GCPGC in Chemotherapy-induced Neutropenia

Study Overview
=================
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.

Official Title
-----------------
A Randomized,Multi-center,Parallel-group, Phase II(Single-blind)/Phase III(Double- Blind)Study to Determine the Optimal Dose and to Evaluate the Efficacy and Safety of GCPGC on Chemotherapy-induced Neutropenia Compared to Neulasta(Pegfilgrastim)

Conditions
-----------------
Chemotherapy Induced Neutropenia

Intervention / Treatment
-----------------
* Biological: GCPGC 3.6mg
* Biological: GCPGC 6mg
* Biological: Neulasta (pegfilgrastim) 6mg
* Biological: GCPGC 6mg


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage I - Arm I: GCPGC I (3.6mg)<br>GCPGC 3.6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1) | Biological: GCPGC 3.6mg<br>* Stage I:Single blinded<br>* Other names: Pegfilgrastim;|
| Experimental: Stage I - Arm II: GCPGC II (6mg)<br>GCPGC 6mg, sc, once at Day 2 per cycle (in patients receiving chemotherapy at Day 1) | Biological: GCPGC 6mg<br>* Stage I: Single blinded;<br>* Other names: Pegfilgrastim;|
| Experimental: Stage II - Arm I: GCPGC<br>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<br>* Experimental: Stage II<br>* Other names: Pegfilgrastim;|
| Active Comparator: Stage II - Arm II: Neulasta<br>Neulasta 6mg, sc, once at Day 3 per cycle (in patients receiving chemotherapy at Day 1) | Biological: Neulasta (pegfilgrastim) 6mg<br>* Stage II: Active comparator, double blinded<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | in cycle 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Stage I: only in cycle 1; Stage II: in all cycles | in all cycles | 
| Rates of severe neutropenia persisting more than 3 days in cycle 1 (only for Stage II) |  | in cycle 1 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pegfilgrastim, neutropenia