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

Dong-A ST

Status and phase: Completed; Phase 2

Conditions: Chemotherapy Induced Neutropenia

Treatments: Drug: G-CSF; Drug: PEG-G-CSF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01923545

DA3031_NP_II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 3 patient groups

DA-3031 3.6mg

Experimental group

Description:

PEG-G-CSF

Treatment:

Drug: PEG-G-CSF

DA-3031 6mg

Experimental group

Description:

PEG-G-CSF

Treatment:

Drug: PEG-G-CSF

Leucostim®

Active Comparator group

Description:

G-CSF

Treatment:

Drug: G-CSF