Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 Patients With Malignancies Receiving Myelosuppressive Chemotherapy|
- Duration of grade 4 neutropenia in cycle 1 [ Time Frame: 21 day ] [ Designated as safety issue: No ]Grade 4 neutropenia means the ANC count is less than 500/mm3.
- ANC nadir in cycle 1 [ Time Frame: 21 day ] [ Designated as safety issue: No ]ANC nadir means the lowest point of ANC count.
- Time to ANC recovery in cycle 1 [ Time Frame: 21 day ] [ Designated as safety issue: No ]ANC recovery means the ANC count is more than 2,000/mm3.
- Incidence of febrile neutropenia [ Time Frame: 126 day ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]IV antibiotics administration means that antibiotics are administered through intravenous route.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
Other Name: DA-3031
Active Comparator: Leucostim®
Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle
Other Name: Leucostim®
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.
|Contact: JiSoo Song, Manageremail@example.com|
|Korea, Republic of|
|Korea University GURO hospital||Recruiting|
|Seoul, Korea, Republic of, 152-703|
|Contact: JaeHong Seo, M.D. firstname.lastname@example.org|
|Principal Investigator:||JaeHong Seo, M.D.||Korea University Guro Hospital|