Overview

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

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dong-A ST Co., Ltd.
Treatments:
Lenograstim
Criteria
Inclusion Criteria:

1. Diagnosis of stage II or III breast cancer

2. Age : ≥18, ≤70

3. TAC regimen as adjuvant therapy

4. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1

5. Creatinine < 1.5 x ULN

6. Total bilirubin/AST/ALT < 1.5 x ULN, ALP < 2.5 x ULN

7. Have given a written, informed consent

Exclusion Criteria:

1. Received any other investigational drugs within 30 days of informed consent date

2. Received systemic antibiotics within 72 hours of chemotherapy into this study or
Radiation therapy within 4 weeks of informed consent date

3. Infective symptom before chemotherapy into this study

4. Pregnant or lactating women

5. Prior bone marrow or stem cell transplantation

6. Other malignancy history within 5 years

7. HIV positive

8. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors
within 6 weeks of informed consent date

9. Prior chemotherapy