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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01674855

Acronym

PEG-G-CSF

Enrollment

Registered

2012-08-29

Start date

2012-02-29

Completion date

2013-05-31

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Induced Neutropenia

Keywords

PEG-G-CSF

Brief summary

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

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.

Interventions

DRUGPEG-G-CSF

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

DRUGG-CSF

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026