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

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

Official Title: 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

Brief 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 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 6 cycles of chemotherapy, that each cycle is repeated every 21 days.
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 [ Time Frame: 126 day ]
    Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius.
  • Incidence of IV antibiotics administration [ Time Frame: 126 day ]
    IV antibiotics administration means that antibiotics are administered through intravenous route.


Original 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 [ Time Frame: 126 day ]
    Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temparature is more than 38.3 degrees celsius.
  • Incidence of IV antibiotics adminstration [ Time Frame: 126 day ]
    IV antibiotics adminstration means that antibiotics are administered through intravenous route.


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

Dates:
Date Received: January 19, 2012
Date Started: February 2012
Date Completion:
Last Updated: September 29, 2014
Last Verified: September 2014