NCT01674855

Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

Randomized, Open, Multi-Center, Phase III Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily G-CSF in chemotherapy-induced neutropenia.

Detailed description

Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle is repeated every 21 days.

Conditions

• Chemotherapy Induced Neutropenia

Interventions

Type	Name	Description
DRUG	PEG-G-CSF	Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
DRUG	G-CSF	Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-02-01
• Completion: 2013-05-01
• First posted: 2012-08-29
• Last updated: 2014-10-01

Locations

1 site across 1 country: South Korea