Clinical Trial: Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multi-Center, Randomized, Open, Phase II Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in

Brief Summary: This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared to daily G-CSF in chemotherapy-induced neutropenia.

Detailed Summary: 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 1 cycles of chemotherapy.
Sponsor: Dong-A ST Co., Ltd.

Current Primary Outcome: Duration of grade 4 neutropenia in cycle 1 [ Time Frame: 21 day ]

Grade 4 neutropenia means the ANC count is less than 500/mm3.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ANC nadir in cycle 1 [ Time Frame: 21 day ]
    ANC nadir means the lowest point of ANC count.
  • Time to ANC recovery in cycle 1 [ Time Frame: 21 day ]
    ANC recovery means the ANC count is more than 2,000/mm3.
  • Incidence of febrile neutropenia in cycle 1 [ Time Frame: 21 day ]
    Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius.
  • Incidence of IV antibiotics administration in cycle 1 [ Time Frame: 21 day ]
    IV antibiotics administration means that antibiotics are administered through intravenous route.


Original Secondary Outcome: Same as current

Information By: Dong-A ST Co., Ltd.

Dates:
Date Received: August 13, 2013
Date Started: July 2010
Date Completion:
Last Updated: September 29, 2014
Last Verified: September 2014