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

Phase 3

Completed

• Conditions: Chemotherapy Induced Neutropenia
• Interventions: Drug: PEG-G-CSF; Drug: G-CSF

• Registration Number: NCT01674855
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2012-01-19
• Study Start: 2012-02
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-29
• Primary Completion: 2013-02
• Study Completion: 2013-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-3031	PEG-G-CSF	PEG-G-CSF
Leucostim®	G-CSF	G-CSF

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Korea University GURO hospital; 🇰🇷 Seoul, Korea, Republic of