Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
- Conditions
- Neoplasms
- Registration Number
- KCT0000518
- Lead Sponsor
- Dong-A Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 74
(1)Age : =18, =70
(2)Diagnosis of stage II, III or IV breast cancer
(3)ANC=1,500/mm3, Platelet=100,000/mm3, ECOG : 0 or 1
(4)Creatinine < 1.5 x ULN
(5)Total bilirubin/AST/ALT < 1.5 x ULN, ALP < 2.5 x ULN
(6)Have given a written, informed consent
(1)Prior chemotherapy
(2)Prior bone marrow or stem cell transplantation
(3)Other malignancy history within 5 years
(4)Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors
(5)Received any other investigational drugs within 30 days of informed consent date
(6)Radiation therapy within 4 weeks of informed consent date
(7)Infective symptom before chemotherapy into this study
(8)Received systemic antibiotics within 72 hours of randomization into this study.
(9)HIV positive
(10)Pregnant or lactating women
(11)Other case at investigator's discretion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of grade 4 neutropenia in cycle 1
- Secondary Outcome Measures
Name Time Method ANC nadir in cycle 1;Time to ANC recovery in cycle 1;Incidence of febrile neutropenia;Incidence of IV antibiotics adminstration