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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-05-31

Brief Summary

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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.

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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 6 cycles of chemotherapy, that each cycle is repeated every 21 days.

Conditions

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Chemotherapy Induced Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DA-3031

PEG-G-CSF

Group Type EXPERIMENTAL

PEG-G-CSF

Intervention Type DRUG

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

Leucostim®

G-CSF

Group Type ACTIVE_COMPARATOR

G-CSF

Intervention Type DRUG

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

Interventions

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PEG-G-CSF

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

Intervention Type DRUG

G-CSF

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

Intervention Type DRUG

Other Intervention Names

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DA-3031 Leucostim®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No