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

Phase 2

Completed

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

• Registration Number: NCT01923545
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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.

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 1 cycles of chemotherapy.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-15
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-3031 6mg	PEG-G-CSF	PEG-G-CSF
DA-3031 3.6mg	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 in cycle 1	21 day	Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius.
Incidence of IV antibiotics administration in cycle 1	21 day	IV antibiotics administration means that antibiotics are administered through intravenous route.

Trial Locations

Locations (1)

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