Phase II 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

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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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 1 cycles of chemotherapy.

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 3.6mg

PEG-G-CSF

Group Type EXPERIMENTAL

PEG-G-CSF

Intervention Type DRUG

Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 cycle

DA-3031 6mg

PEG-G-CSF

Group Type EXPERIMENTAL

PEG-G-CSF

Intervention Type DRUG

Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 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 1 cycle

Interventions

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PEG-G-CSF

Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 cycle

Intervention Type DRUG

G-CSF

Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 1 cycle

Intervention Type DRUG

Other Intervention Names

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DA-3031 Leucostim®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No