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

Dong-A ST Co., Ltd.74 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chemotherapy Induced Neutropenia

Interventions

PEG-G-CSFDRUG

Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle

G-CSFDRUG

Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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

Locations (1)

Korea University GURO hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Duration of grade 4 neutropenia in cycle 1

Grade 4 neutropenia means the ANC count is less than 500/mm3.

Time frame: 21 day

Secondary Outcomes

ANC nadir in cycle 1

ANC nadir means the lowest point of ANC count.

Time frame: 21 day

Time to ANC recovery in cycle 1

ANC recovery means the ANC count is more than 2,000/mm3.

Time frame: 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.

Time frame: 126 day

Incidence of IV antibiotics administration

IV antibiotics administration means that antibiotics are administered through intravenous route.

Time frame: 126 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.