A Phase 2/3 interventional study of GCPGC 3.6mg and GCPGC 6mg in Chemotherapy Induced Neutropenia, sponsored by Green Cross Corporation. Completed at 15 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-06.
Sponsored by Green Cross Corporation · Phase 2/3, Interventional, and Prevention
This study is adaptive design and it consists of stage I and stage II.
Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia. 2 Different doses of GCPGC will be investigated in a total of 60 Breast cancer patients who are receiving chemotherapy.
Stage II is multi-center, parallel-group, double-blind,phase III study to evaluate the efficacy and safety of once per cycle GCPGC in chemotherapy-induced neutropenia compared to Neulasta (pegfilgrastim). A total of 120 patients receiving chemotherapy will participate into this phase.
GCPGC ia a solution for containing pegfilgrastim. Pegfilgrastim is a covalent conjugate of recombinant human granulocyte colony-stimulating factor (G-CSF) with a polyethylene glycol (PEG) which has long half life compared to filgrastim, resulting in dosing advantage.
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's enrollment of 177 is above the median of 93 across 276 interventional studies indexed under Neutropenia.
Browse Neutropenia studies →Green Cross Corporation is the lead sponsor of 61 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
Biological: GCPGC 3.6mg
GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1)
Biological: GCPGC 6mg
GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1). The recommended dose in Stage II was determinated as GCPGC 6mg in Stage I.
Biological: GCPGC 6mg
Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1)
Biological: Neulasta (pegfilgrastim) 6mg
Stage I:Single blinded
Also known as: Pegfilgrastim
Stage I: Single blinded;
Also known as: Pegfilgrastim
Stage II: Active comparator, double blinded
Experimental: Stage II
Also known as: Pegfilgrastim
Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1
Stage I: The difference in mean duration of grade 4 neutropenia between GCPGC 3.6mg and GCPGC 6mg is measured by check ANC in cycle I. Stage II : The difference in mean duration of grade 4 neutropenia between GCPGC which dose was determined at Stage I and Neulasta is measured by check ANC in cycle 1.
Time frame: in cycle 1
Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1
Time frame: in cycle 1
Depth of ANC nadir in cycle 1
Time frame: in cycle 1
Rates of Febrile neutropenia in all cycles
Stage I: only in cycle 1; Stage II: in all cycles
Time frame: in all cycles
Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II)
Time frame: in cycle 1
ANC values at Day 7 in all cycles (only for Stage II)
Time frame: Day 7 in alll cycles
Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II)
Time frame: all cycles
Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II)
Time frame: in clycle 2-6
Number of intravenous antimicrobial treatments due to febrile neutropenia
Time frame: in all cycles
Incidence of antibody development in patients receiving GCPGC compared to Neulasta
Time frame: 3 months after last treatment
Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions
Time frame: in all cycles
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Green Cross Corporation