Chemotherapy Induced Neutropenia
Conditions
Keywords
Pegfilgrastim, neutropenia
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALGCPGC 3.6mg
Stage I:Single blinded
BIOLOGICALGCPGC 6mg
Stage I: Single blinded;
BIOLOGICALNeulasta (pegfilgrastim) 6mg
Stage II: Active comparator, double blinded
Sponsors
Symyoo
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women(≥ 18 years old) diagnosed with breast cancer who are receiving chemotherapy inducing neutropenia * body weight of 45kg and more * ECOG performance status 2 and less * ANC ≥1,500mm3 and Platelet ≥100,000/mm3 * life expectancy of 3 months and more * given written informed consent
Exclusion criteria
* had previous exposure to pegfilgrastim or filgrastim * had received systemic antibiotics within 72hrs of chemotherapy * prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m or epirubicin more than 600 mg/m
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of grade 4 neutropenia(ANC<500mm3) for cycle 1 | in 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to ANC recovery (≥2,000/mm3) after nadir in cycle 1 | in cycle 1 | — |
| Depth of ANC nadir in cycle 1 | in cycle 1 | — |
| Rates of Febrile neutropenia in all cycles | in all cycles | Stage I: only in cycle 1; Stage II: in all cycles |
| Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II) | in cycle 1 | — |
| Number of hospitalization due to febrile neutropenia in cycle 2 and after (only for Stage II) | in clycle 2-6 | — |
| Number of intravenous antimicrobial treatments due to febrile neutropenia | in all cycles | — |
| ANC values at Day 7 in all cycles (only for Stage II) | Day 7 in alll cycles | — |
| Rates of delay or dose-reduction of chemotherapy due to neutropenia (only for Stage II) | all cycles | — |
Other
| Measure | Time frame |
|---|---|
| Incidence of antibody development in patients receiving GCPGC compared to Neulasta | 3 months after last treatment |
| Vital sign, Physical examination, Laboratory tests, Occurrence of adverse reactions | in all cycles |
Countries
South Korea
Outcome results
None listed