Phase II 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 examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared 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 1 cycles of chemotherapy.

Official Title
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Multi-Center, Randomized, Open, Phase II 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: Diagnosis of stage II or III breast cancer Age : ≥18, ≤70 TAC regimen as adjuvant therapy 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: Received any other investigational drugs within 30 days of informed consent date Received systemic antibiotics within 72 hours of chemotherapy into this study or Radiation therapy within 4 weeks of informed consent date Infective symptom before chemotherapy into this study Pregnant or lactating women Prior bone marrow or stem cell transplantation Other malignancy history within 5 years HIV positive Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date Prior chemotherapy

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 3.6mg<br>PEG-G-CSF | Drug: PEG-G-CSF<br>* Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 cycle<br>* Other names: DA-3031;|
| Experimental: DA-3031 6mg<br>PEG-G-CSF | Drug: PEG-G-CSF<br>* Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 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 1 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 in cycle 1 | Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius. | 21 day | 
| Incidence of IV antibiotics administration in cycle 1 | IV antibiotics administration means that antibiotics are administered through intravenous route. | 21 day | 

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