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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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

Conditions
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Chemotherapy Induced Neutropenia

Intervention / Treatment
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* Drug: PEG-G-CSF
* Drug: G-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age : ≥18, ≤70 Diagnosis of stage II, III or IV breast cancer ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1 Creatinine < 1.5 x ULN Total bilirubin/AST/ALT < 1.5 x ULN, ALP < 2.5 x ULN Have given a written, informed consent Exclusion Criteria: Prior chemotherapy Prior bone marrow or stem cell transplantation Other malignancy history within 5 years Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors Received any other investigational drugs within 30 days of informed consent date Radiation therapy within 4 weeks of informed consent date Infective symptom before chemotherapy into this study Received systemic antibiotics within 72 hours of randomization into this study. HIV positive Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-3031<br>PEG-G-CSF | Drug: PEG-G-CSF<br>* Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle<br>* Other names: DA-3031;|
| Active Comparator: Leucostim®<br>G-CSF | Drug: G-CSF<br>* Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle<br>* Other names: Leucostim®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of grade 4 neutropenia in cycle 1 | Grade 4 neutropenia means the ANC count is less than 500/mm3. | 21 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ANC nadir in cycle 1 | ANC nadir means the lowest point of ANC count. | 21 day | 
| Time to ANC recovery in cycle 1 | ANC recovery means the ANC count is more than 2,000/mm3. | 21 day | 
| Incidence of febrile neutropenia | Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius. | 126 day | 
| Incidence of IV antibiotics administration | IV antibiotics administration means that antibiotics are administered through intravenous route. | 126 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG-G-CSF