CompletedPhase 2

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

South Korea61 participantsStarted 2010-07

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosis of stage II or III breast cancer
✓. Age : ≥18, ≤70
✓. TAC regimen as adjuvant therapy
✓. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1
✓. Creatinine \< 1.5 x ULN
✓. Total bilirubin/AST/ALT \< 1.5 x ULN, ALP \< 2.5 x ULN
✓. Have given a written, informed consent

Exclusion criteria

✕. Received any other investigational drugs within 30 days of informed consent date
✕. Received systemic antibiotics within 72 hours of chemotherapy into this study or Radiation therapy within 4 weeks of informed consent date
✕. Infective symptom before chemotherapy into this study
✕. Pregnant or lactating women
✕. Prior bone marrow or stem cell transplantation
✕. Other malignancy history within 5 years
✕. HIV positive
✕. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors within 6 weeks of informed consent date

What they're measuring

Duration of grade 4 neutropenia in cycle 1

Timeframe: 21 day

Trial details

NCT IDNCT01923545

SponsorDong-A ST Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-05

View on ClinicalTrials.gov More Chemotherapy Induced Neutropenia trials