duration of ≥grade 3 neutropenia in cycle 2 【Secondary Outcome Measures】: * Incidence of ≥grade 3 neutropenia induce; * Incidence of febrile neutropenia; * Duration for ANC from chemotherapy finished to ANC nadir and the minimum ANC ; * Duration for ANC recovery from nadir to 2.0×10\^9/L.

Conditions

• Neutropenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-01-01
• First posted: 2013-08-07
• Last updated: 2015-11-10

Locations

1 site across 1 country: China